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Journal articles on the topic 'Bioavailability – Research – Statistical methods'

Author: Grafiati

Published: 30 June 2021

Last updated: 6 February 2022

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1

Kruijtzer, C. M. F., J. H. Beijnen, H. Rosing, W. W. ten Bokkel Huinink, M. Schot, R. C. Jewell, E. M. Paul, and J. H. M. Schellens. "Increased Oral Bioavailability of Topotecan in Combination With the Breast Cancer Resistance Protein and P-Glycoprotein Inhibitor GF120918." Journal of Clinical Oncology 20, no. 13 (July 1, 2002): 2943–50. http://dx.doi.org/10.1200/jco.2002.12.116.

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PURPOSE: We discovered that breast cancer resistance protein (BCRP), a recently identified adenosine triphosphate–binding cassette drug transporter, substantially limits the oral bioavailability of topotecan in mdr1a/1b(−/−) P-glycoprotein (P-gp) knockout and wild-type mice. GF120918 is a potent inhibitor of BCRP and P-gp. The aim was to increase the bioavailability of topotecan by GF120918. PATIENTS AND METHODS: In cohort A, eight patients received 1.0 mg/m2 oral topotecan with or without coadministration of one single oral dose of 1,000 mg GF120918 (day 1 or day 8). In cohort B, eight other patients received 1.0 mg/m2 intravenous topotecan with or without 1,000 mg oral GF120918 to study the effect of GF120918 on the systemic clearance of topotecan. RESULTS: After oral topotecan, the mean area under the plasma concentration-time curve (AUC) of total topotecan increased significantly from 32.4 ± 9.6 μg·h/L without GF120918 to 78.7 ± 20.6 μg·h/L when GF120918 was coadministered (P = .008). The mean maximum plasma concentration of total topotecan increased from 4.1 ± 1.5 μg/L without GF120918 to 11.5 ± 2.4 μg/L with GF120918 (P = .008). The apparent bioavailability in this cohort increased significantly from 40.0% (range, 32% to 47%) to 97.1% (range, 91% to 120%) (P = .008). Interpatient variability of the apparent bioavailability was 17% without and 11% with GF120918. After intravenous administration of topotecan, coadministration of oral GF120918 had a small but statistically significant effect on the AUC and systemic clearance of total topotecan but no statistically significant effect on maximum plasma concentration and terminal half-life of total topotecan. CONCLUSION: Coadministration of the BCRP and P-gp inhibitor GF120918 resulted in a significant increase of the systemic exposure of oral topotecan. The apparent oral bioavailability increased from 40.0% without to 97.1% with GF120918.

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van Leeuwen, Roelof W. F., Robert Peric, Koen G. A. M. Hussaarts, Emma Kienhuis, Nikki S. IJzerman, Peter de Bruijn, Cor van der Leest, et al. "Influence of the Acidic Beverage Cola on the Absorption of Erlotinib in Patients With Non–Small-Cell Lung Cancer." Journal of Clinical Oncology 34, no. 12 (April 20, 2016): 1309–14. http://dx.doi.org/10.1200/jco.2015.65.2560.

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Purpose Erlotinib depends on stomach pH for its bioavailability. When erlotinib is taken concurrently with a proton pump inhibitor (PPI), stomach pH increases, which results in a clinically relevant decrease of erlotinib bioavailability. We hypothesized that this drug-drug interaction is reversed by taking erlotinib with the acidic beverage cola. The effects of cola on erlotinib bioavailability in patients not treated with a PPI were also studied. Patients and Methods In this randomized, cross-over, pharmacokinetic study in patients with non–small-cell lung cancer, we studied intrapatient differences in absorption (area under the plasma concentration time curve [AUC0-12h]) after a 7-day period of concomitant treatment with erlotinib, with or without esomeprazole, with either cola or water. At the 7th and 14th day, patients were hospitalized for 1 day for pharmacokinetic sampling. Results Twenty-eight evaluable patients were included in the analysis. In patients treated with erlotinib and esomeprazole with cola, the mean AUC0-12h increased 39% (range, −12% to 136%; P = .004), whereas in patients not treated with the PPI, the mean AUC0-12h was only slightly higher (9%; range, −10% to +30%; P = .03) after erlotinib intake with cola. Conclusion Cola intake led to a clinically relevant and statistically significant increase in the bioavailability of erlotinib during esomeprazole treatment. In patients not treated with the PPI, the effects of cola were marginal. These findings can be used to optimize the management of drug-drug interactions between PPIs and erlotinib.

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Selvaraj, Brito R., Seshaiah K. Sridhar, Bhaskar R. Kesavan, and Sucharitha Palagati. "Application of Statistical Tooling Techniques for Designing of Carvedilol Nanolipid Transferosomes and its Dermatopharmacokinetic and Pharmacodynamic Studies." Pharmaceutical Nanotechnology 8, no. 6 (December 28, 2020): 452–70. http://dx.doi.org/10.2174/2211738508666200928164820.

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Background: The hypothesis is to augment the bioavailability and therapeutic potential of low bioavailable Carvedilol (25-35%) through Nanostructured Lipid Carrier (NLC) loaded Transdermal patch (Nanolipid Transferosomes). Methods: Box-Behnken design was designed to formulate NLC through a hot homogenization technique. About 17 formulations (C1-C17) were formulated by varying the critical material attribute and critical process parameter. Optimization was done based on its critical quality attributes like particle size, zeta potential and entrapment efficiency. Selected NLC (C16) has been fabricated into a transdermal patch through solvent evaporation technique and estimated for thickness, weight variation, moisture content, folding endurance, drug content, in vitro drug release, ex vivo skin permeation studies 48 hrs, in vitro drug release kinetic studies and skin irritation studies. In vivo pharmacokinetics and pharmacodynamic study parameters were compared between carvedilol loaded NLC transdermal patch and a conventional formulation (Coreg CR). Results: NLC (C16) was selected as the best formulation based on desirable, less particle size (201.1 ± 2.02 nm), more zeta potential (-37.2 ± 1.84mV) and maximum entrapment efficiency (87.54 ± 1.84%). Experimental investigations of in vivo dermatopharmacokinetic data shown statistically significant changes (p<0.05) in the parameter (increased AUC0-α, MRT with decreased Cmax, Tmax) when administered through the transdermal patch and on compared to the conventional dosage form. It was observed that there was a significant change with p<0.05 among the pharmacokinetic factors of conventional Carvedilol formulation, Carvedilol NLC and Carvedilol NLC loaded Transdermal patch with a maximum time of peak plasma concentration (Tmax) of 4 hrs, 8 hrs and 8 hrs; maximum peak plasma concentration (Cmax) of 0.258 μg/ml, 0.208 μg/ml and 0.108 μg/ml. Area Under Curve (AUC0-α) was established to be 125.127 μg/ml/h, 132.576 μg/ml.h and 841.032 μg/ml.h. Mean Residence Time (MRT0- α) of the drug was established to be 17 hrs, 19 hrs and 82 hrs, respectively. This data reveals the impact of NLC on the enhancement of bioavailability through a transdermal patch. In vivo pharmacodynamic studies confirm that NLC loaded transdermal patch (Nanolipid Transferosomes) shows a significant control in blood pressure for 48 hrs when compared to the conventional dosage form. Conclusion: This research data concludes that NLC loaded transdermal patch (Nanolipid Transferosomes) was a suitable candidate to enhance the bioavailability of low bioavailable drug-like Carvedilol. Lay Summary: It was inferred from the literature that NLC filled transdermal patches were a novel strategy to increase the solubility and permeability of Carvedilol, which has less bioavailability. It reveals that there was no reproducible preparation for the NLC. It also reveals that the option of formulation and process parameters for the formation of NLC is not clearly justified. On account of this, an uniquely validated and optimized formulation technique was developed for NLC with low soluble and poorly bioavailable carvedilol, tested in Albino wistar rats for enhancement of bioavailability, the same study has been performed and proved.

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Urminská, Jana, Tomáš Tóth, Renáta Benda Prokeinová, and Peter Ondrišík. "The effect of the selected remediation medium on the cadmium bioavailability in the selected ecosystem in the Southwestern locality of Slovakia." Ekológia (Bratislava) 38, no. 3 (September 1, 2019): 214–24. http://dx.doi.org/10.2478/eko-2019-0017.

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AbstractSoil is a sensitive ecological factor. Biodegradable materials from the environment can also be used to deal with serious ecological problems. Soil affecting by remediation medium - garden compost - was analysed for toxic cadmium (Cd) in terms of environmental protection. The objective of this research was to analyse soil and compost at foothill locality of the Tribeč Mountains (Southwestern Slovakia) in the years 2015−2017 to determine Cd contents in soil and compost, pH and to assess Cd bioavailability. The analyses were carried out using the Atomic Absorption Spectrometry with seven-step Selective Sequential Extraction methods. The results obtained were evaluated statistically using the SAS 9.4 software method by Spearman’s correlation coefficient. The results showed that Cd contents in soil had reached 2.96 mg kg−1 and soil with compost (the ratio 1:1) 2.71 mg kg−1 dry matter. Cd contents in the soil exceeded maximum allowed limit of 196%. And deceased by 25% after adding compost. The pH in soil with compost varied from 6.78 to 7.98. The pH prevented the mobility of Cd about 8.3% in average. Statistical dependence was high, which was demonstrated for relationship between Cd in soil, pH and compost. Available Cd forms in soil were 53.3% and soil with compost were 45% in average. The garden compost as a remediation medium reduced Cd bioavailability.

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Zhang, Xuhuiqun, Amandeep Sandhu, Jiayi Fan, Di Xiao, Indika Edirisinghe, and Britt Burton-Freeman. "Metabolic Status and Gender Affect the Absorption and Metabolism of Red Raspberry (Poly)phenols." Current Developments in Nutrition 5, Supplement_2 (June 2021): 385. http://dx.doi.org/10.1093/cdn/nzab037_095.

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Abstract Objectives Red raspberries are rich in bioactive (poly)phenols, particularly anthocyanins and ellagitannins. A substantial amount of variability is observed in the bioavailability and metabolism of (poly)phenols in humans. This study aimed to investigate the potential factors, i.e., metabolic status, body mass index (BMI), age, gender and race, on (poly)phenol metabolism in individuals with different health statuses. Methods After 3-day wash-in and overnight fasting, subjects (n = 65, male: female 32:33, age 34 ± 1 years, BMI 27 ± 1 kg/m2, mean ± SEM) consumed 250 g red raspberries (2 cups equivalence). Plasma samples collected over 24 h were quantified for (poly)phenolic metabolites using an ultra-high performance liquid chromatography coupled with triple quadrupole (UHPLC-QQQ). Statistical analysis was performed using PC-SAS. Results Individuals with prediabetes and insulin-resistance (n = 45) had significantly higher bioavailability of cyanidin sophoroside (0.21 ± 0.02% vs. 0.14 ± 0.03%, P = 0.04) and cyanidin 3-O-glucoside (0.12 ± 0.01% vs. 0.09 ± 0.01%, P = 0.02), and lower area under the 24 h curve (AUC0–24h) of hippuric acid glucuronide (435 ± 123 nmol/L × h vs. 1011 ± 184 nmol/L × h, P = 0.01) compared to healthy individuals (n = 20). Females (n = 33) had significantly lower bioavailability of cyanidin 3-O-glucoside (0.09 ± 0.01% vs. 0.13 ± 0.01%, P = 0.04) compared to males (n = 32). Correlation analysis on all subjects (n = 65) identified that bioavailability of cyanidin sophoroside and cyanidin 3-O-glucoside negatively correlated with fasting plasma triglyceride and positively correlated with HOMA-IR, HOMA-β, and fasting insulin concentration (P < 0.05). The AUC0–24h of hippuric acid glucuronide negatively correlated with fasting plasma glucose and triglyceride concentrations. Conclusions Individuals with different metabolic status and gender have different capacity to absorb and metabolize red raspberry (poly)phenols. The data provide insight for personalized nutrition for optimal health benefits and suggest further research on possible mechanisms involved. Funding Sources This project was funded by the National Processed Raspberry Council and various donor funds to the Center for Nutrition Research, Illinois Institute of Technology.

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Hussaini, Azra, Anthony J. Olszanski, Cy Aaron Stein, Bill Bosch, and Paul Nemeth. "Relative bioavailability (BA) and bioequivalence (BE) study of abiraterone acetate (AA) fine particle (AAFP) with methylprednisolone (MP) and a reference formulation with prednisone (PN) in healthy male subjects." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): e16538-e16538. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e16538.

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e16538 Background: AA is approved for treatment of metastatic castration-resistant prostate cancer when taken in combination with PN. The originator AA (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic (PK) variability. AAFP is a proprietary formulation (utilizing SoluMatrix Fine-Particle Technology™) that was designed to provide improved BA. In a prior study in healthy subjects, AAFP 500 mg was established as bioequivalent to OAA 1000 mg when given in the fasted state. In this study, AAFP was evaluated in subjects in a fasted state with steady state (SS) MP, an alternative steroid to PN. Methods: Subjects aged 18–50 years were randomized in a crossover design to receive MP (4 mg BID) or PN (5 mg BID) for 12 days in Period 1. On Day 11 of Period 1, subjects given MP received a single dose of AAFP 500 mg (test) and subjects given PN received a single dose of OAA 1000 mg (reference). After a 2-week steroid washout period, subjects received the alternate treatments in Period 2. Results: There were no statistical differences with regard to abiraterone AUC ( P≥0.38) and Cmax ( P= 0.22) between AAFP 500 mg and OAA 1000 mg (Table). Geometric mean ratio (GMR), a measure of BE, was 95.9% (90% CI: 86.0–106.9%) for AUC0-∞, 99.2% (90% CI: 88.7–110.9%) for AUC0-t, and 116.8% (90% CI: 102.2–133.4%) for Cmax. GMR of AUC0-∞ and AUC0-t, fell within the 80–125% range for BE, and Cmax 90% CI was just outside the upper limit. The coefficient of variance (CV) for both AUC and Cmaxwas smaller for AAFP compared with OAA. Both treatments were safe and well tolerated. Conclusions: AAFP 500 mg with MP gave comparable exposure to OAA 1000 mg with PN with respect to Cmaxand AUC. Less drug exposure variability was observed with AAFP compared with OAA. Reduced PK variability could improve clinical outcomes and warrants further study. [Table: see text]

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Morris, Claudia R., Frans Kuypers, Robert W. Hagar, Michael Ansari, Sandra K. Larkin, Lisa Lavrisha, Meghan Wardlaw, Alicia Zhou, Elliott Vichinsky, and Jung H. Suh. "Metabolic Fate of Oral Glutamine Supplementation within Plasma and Erythrocytes of Patients with Sickle Cell Disease: Preliminary Pharmacokinetics Results." Blood 116, no. 21 (November 19, 2010): 1636. http://dx.doi.org/10.1182/blood.v116.21.1636.1636.

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Abstract Abstract 1636 Introduction: The erythrocyte redox environment may contribute to increased hemolysis and decreased nitric oxide (NO) bioavailability in pulmonary hypertension (PH) of sickle cell disease (SCD). Glutathione (GSH) is the principal thiol redox buffer in erythrocytes and its depletion has been linked to hemolysis. Glutamine plays an additional anti-oxidant role through preservation of the intracellular nicotinamide adenine dinucleotide (NAD) levels, required for reducing GSSG back to GSH. Altered GSH and glutamine metabolism will promote hemolysis and contribute to altered redox homeostasis. Glutamine depletion and low levels of the obligate NO substrate L-arginine are associated with pulmonary hypertension (PH) in SCD. Low arginine bioavailability is also associated with increased mortality risk. Pilot data of L-glutamine therapy has been associated with improved vasculopathy and increased NAD redox potential in SCD. Targeting these deficiencies in SCD has generated interest, however, little information on the pharmacokinetics (pK) is currently available. Methods: We performed pK studies to determine the metabolic fate of glutamine supplementation on plasma and erythrocyte amino acids in patients with SCD. Patients fasting for > 8 hours received 10 grams of L-glutamine powder mixed with Gatorade. Blood was analyzed at baseline, 30, 60, 90, 2hr, 3hr, 4hr and 8hrs after ingesting study drug. A standardized diet was administered to all participants at 3 established time-points (after 2hr, 5hr and 7 hrs). A subset of patients also had pK studies performed without study drug to follow normal diurnal fluctuations in amino acids. Results: We report data on 5 patients with SCD, three of whom performed pK studies both with and without glutamine supplementation. Average age was 50.6 ±5.6 years, 60% were female, 40% SS, 60% SC, and 4 had PH (mean TRV=3.4±0.8m/s, range 3.0–4.6m/s) while one patient had a TRV=2.25 and no history of PH. Diurnal variations in many amino acids were observed. However plasma glutamine levels more than doubled after oral glutamine supplementation, compared to minimal fluctuations with diet. Plasma glutamine concentration peaked within 30 minutes of ingestion (p=0.01) before decreasing to a plateau by 2 hours that remained higher than baseline by 8 hours. Oral glutamine also increased plasma arginine concentration, which peaked by 4 hrs (p=0.03) and remained elevated through 8 hrs (FigB). Global arginine bioavailability (plasma arginine/(ornithine+ citrulline) also increased (0.67± 0.2 to 1.83±0.6, p=0.02). Erythrocyte glutamine levels began to increase by 8 hours, (Fig 1C), while erythrocyte arginine concentration peaked at 4 hours. Anecdotally, the greatest improvement in intracellular arginine bioavailability occurred in our patient with severe PH and a TRV=4.6 (Fig 1D). The erythrocyte glutamine/glutamate ratio peaked at 1–2 hrs, as did the erythrocyte glutathione concentration, although these trends did not reach statistical significance. Conclusions: Oral glutamine supplementation (10 gm) acutely improves glutamine and arginine bioavailability in both plasma and erythrocytes. The clinical implications of these observations remain to be determined, however this represents a promising novel therapy for hemoglobinopathies. Phase II studies of glutamine supplementation targeting PH patients with SCD or thalassemia are ongoing at Children's Hospital & Research Center Oakland. Disclosures: Off Label Use: L-glutamine - an amino acid that may improve arginine bioavailability. IND held by C. Morris.

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Dhillon, N., B. B. Aggarwal, R. A. Newman, R. A. Wolff, A. B. Kunnumakkara, J. L. Abbruzzese, D. S. Hong, L. H. Camacho, C. Ng, and R. Kurzrock. "Curcumin and pancreatic cancer: Phase II clinical trial experience." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 4599. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.4599.

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4599 Background: Pancreatic cancer is virtually always lethal, and the only FDA-approved therapies–gemcitabine and erlotinib–produce objective responses in less than 10% of patients. Curcumin (diferuloyl methane) is a plant-derived dietary ingredient that suppresses NF-κB and numerous other pathways relevant to pancreatic cancer and has potent preclinical anti-tumor activity. Herein, we evaluated the safety and potential antitumor activity of curcumin against advanced pancreatic cancer, and its impact on biologic correlates. Methods: Patients received 8 grams of curcumin by mouth daily for two months and were then restaged. Maintenance therapy was continued at the same dose and schedule until disease progression. Results: Twenty-five patients were enrolled as of the date of analysis, with 21 evaluable for response. Circulating curcumin was detectable, albeit at low steady-state levels (about 31 ng/ml), suggesting poor oral bioavailability. To date, two patients have had prolonged stable disease (8 and 12+ months). Interestingly, one patient had a brief, but marked tumor regression (73%) (accompanied by significant increases (4–35-fold) in serum cytokine (interleukin-6 (IL-6), IL-8, IL-10, and IL-1 receptor antagonist (IL-1RA) levels). No toxicities have been observed. Curcumin down-regulated expression of NF-κB, COX-2 and phosphorylated STAT3 in peripheral blood mononuclear cells (PBMC) from patients (most of whom had baseline levels considerably higher than those found in healthy volunteers)although the decrease did not reach statistical significance for p65. Curcumin was determined in patient plasma samples after enzymatic digestion with glucuronidase enzyme. While there was considerable variation in plasma curcumin levels from patient to patient, drug levels peaked at 22–41 ng/ml and remained relatively constant over the entire 4 week experimental period. Conclusions: We conclude that oral curcumin is well tolerated and, despite its limited absorption, has biologic activity in patients with pancreatic cancer. [Table: see text] No significant financial relationships to disclose.

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Lalani, Aly-Khan A., Rana R. McKay, Xun Lin, Ronit Simantov, Marina D. Kaymakcalan, and Toni K. Choueiri. "Proton pump inhibitors (PPIs) and survival outcomes in patients with metastatic renal cell carcinoma (mRCC)." Journal of Clinical Oncology 35, no. 6_suppl (February 20, 2017): 493. http://dx.doi.org/10.1200/jco.2017.35.6_suppl.493.

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493 Background: PPIs are potent inhibitors of gastric acid secretion and can affect the bioavailability of orally administered cancer targeting therapies, such as vascular endothelial growth factor tyrosine-kinase inhibitors (VEGF-TKIs). Smaller preclinical and clinical studies have attempted to assess the interaction between VEGF-TKIs and PPIs in patients with advanced cancers; however, these studies are limited and larger analyses from rigorous datasets have been lacking. We investigate the impact of PPI use on survival in patients with mRCC treated with oral VEGF-TKIs. Methods: A pooled analysis of mRCC patients treated on phase II and III clinical trials was conducted. The primary outcome was to assess overall survival (OS) between PPI users, defined as patients receiving a PPI at baseline, compared to non-PPI users. Secondary outcomes included progression-free survival (PFS), objective response rates (ORR), and adverse events. Statistical analyses were performed using Cox regression adjusted for several risk factors and the Kaplan-Meier method. Results: Our cohort consisted of 2,188 patients treated with sunitinib (n = 952), axitinib (n = 626), or sorafenib (n = 610), of whom 120 were PPI users. Overall, PPI users demonstrated similar OS compared to non-PPI users (median 24.1 vs. 21.3 months, adjusted hazard ratio [aHR] 1.051, 95% confidence interval (CI) 0.769-1.438, p = 0.754). Similarly, PFS (5.5 vs. 8.0 months, aHR 1.016, 95% CI 0.793-1.301, p = 0.902) and ORR (23.3% versus 27.4%, p = 0.344) were not different between PPI users and non-users. These findings were consistent across International mRCC Database Consortium risk groups and by line of therapy. Adverse events were also similar between both groups. Conclusions: In this analysis, we demonstrate that PPI use does not appear to negatively impact the efficacy of VEGF-TKIs in mRCC patients treated in the targeted therapy era. Given the current landscape expanding to include more self-administered treatments, documentation of concomitant medications, and patient education on potential drug interactions are critical for optimizing the utilization of oral cancer targeting therapy.

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Nagler, Arnon, Vanderson Rocha, Myriam Labopin, Ali Unal, Tarek Ben Othman, Antonio Campos, Liisa Volin, et al. "Allogeneic Hematopoietic Stem-Cell Transplantation for Acute Myeloid Leukemia in Remission: Comparison of Intravenous Busulfan Plus Cyclophosphamide (Cy) Versus Total-Body Irradiation Plus Cy As Conditioning Regimen—A Report From the Acute Leukemia Working Party of the European Group for Blood and Marrow Transplantation." Journal of Clinical Oncology 31, no. 28 (October 1, 2013): 3549–56. http://dx.doi.org/10.1200/jco.2013.48.8114.

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Purpose Cyclophosphamide (Cy) combined with total-body irradiation (TBI) or with busulfan (Bu) are currently the most common myeloablative regimens used in allogeneic stem-cell transplantation (alloSCT) in adults with acute myelogenous leukemia (AML). Intravenous (IV) Bu has more predictable bioavailability and a safer toxicity profile than the oral formulation. Comparative studies of outcomes have been performed between oral Bu/Cy and Cy/TBI, but there have been no comparative trials in the era of IV Bu. Patients and Methods We performed a retrospective registry-based study comparing outcomes of patients with AML in first or second remission after alloSCT from sibling donors who underwent IV Bu/Cy (n = 795) or Cy/TBI (n = 864) conditioning. Results Engraftment rate was 98% and 99% after IV Bu/Cy and Cy/TBI, respectively. Grade 2 to 4 acute graft-versus-host disease (GVHD) was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P < .001). Similarly, chronic GVHD was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P = .003). Cumulative incidence of 2-year nonrelapse mortality (NRM; ± standard deviation [SD]) was 12% ± 1% in the IV Bu/Cy group and 15% ± 2% in the Cy/TBI group (P = .14), and 2-year relapse incidence (RI; ± SD) was 26% ± 3% and 21% ± 1%, respectively (P = .012). Leukemia-free survival (LFS) rate (± SD) was 61% ± 2% after IV Bu/Cy and 64% ± 2% after Cy/TBI (P = .27). In multivariable analysis, adjusting for differences between both groups, patients who received IV Bu/Cy had lower acute and chronic GVHD, higher RI, and a trend toward lower NRM. LFS was not statistically different between the two conditioning regimens. Conclusion This retrospective study shows that final outcomes after myeloablative conditioning using IV Bu/Cy were not statistically different from those after Cy/TBI.

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Umanzor Funez, Gerardo Antonio, Hope S. Rugo, Jorge Umanzor, Francisco Barrios, Rosa Vasallo, M. Chivalan, Suyapa A. Bejarano, et al. "Confirmed tumor response by molecular subtype in patients with metastatic breast cancer: Sub-analysis from a phase 3 clinical study comparing oral paclitaxel and encequidar to IV paclitaxel." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 1073. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.1073.

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1073 Background: Paclitaxel, a foundation treatment in MBC, is hydrophobic and must be formulated for IV administration with Cremophor EL, increasing the risk of infusion reactions and necessitating pre-treatment with corticosteroids and antihistamines. Paclitaxel cannot be administered orally because it is a substrate for P-gp. The oral bioavailability of paclitaxel is improved when administered 1 hour after the highly selective, potent, and minimally absorbed P-gp inhibitor encequidar. As oral paclitaxel is Cremophor-free there is no need for pretreatment for infusion reactions. While targeted therapies have improved outcomes in patients with HER2+ tumors there is still an unmet need for therapies that prolong survival with reduced toxicity across all tumor subtypes. Methods: A phase 3, open-label, randomized, multicenter study in women with histologically- or cytologically-confirmed MBC for whom treatment with IV paclitaxel monotherapy had been recommended by their oncologist randomized 402 patients 2:1 to either oral paclitaxel and encequidar (oPac+E) or IV paclitaxel (IVPac). Oral paclitaxel 205 mg/m2 was administered once daily for 3 consecutive days, weekly. Encequidar 12.9 mg was administered 1 hour before each dose of oral paclitaxel. IV paclitaxel 175 mg/m2 was infused over 3 hours on day 1 of every 3 weeks. Results: In the ITT population oPac+E was superior to IV paclitaxel with a confirmed tumor response rate of 35.8% vs 23.4% for IVPac: a difference of 12.4% (p = 0.0107). A post-hoc subgroup efficacy analysis was conducted based on tumor subtypes, however, the study was not powered to detect statistical differences within these subgroups. Patients in the HR+/HER2- subgroup had a better tumor response to oPac+E (44.8% vs 21.4% IVPac-response rate difference of 23.4%) as did patients in the TNBC (30.5% vs 20.2%-response rate difference of 10.3%) subgroup. Responses were similar (49% vs 47.4% IVPac) in the HER2+ subgroup. Patients with unknown HER2 status receiving oPac+E had a 58.8% response rate vs 14.3% with IVPac (response rate difference of 44.5%). Conclusions: oPac+E is the first oral taxane to demonstrate superiority in radiologically confirmed tumor response rate compared to IVPac in a group of 402 women with metastatic breast cancer. Patients with HR+/HER2-, TNBC, and Unknown subtypes responded considerably better to oPac+E vs IVPac—especially the HR+/HER2- subtype which represented 63% of the patients treated with oPac+E and 55% of the patients treated with IVPac. Clinical trial information: NCT 02594371 .

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Hsu, CS, W.-H. Hao, J.-J. Wang, T.-H. Lin, and R.-Y. Kuo. "Antitumor efficacy and pharmacokinetics of a novel gemcitabine oral formulation (INNO-D07001) in xenograft animal models." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e14699-e14699. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14699.

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e14699 Background: INNO-D07001 is a novel oral gemcitabine formulation which was developed to enhance the oral bioavailability of gemcitabine and it has been successfully demonstrated in both beagle dogs as well as nude mice. The objectives of this study were to examine the antitumor activity of this novel gemcitabine oral formulation in human xenograft models of pancreatic tumors with different daily doses as well as various dosing schedules. Methods: The INNO-D07001 dosing solutions (gemcitabine oral formulation) were formulated freshly before treatment and water for injection (USP) was used as the diluent. There were seven groups in the study and it was ten female NCr-nu/nu mice (with human CFPAC-1 pancreatic tumor) per group. Two doses (5 mg/kg and 10 mg/kg) and three dosing schedules (Q1D, Q2D, and Q3D) were examined. Water for injection (by oral administration) was used as the blank control and Gemzar (180 mg/kg by I.V.) was used as the active control. All INNO-D07001 dosing solutions were administered to mice by P.O. and, on the other hand, Gemzar was administered to mice by I.V. All animals were designed to receive doses for 12 days based on different doses and dosing schedules. Total body weights and tumor sizes were recorded continuously for evaluating the toxicity and antitumor activity, respectively, of INNO-D07001. Results: Oral administration of INNO-D07001 once daily at doses of 10 and 5 mg/kg/dose was not tolerated. In contrast, oral administration of INNO-D07001 on a Q2Dx6 schedule at a dose of 10 mg/kg/dose and on a Q3Dx4 schedule at doses of 10 and 5 mg/kg/dose was well tolerated. Moreover, the INNO-D07001 treatment at a dose of 10 mg/kg/dose on a Q2Dx6 schedule produced statistically significant inhibition of tumor growth (i.e. more than 60% inhibition rate comparing to the blank control) on the last treatment day. Conclusions: The novel gemcitabine oral formulation (INNO-D07001) is well tolerated and effective at a dose of 10 mg/kg/dose on a Q2Dx6 schedule to show the significant inhibition of pancreatic tumor growth. Future preclinical study in toxicity evaluation with repeating doses is ongoing in order to provide adequate safety information before entering phase I clinical study.

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Kumar, Inder, Dipima Chaudhary, Bhumika Thakur, and Vinay Pandit. "Formulation and Evaluation of Piroxicam Fast Dissolving Tablets Using Direct Compression and Sublimation Method." Journal of Drug Delivery and Therapeutics 10, no. 3-s (June 15, 2020): 17–25. http://dx.doi.org/10.22270/jddt.v10i3-s.4063.

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Objective: In the present research work, fast dissolving tablets of Piroxicam were formulated by two different techniques i.e. direct compression method and sublimation method using different superdisintegrants. Methods: Twelve formulations were prepared (PXM1 to PXM12) in which first six formulation were prepared by direct compression technique and other six formulation were prepared by sublimation method by using camphor as a sublimating agent. Result and Discussion: All the formulations were subjected for precompression, post compression parameters, and shows all the data within the specific limits. Formulation PXM4 containing 5 % crospovidone showed 99.480 ± 0.291 % drug release in 20 min which was more than the drug release of rest of the formulations. The optimized formulation PXM4 was compared with the marketed formulation and it revealed that drug release of PXM4 was found to be 99.397 ± 0.751 % in 20 min, which was greater than the marketed formulation. Finally, results were statistically analysed by the application of one way ANOVA and t-test. The stability study of the optimized formulation PXM4 showed no significant changes in, drug content, disintegration time and in-vitro drug release. Conclusion: Piroxicam can be successfully prepared using direct compression technique and it will enhance the drug dissolution, which will further increase absorption and bioavailability of the drug. Keywords: Direct compression, fast dissolving tablets, sublimation, Piroxicam.

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Greenberg, E. R., Ta Stukel, J. A. Baron, and D. H. Freeman. "Statistical methods in research." Lancet 342, no. 8878 (October 1993): 1055. http://dx.doi.org/10.1016/0140-6736(93)92911-c.

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Cody, Rebecca L., and Marion K. Slack. "Crossover Design in Pharmacy Research." Annals of Pharmacotherapy 26, no. 3 (March 1992): 327–33. http://dx.doi.org/10.1177/106002809202600303.

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OBJECTIVE: Reports of pharmacy research using crossover designs were reviewed to determine if the studies adequately consider interaction effects and use appropriate statistical analyses. DATA SOURCES: All crossover studies published in DICP, The Annals of Pharmacotherapy during 1988 and 1989 were analyzed. STUDY SELECTION: Reports of crossover studies were included only if at least two treatments were applied in a different order to two or more groups of subjects. DATA EXTRACTION: The principal characteristics of crossover studies and the critical design variables were listed and each study analyzed according to these variables. The critical design variables included consideration of period, sequence, and carryover effects as well as the presentation of data by groups and the use of multivariate statistical analysis. The analysis was conducted independently by each author and conflicts were discussed until consensus was obtained. RESULTS: A total of 11 crossover studies were identified: 6 were bioavailability trials, 3 were treatment comparisons, and 2 had multiple objectives. The possibility of period, sequence, or carryover effects was less with bioavailability studies than with treatment comparisons. Only 1 study presented data by group and only 4 studies used multivariate analysis. CONCLUSIONS: The crossover design appears more appropriate for bioavailability trials than for treatment trials in pharmacy research. Analysis of data from crossover designs could be improved by presenting the data for each treatment group and using multivariate statistical analysis.

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Trang, Michael, Justin C. Bader, Eric A. Ople, William G. Kramer, Michael R. Hodges, Sujata M. Bhavnani, and Christopher M. Rubino. "1340. Population Pharmacokinetic (PK) Analysis of APX001 Using Phase 1 Data." Open Forum Infectious Diseases 5, suppl_1 (November 2018): S409—S410. http://dx.doi.org/10.1093/ofid/ofy210.1172.

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Abstract Background APX001 is a novel antifungal agent which is rapidly converted to the active metabolite APX001A. APX001A exhibits in vitro activity against many clinically important yeast and fungi, including echinocandin- and azole-resistant Candida species. Given this activity, intravenous (IV) and oral (PO) formulations of APX001 are being developed for the treatment of patients with candidemia or invasive candidiasis. Phase 1 data were used to develop a population PK (PPK) model to describe the time-course of APX001A in plasma. Methods The PPK model was developed using 3,736 plasma PK samples collected from 128 healthy subjects who received APX001 single and multiple IV and PO doses ranging from 10 to 1,000 mg. Instantaneous conversion was assumed by scaling input doses by the molecular weight ratio of APX001A to APX001. After development of the structural PK model, stepwise forward and backward selection procedures were used to identify significant covariate relationships. Model qualification included standard goodness-of-fit metrics and prediction-corrected visual predictive check (PC-VPC) plots. Results A two-compartment model with zero-order IV input, or first-order PO absorption with lag time to account for the apparent delay in oral absorption, best described APX001A plasma PK. Exponential error models were used to estimate interindividual variability (IIV) for all parameters. Interoccasion variability was estimated for the absorption rate constant, bioavailability, and lag time. Body weight was identified as a statistically significant predictor of the IIV on the volume of the central and peripheral compartments. The PPK model provided an accurate and unbiased fit to the plasma data based on individual- and population-predicted concentrations (r2 = 0.977 and 0.873, respectively). The PC-VPC plots for the final PPK model (Figure 1) demonstrated good alignment between observed concentrations and the model predicted 5th, 50th, and 95th percentiles. Conclusion A PPK model describing APX001A plasma PK following IV or PO doses was successfully developed. This model will be useful for generating simulated APX001A exposures for use in pharmacokinetic–pharmacodynamic target attainment analyses to support APX001 dose selection. Disclosures M. Trang, Amplyx Pharmaceuticals, Inc.: Research Contractor, Research support. J. C. Bader, Amplyx Pharmaceuticals, Inc.: Research Contractor, Research support. E. A. Ople, Amplyx Pharmaceuticals, Inc.: Employee, Salary. W. G. Kramer, Amplyx Pharmaceuticals, Inc.: Scientific Advisor, Consulting fee. M. R. Hodges, Amplyx Pharmaceuticals, Inc.: Employee, Salary. S. M. Bhavnani, Amplyx Pharmaceuticals, Inc.: Research Contractor, Research support. C. M. Rubino, Amplyx Pharmaceuticals, Inc.: Research Contractor, Research support.

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Miller, A. A., J. E. Herndon, D. R. Hollis, J. Ellerton, A. Langleben, F. Richards, and M. R. Green. "Schedule dependency of 21-day oral versus 3-day intravenous etoposide in combination with intravenous cisplatin in extensive-stage small-cell lung cancer: a randomized phase III study of the Cancer and Leukemia Group B." Journal of Clinical Oncology 13, no. 8 (August 1995): 1871–79. http://dx.doi.org/10.1200/jco.1995.13.8.1871.

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PURPOSE This was a randomized phase III study to test the schedule dependency of etoposide given as a conventional 3-day intravenous (IV) regimen versus a prolonged 21-day oral regimen for extensive-stage small-cell lung cancer (SCLC). Both regimens contained IV cisplatin. The objectives were to compare survival (primary end point) and to establish response rates, failure-free survival, and toxicity (secondary end points). PATIENTS AND METHODS Patients with untreated measurable or assessable disease and normal organ function were eligible. Randomization was stratified according to performance status 0 versus 1 or 2. Treatment consisted of etoposide 130 mg/m2/d IV for 3 days and cisplatin 25 mg/m2/d IV for 3 days every 21 days for eight courses (schedule 1) versus etoposide 50 mg/m2/d orally for 21 days and cisplatin 33 mg/m2/d IV for 3 days every 28 days for six courses (schedule 2). In 1990, bioavailability of oral etoposide was assumed to be 50%, and the study was designed to deliver the same total doses of etoposide and cisplatin on both regimens over 24 weeks without the use of growth factors. RESULTS Between December 1990 and October 1993, 306 eligible patients were entered. Of these, 69% were male and 66% were > or = 60 years of age; 21% had a performance status of 0, 47% a performance status of 1, and 32% a performance status of 2; 156 were randomized to receive schedule 1 and 150 to receive schedule 2. Overall median survival estimates were 9.5 and 9.9 months (difference not significant) for schedule 1 and schedule 2, respectively. The 95% confidence interval (CI) for overall survival, 8 to 11 months, was the same for both schedules, with 126 and 117 deaths on schedule 1 and 2, respectively. Both schedules also resulted in the same median failure-free survival estimate of 7 months (95% CI, 6 to 8 months on either schedule). Complete and partial responses were observed in 15% and 42% of patients on schedule 1 and 14% and 47% on schedule 2, respectively. The overall maximal hematologic toxicities grade 3 and 4 for leukocytes, neutrophils, platelets, and hemoglobin were, respectively, as follows: schedule 1, 62%, 85%, 32%, and 32%; schedule 2, 83%, 83%, 52%, and 53%. Lethal toxicity due to neutropenia and infection occurred in 4% of patients on schedule 1 and 10% on schedule 2 (difference not statistically significant). CONCLUSION The two schedules of etoposide in combination with cisplatin did not result in differences in treatment outcome with respect to tumor response and survival. However, a significantly greater rate of severe or life-threatening hematologic toxicity was noted on the 21-day oral etoposide treatment schedule.

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Seragel-Deen, Fatma, Seham A. Abdel Ghani, Houry M. Baghdadi, and Ali M. Saafan. "Combined Cisplatin Treatment and Photobiomodulation at High Fluence Induces Cytochrome c Release and Cytomorphologic Alterations in HEp-2 Cells." Open Access Macedonian Journal of Medical Sciences 8, A (May 15, 2020): 366–73. http://dx.doi.org/10.3889/oamjms.2020.4561.

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BACKGROUND: Photochemotherapy is thought to be a novel therapeutic modality for cancer. The photobiomodulation (PBM), applied through high fluence low-level laser irradiation (HF-LLLI), can be combined with the chemotherapeutic drug cisplatin to gain the benefit of potentiating its cytotoxic effect at possibly lower doses. AIM: The study aimed at investigation of the apoptotic effect of PBM, through LLLI (at HF), alone and in combination with cisplatin on cultured laryngeal cancer (HEp-2) cells. MATERIALS AND METHODS: In the current experimental in vitro research, cultured laryngeal cancer cell line (HEp-2) was treated with the half maximal inhibitory concentration of cisplatin, with and without LLLI. The study design consisted of four groups: Control (untreated), cisplatin-alone-treated, PBM-alone-treated, and combination cisplatin + PBM treated groups. Cells were irradiated once with diode laser (wavelength 808 nm, energy output 350 mW, 3 min, fluence 190.91 J/cm2, and continuous wave mode). Cytotoxicity was assessed by 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide assay and the potential apoptotic effect was evaluated by cytochrome c (CYC) release through enzyme-linked immunosorbent assay (ELISA), in conjunction with visualization of cytomorphologic alterations by light microscopic examination, followed by digital morphometric analysis of nuclear changes through estimation of nuclear area factor (NAF). Analysis of variance and post hoc multiple-comparison tests were used for statistical analysis of the data of cytotoxicity assay, ELISA, and nuclear morphometric analysis. RESULTS: PBM alone had a neutral effect on viability of HEp-2 cells, but it induced CYC release and lowered NAF mean value, significantly. When PBM was combined with cisplatin, more conspicuous deterioration in bioavailability of HEp-2 cells was observed, a higher amount of CYC was liberated and NAF value dropped in HEp-2 cells, compared to those which received separate treatments with cisplatin alone or PBM alone. CONCLUSION: Based on the current findings, low-level laser photochemotherapy might be a promising adjunctive anticancer treatment for laryngeal cancer, as PBM at HF was able to augment the apoptotic effect of cisplatin on HEp-2 cancer cells.

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Chan, Wenyaw. "Statistical Methods in Medical Research." Model Assisted Statistics and Applications 8, no. 2 (May 15, 2013): 83–84. http://dx.doi.org/10.3233/mas-130255.

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Gibbons, Robert R., Donald R. Hedeker, and Alexander von Eye. "Statistical Methods in Longitudinal Research:." Journal of the American Statistical Association 86, no. 416 (December 1991): 1146. http://dx.doi.org/10.2307/2290546.

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Armitage, P., and G. Berry. "Statistical Methods in Medical Research." Biometrics 53, no. 1 (March 1997): 391. http://dx.doi.org/10.2307/2533132.

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Satagopan, Jaya M., and Alex D. Smith. "Statistical Methods in Genomics Research." Heart Drug 3, no. 1 (2003): 48–60. http://dx.doi.org/10.1159/000070907.

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Wickham, Carol A. C., P. Armitage, and G. Berry. "Statistical Methods in Medical Research." Journal of the Royal Statistical Society. Series A (Statistics in Society) 151, no. 2 (1988): 361. http://dx.doi.org/10.2307/2982765.

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Simpson, Pippa M., John A. Spratt, and John S. Spratt. "Statistical methods in cancer research." Journal of Surgical Oncology 76, no. 3 (2001): 201–23. http://dx.doi.org/10.1002/jso.1035.

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Gardner, Bernard. "Statistical methods in cancer research." Journal of Surgical Oncology 78, no. 4 (2001): 281. http://dx.doi.org/10.1002/jso.1170.

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Newgard, Craig D., and Roger J. Lewis. "Statistical Methods for Prehospital Care Research." Prehospital Emergency Care 6, sup2 (January 2002): S9—S17. http://dx.doi.org/10.3109/10903120209102676.

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Wegner, Gail D. "Statistical Methods for Health Care Research." Journal of Gerontological Nursing 21, no. 7 (July 1, 1995): 52. http://dx.doi.org/10.3928/0098-9134-19950701-15.

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Sanchis, Juan, Pablo Avanzas, Antoni Bayes-Genis, Leopoldo Pérez de Isla, and Magda Heras. "New Statistical Methods in Cardiovascular Research." Revista Española de Cardiología (English Edition) 64, no. 6 (June 2011): 499–500. http://dx.doi.org/10.1016/j.rec.2011.01.016.

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Hagan, Paul, and Dymphna Fellowes. "Multivariate statistical methods in battery research." Journal of Power Sources 122, no. 1 (July 2003): 77–84. http://dx.doi.org/10.1016/s0378-7753(03)00344-6.

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Marzjarani, Morteza. "Statistical Methods in Social Science Research." Technometrics 62, no. 2 (April 2, 2020): 1–288. http://dx.doi.org/10.1080/00401706.2020.1744914.

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Akimova, O. V., and N. V. Zakharchenko. "THE STATISTICAL METHODS IN PEDAGOGICAL RESEARCH." Innovate Pedagogy 1, no. 20 (2020): 68–71. http://dx.doi.org/10.32843/2663-6085-2020-20-1-14.

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Johnson, Marsha. "Statistical Methods for Health Care Research." Gastroenterology Nursing 19, no. 4 (July 1996): 153. http://dx.doi.org/10.1097/00001610-199607000-00010.

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Schinka, John A., Leif LaLone, and Jo Ann Broeckel. "Statistical Methods in Personality Assessment Research." Journal of Personality Assessment 68, no. 3 (June 1997): 487–96. http://dx.doi.org/10.1207/s15327752jpa6803_2.

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Schober, Patrick, and Thomas R. Vetter. "Nonparametric Statistical Methods in Medical Research." Anesthesia & Analgesia 131, no. 6 (November 13, 2020): 1862–63. http://dx.doi.org/10.1213/ane.0000000000005101.

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Lovell, David. "Statistical methods for pharmaceutical research planning." Food and Chemical Toxicology 25, no. 11 (November 1987): 879. http://dx.doi.org/10.1016/0278-6915(87)90272-9.

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Vasovic, Velibor, Sasa Vukmirovic, Momir Mikov, Ivan Mikov, Zorana Budakov, Nebojsa Stilinovic, and Boris Milijasevic. "Influence of bile acid derivates on morphine analgesic effect in mice." Vojnosanitetski pregled 71, no. 8 (2014): 767–71. http://dx.doi.org/10.2298/vsp121010007v.

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Background/Aim. It is known that bile acids improve the absorption, bioavailability and pharmacodynamic characteristics of some drugs. Morphine analgesia is produced by activation of opioid receptors within the central nervous system (CNS) at both spinal and supraspinal levels. Since a morphine molecule contains 3 polar groups and therefore hard to transfer through the blood-brain barrier, the aim of the study was to examine the potential influence of bile acids derivates, namely sodium salt of monoketocholic acid (MKH-Na) and methyl ester of monoketocholic acid (MKH-Me), on analgesic effect of morphine. Methods. White male mice of NMRI-Haan strain, with body weight of 20-24 g, were used in this study. The analgesic effect of morphine (administered by subcutaneous and intramuscular route in a dose of 2 mg/kg), with and without pretreatment with MKH-Na (4 mg/kg) and MKH-Me (4 mg/kg) was estimated by the hot plate method. Results. Administration of MKH-Me prior to subcutaneous administration of morphine increased the morphine analgesic effect but the increase was not statistically significant. At the same time administration of MKH-Na did not affect morphine analgesic effect. The analgesic effect of morphine increased when administered intramuscularly 20 min after MKH-Me administration. When compared with the group of animals treated only with morphine, a statistically significant increase in analgesic effect was detected 10, 30, 40 and 50 min after morphine administration (p < 0.05). Pretreatment with MKH-Na did not affect morphine analgesic effect. Conclusion. According to the results of this study it can be presumed that after intramuscular morphine administration methyl ester of monoketocholic acid increases morphine transport into the central nervous system and consequently the analgesic effect, as well. Further research on bile acids-morphine interaction both in vitro and in vivo is necessary to completely elucidate the mechanism of this interaction and increase in the morphine analgesic effect.

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Bumbăcilă, Bogdan, and Mihai V. Putz. "Neurotoxicity of Pesticides: The Roadmap for the Cubic Mode of Action." Current Medicinal Chemistry 27, no. 1 (February 18, 2020): 54–77. http://dx.doi.org/10.2174/0929867326666190704142354.

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Pesticides are used today on a planetary-wide scale. The rising need for substances with this biological activity due to an increasing consumption of agricultural and animal products and to the development of urban areas makes the chemical industry to constantly investigate new molecules or to improve the physicochemical characteristics, increase the biological activities and improve the toxicity profiles of the already known ones. Molecular databases are increasingly accessible for in vitro and in vivo bioavailability studies. In this context, structure-activity studies, by their in silico - in cerebro methods, are used to precede in vitro and in vivo studies in plants and experimental animals because they can indicate trends by statistical methods or biological activity models expressed as mathematical equations or graphical correlations, so a direction of study can be developed or another can be abandoned, saving financial resources, time and laboratory animals. Following this line of research the present paper reviews the Structure-Activity Relationship (SAR) studies and proposes a correlation between a topological connectivity index and the biological activity or toxicity made as a result of a study performed on 11 molecules of organophosphate compounds, randomly chosen, with a basic structure including a Phosphorus atom double bounded to an Oxygen atom or to a Sulfur one and having three other simple covalent bonds with two alkoxy (-methoxy or -ethoxy) groups and to another functional group different from the alkoxy groups. The molecules were packed on a cubic structure consisting of three adjacent cubes, respecting a principle of topological efficiency, that of occupying a minimal space in that cubic structure, a method that was called the Clef Method. The central topological index selected for correlation was the Wiener index, since it was possible this way to discuss different adjacencies between the nodes in the graphs corresponding to the organophosphate compounds molecules packed on the cubic structure; accordingly, "three dimensional" variants of these connectivity indices could be considered and further used for studying the qualitative-quantitative relationships for the specific molecule-enzyme interaction complexes, including correlation between the Wiener weights (nodal specific contributions to the total Wiener index of the molecular graph) and the biochemical reactivity of some of the atoms. Finally, when passing from SAR to Q(uantitative)-SAR studies, especially by the present advanced method of the cubic molecule (Clef Method) and its good assessment of the (neuro)toxicity of the studied molecules and of their inhibitory effect on the target enzyme - acetylcholinesterase, it can be seen that a predictability of the toxicity and activity of different analogue compounds can be ensured, facilitating the in vivo experiments or improving the usage of pesticides.

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Shukla, Arvind Kumar, Sartaj Ahmad, Saurabh Sharma, Amit Mohan Varsheny, Anuradha Davey, Pawan Parashar, and Bhawana Pant. "Utilization of Statistical Methods in Microbiological Research." International Journal of Contemporary Microbiology 1, no. 1 (2015): 126. http://dx.doi.org/10.5958/2395-1796.2015.00028.9.

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Jacob, KS. "Statistical Methods in Psychiatric Research and SPSS." Indian Journal of Psychiatry 58, no. 3 (2016): 356. http://dx.doi.org/10.4103/0019-5545.192008.

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Chalmers, Colin, and P. V. Rao. "Statistical Research Methods in the Life Sciences." Mathematical Gazette 83, no. 498 (November 1999): 569. http://dx.doi.org/10.2307/3621027.

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Derringer, George C. "Statistical Methods in Rubber Research and Development." Rubber Chemistry and Technology 61, no. 3 (July 1, 1988): 377–421. http://dx.doi.org/10.5254/1.3536194.

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Abstract As this article has demonstrated, statistical methods have considerable utility in rubber research and development. Such methods are cost effective and perhaps, more important, help the user to formulate questions in such a way as to make research programs more productive. The use of statistical methods in formulation development have been particularly fruitful. For example, without statistical methods, the compounders common task of simultaneously achieving a specific balance of cost, property levels, and processing behavior would be an expensive undertaking at best and hopeless at worst. Statistical methods help the practitioner make sound decisions in the light of often extreme variability in the data. This is especially the case when the data is fatigue, tensile strength, or some other fracture property of rubber. In the light of such broad distributions, hit or miss and one variable at a time strategies are seriously flawed. It is not hard to find a sequential study in which decisions about each trial were driven simply by changes due to random variability which were erroneously attributed to the intentional changes in variable level(s) from the previous trial. Such research studies are very similar to random walks. Many excellent and innovative studies are reported above. However, given the wide utility of statistical methods, these methods appear to be underutilized judging from the unexpectedly small number of papers which were found. Similarly, it is not difficult to find published rubber research which would not have benefitted by the use of statistical experimental design and/or data analysis. Fortunately, however, this appears to be changing. The increasing availability of good affordable software for personal computers makes it possible for good statistics to be done with less dependence on trained statisticians which are not available in many organizations. As this trend continues, the number of studies employing statistical methods will surely grow.

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Topchishvili, Alexander, and Stan Lipovetsky. "Statistical methods in optimization and operations research." Model Assisted Statistics and Applications 6, no. 3 (August 26, 2011): 161–62. http://dx.doi.org/10.3233/mas-2011-0202.

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GORE, W. L. "STATISTICAL METHODS IN PLASTICS RESEARCH AND DEVELOPMENT." Quality Engineering 2, no. 1 (January 1989): 81–89. http://dx.doi.org/10.1080/08982118908962699.

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Stapleton, John, Robert West, John Marsden, and Wayne Hall. "Research methods and statistical techniques in addiction." Addiction 107, no. 10 (September 10, 2012): 1724–25. http://dx.doi.org/10.1111/j.1360-0443.2012.03969.x.

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Heath, Andrew C., Pamela AF Madden, and Nicholas G. Martin. "Statistical methods in genetic research on smoking." Statistical Methods in Medical Research 7, no. 2 (April 1998): 165–86. http://dx.doi.org/10.1177/096228029800700205.

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Ferrão, Maria Eugénia. "Statistical Methods in Recent Higher Education Research." Journal of College Student Development 61, no. 3 (2020): 366–71. http://dx.doi.org/10.1353/csd.2020.0033.

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Heath, A. C., P. A. M. Madden, and N. G. Martin. "Statistical methods in genetic research on smoking." Statistical Methods in Medical Research 7, no. 2 (February 1, 1998): 165–86. http://dx.doi.org/10.1191/096228098676685170.

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Purdie, D. "Statistical Methods in Medical Research, 4th edn." Internal Medicine Journal 33, no. 1-2 (January 2003): 67. http://dx.doi.org/10.1046/j.1445-5994.2002.00319.x.

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Pande, Hemlata, and H. S. Dhami. "Statistical Methods in Language and Linguistic Research." Journal of Quantitative Linguistics 21, no. 3 (June 17, 2014): 295–97. http://dx.doi.org/10.1080/09296174.2014.911507.

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Farnum, Nicholas R. "Statistical Methods." Journal of Quality Technology 22, no. 3 (July 1990): 252–53. http://dx.doi.org/10.1080/00224065.1990.11979254.

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