Relevant bibliographies by topics / FDA-approved drug

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'FDA-approved drug'

Author: Grafiati
Published: 6 September 2023

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Journal articles on the topic "FDA-approved drug"

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Gould, Stephen J. "AIDS and FDA Drug-Approved Policy:." Journal of Health & Social Policy 2, no. 2 (February 21, 1991): 39–46. http://dx.doi.org/10.1300/j045v02n02_03.

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Vokinger, Kerstin Noëlle, and Aaron S. Kesselheim. "Application of orphan drug designation to cancer treatments (2008–2017): a comprehensive and comparative analysis of the USA and EU." BMJ Open 9, no. 10 (October 2019): e028634. http://dx.doi.org/10.1136/bmjopen-2018-028634.

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ObjectiveTo determine differences in the characteristics of cancer drugs designated as orphan drugs by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).Design and settingIdentification of all cancer drugs (initial or supplementary indication) with orphan status approved by the FDA between 2008–2017 based on publicly accessible reports. The European public assessment reports (EPAR) was searched to determine whether these FDA-approved drugs were also approved by the EMA.Main outcome measuresExtraction of active ingredient, trade name, approval date and approved indication from two FDA data sources (Orphan Drug Product Designation Database, Drugs@FDA) and comparison with the same data from EPAR.ResultsThe FDA approved 135 cancer drugs with orphan indications that met our inclusion criteria, of which 101 (75%) were also approved by the EMA. 80/101 (79%) were first approved in the USA. Only 41/101 (41%) also received orphan designation by the EMA. 33/101 (33%) were approved for biomarker-based indications in the USA, however, only nine approved cancer drug indications by the EMA were biomarker-derived drugs. 78% (47/60) of approved cancer drugs that were only approved in the USA with orphan status were indicated for solid tumours, 22% (13/60) had indications for non-solid tumours. By contrast, out of those approved cancer drugs that received orphan designation by both agencies, 20% (8/41) were indicated for solid, and 80% (33/41) for non-solid tumours.ConclusionsOrphan designation was intended to encourage drug development for rare conditions. This study shows that the FDA approves more cancer drugs with such designations compared with the EMA, especially for subgroups of more prevalent cancers. One reason for the difference could be that the European Union requires demonstration of significant benefit for drugs that target the same indication as a drug already on the market to earn the orphan designation.
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Zhong, Hao, Ging Chan, Yuanjia Hu, Hao Hu, and Defang Ouyang. "A Comprehensive Map of FDA-Approved Pharmaceutical Products." Pharmaceutics 10, no. 4 (December 6, 2018): 263. http://dx.doi.org/10.3390/pharmaceutics10040263.

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With the increasing research and development (R&D) difficulty of new molecular entities (NMEs), novel drug delivery systems (DDSs) are attracting widespread attention. This review investigated the current distribution of Food and Drug Administration (FDA)-approved pharmaceutical products and evaluated the technical barrier for the entry of generic drugs and highlighted the success and failure of advanced drug delivery systems. According to the ratio of generic to new drugs and the four-quadrant classification scheme for evaluating the commercialization potential of DDSs, the results showed that the traditional dosage forms (e.g., conventional tablets, capsules and injections) with a lower technology barrier were easier to reproduce, while advanced drug delivery systems (e.g., inhalations and nanomedicines) with highly technical barriers had less competition and greater market potential. Our study provides a comprehensive insight into FDA-approved products and deep analysis of the technical barriers for advanced drug delivery systems. In the future, the R&D of new molecular entities may combine advanced delivery technologies to make drug candidates into more therapeutically effective formulations.
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Ezeife, Doreen Anuli, Patricia Tang, Daniel Yick Chin Heng, and Stephen Welch. "Comparison of drug approval between health Canada (HC) and the U.S. Food and Drug Administration (FDA)." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 6082. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.6082.

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6082 Background: Differences in drug approval processes between countries can impact patient access to new therapies. In Canada, patients can freely access a new treatment after regulatory approval by Health Canada (HC) followed by funding approval from the provincial government. The aims of this study were to delineate the Canadian drug approval timeline and to compare the time to drug approval between HC and the US FDA. Methods: Cancer drugs approved by the FDA from 1989 to 2011 were reviewed. For each drug, the following endpoints were determined: publication date of phase I and pivotal phase III trial, date of FDA and HC approval, HC submission date, and funding approval in Alberta (AB). Time intervals between the aforementioned endpoints were calculated. Results: Of 55 FDA-approved drugs, 51 drugs are approved by HC with 40 of these drugs funded in AB. HC approval occurs an average of 14.4 months post FDA approval (95% CI -36.9 to 66.1, sign rank test p<0.0001). However, there was no significant difference between the mean time from Phase I to FDA approval (48.5 months; 95% CI 21.2 to 75.8) and Phase I to HC approval (61.5 months; 95% CI 32.4 to 90.5). Most drugs (74%) were approved by the FDA prior to publication of the phase III trial. There was a trend towards faster drug approval from Phase III to FDA approval compared to HC (-14.97 versus 0.1 months, p = 0.05). HC submission occurs before FDA drug approval 77% of the time (mean 3.0 months prior; 95%CI: -59.1 to 43.4, p = 0.0206). HC approval occurs on average 17 months post HC submission. AB funding approval occurs on average 22 months after HC approval. The time interval from Phase I to AB funding approval was significantly shorter for targeted compared to cytotoxic agents (mean time 58 vs. 120 months; p = 0.039). Conclusions: HC drug approval lags behind FDA approval by about 14 months. Time from Phase III to drug approval tends to be shorter for the FDA compared to HC. This is the first documentation, to our knowledge, of the time required to bring a drug from phase I trial to provincial funding approval.
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Saberian, Nafiseh, Azam Peyvandipour, Michele Donato, Sahar Ansari, and Sorin Draghici. "A new computational drug repurposing method using established disease–drug pair knowledge." Bioinformatics 35, no. 19 (March 6, 2019): 3672–78. http://dx.doi.org/10.1093/bioinformatics/btz156.

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Abstract Motivation Drug repurposing is a potential alternative to the classical drug discovery pipeline. Repurposing involves finding novel indications for already approved drugs. In this work, we present a novel machine learning-based method for drug repurposing. This method explores the anti-similarity between drugs and a disease to uncover new uses for the drugs. More specifically, our proposed method takes into account three sources of information: (i) large-scale gene expression profiles corresponding to human cell lines treated with small molecules, (ii) gene expression profile of a human disease and (iii) the known relationship between Food and Drug Administration (FDA)-approved drugs and diseases. Using these data, our proposed method learns a similarity metric through a supervised machine learning-based algorithm such that a disease and its associated FDA-approved drugs have smaller distance than the other disease-drug pairs. Results We validated our framework by showing that the proposed method incorporating distance metric learning technique can retrieve FDA-approved drugs for their approved indications. Once validated, we used our approach to identify a few strong candidates for repurposing. Availability and implementation The R scripts are available on demand from the authors. Supplementary information Supplementary data are available at Bioinformatics online.
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Hershman, Dawn L., Alfred I. Neugut, Donna Buono, Catherine A. Richards, Sherry A. Glied, and Jason Dennis Wright. "Off-label and compendia use of chemotherapy in patients with metastatic cancer." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 6509. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.6509.

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6509 Background: In 2012, ASCO Identified opportunities to improve the quality and value of cancer care by reducing inappropriate and/or prolonged use of chemotherapy The NCCN compendium is recognized as an authoritative reference for insurance coverage for drug indications without FDA approval. We evaluated FDA-approved, compendia and unapproved use of chemotherapy. Methods: We useddata from the SEER-Medicare database to identify patients with metastatic cancer who received chemotherapy. For each tumor, drugs with >3 claims were identified. Each drug was classified as having an FDA-approved indication, an indication based on NCCN compendia guidelines or neither of these. The number of claims for each drug was calculated. Logistic regression was used to assess the factors that Results: Between 1998-2007, 37,351 subjects were identified as having received chemotherapy; of these, 24,876 (66.6%) received only FDA approved drugs, and 12,475 (33.4%) received at least one unapproved drug. Of those who received an unapproved drug, 8,669 (69%) received a drug with a compendia listing. Therefore, of the total population, 10% received a drug that was neither FDA nor compendia approved. The mean number of unapproved claims was 10.3 (SD=15.2) and the mean number of drugs was 1.3. Unapproved use was highest in subjects with prostate and lowest in patients with colon cancer. In a multivariate analysis, unapproved use decreased with increasing age and >2 comorbid conditions. Compared to prostate cancer, the odds of having an unapproved drug was lower for breast (OR=0.27), colon (OR=0.08), lung (OR=0.65), ovary (OR=0.38), uterus (OR=0.49) and myeloma (OR=0.60). No patients with colon or prostate cancer received compendia-approved drugs. Over 90% of unapproved use for breast, ovary and lung cancer were compendia-approved. Costs associated with unapproved/compendia use will be presented. Conclusions: A large fraction of patients who use chemotherapy receive FDA-unapproved drugs; however, the majority of those drugs are acknowledged by NCCN. A better understanding of the costs and benefits of compendia-approved drugs is warranted to reduce the costs of cancer care.
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Nair, Aathira Sujathan, Ashutosh Kumar Singh, Astik Kumar, Sunil Kumar, Sunitha Sukumaran, Vishal Payyalot Koyiparambath, Leena K. Pappachen, T. M. Rangarajan, Hoon Kim, and Bijo Mathew. "FDA-Approved Trifluoromethyl Group-Containing Drugs: A Review of 20 Years." Processes 10, no. 10 (October 11, 2022): 2054. http://dx.doi.org/10.3390/pr10102054.

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As people around the world regard 2020 as the year of COVID-19, the medical community considers this year to be the second-best year, shared with the year 1996, with respect to the number of drug molecules approved by the US Food and Drug Administration (FDA). Both years, 2020 and 1996, had a record of 53 new drug molecules approved by the FDA. In the year 2020, 53 new chemical entities and 13 biological medicines were approved, including 10 monoclonal antibodies, 2 antibody-drug conjugates, 3 peptides, and 2 oligonucleotides. Among them, most of the compounds were found to have fluorine or fluorine-containing functional groups exhibiting numerous pharmacological activities. Herein, we summarized the trifluoromethyl (TFM, -CF3)-group-containing FDA-approved drugs for the last 20 years. This article specially features and details the previous 20-year literature data, covering CF3-incorporated potential drug molecules, including their syntheses and uses for various diseases and disorders. The review covers the detailed chemistry of 19 FDA-approved drugs in the past 20 years, which contains the TFM group as one of the pharmacophores.
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Klasmeier, Coleen, and Martin H. Redish. "Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection." American Journal of Law & Medicine 37, no. 2-3 (June 2011): 315–57. http://dx.doi.org/10.1177/009885881103700206.

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In order to protect the nation from harmful or worthless drugs and devices, the Food and Drug Administration (FDA or the Agency) is legislatively authorized to restrict the sale of prescription drugs or medical devices to those whose efficacy and safety have been reviewed and approved by the Agency. Drugs and devices are approved for a specific medical purpose. In numerous instances, however, the medical profession has discovered that treatments approved for one purpose may also serve other valuable medical purposes. Indeed, on a number of occasions such “off-label” treatments have proven to be essential to the successful treatment of some very serious illnesses.In these off-label situations, the FDA is faced with a dilemma. On the one hand, off-label use of prescription drug and devices gives rise to a series of major problems for the FDA. While the drug and devices in question have been vetted and approved by the FDA for their designated purpose, at no point has the FDA reviewed the supporting scientific data to determine efficacy for the off-label purpose.
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Losben, Nancy L. "2020: A Record Year for Drug Approvals." Senior Care Pharmacist 36, no. 4 (April 1, 2021): 174–75. http://dx.doi.org/10.4140/tcp.n.2021.174.

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In 2020 The United States Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) approved 53 novel drugs, five more than in 2019, but still an aggressive number when compared with 2015 when only 45 new drugs were released to the market. CDER, the largest department within the FDA, has robustly approved a rising number of generic drugs in the last several years, increasing their accessibility and reducing patient and payor costs.
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Rizzo, Carla, Sara Amata, Ivana Pibiri, Andrea Pace, Silvestre Buscemi, and Antonio Palumbo Piccionello. "FDA-Approved Fluorinated Heterocyclic Drugs from 2016 to 2022." International Journal of Molecular Sciences 24, no. 9 (April 23, 2023): 7728. http://dx.doi.org/10.3390/ijms24097728.

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The inclusion of fluorine atoms or heterocyclic moiety into drug structures represents a recurrent motif in medicinal chemistry. The combination of these two features is constantly appearing in new molecular entities with various biological activities. This is demonstrated by the increasing number of newly synthesized fluorinated heterocyclic compounds among the Food and Drug Administration FDA-approved drugs. In this review, the biological activity, as well as the synthetic aspects, of 33 recently FDA-approved fluorinated heterocyclic drugs from 2016 to 2022 are highlighted.
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Dissertations / Theses on the topic "FDA-approved drug"

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MASSARO, DAMIANO SERGIO. "Drug Reprofile for Friedreich’s Ataxia: Screening of an FDA-Approved Drugs Library searching for small molecules that increase Frataxin." Doctoral thesis, Università degli Studi di Roma "Tor Vergata", 2015. http://hdl.handle.net/2108/203080.

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Freidreich’s Ataxia (FRDA) is a neurodegenerative, autosomal hereditary disease characterized by progressive neurodegeneration, cardiomyopathy and increased incidence of diabetes. The disease is caused by a trinucleotide GAA repeat expansion within the first intron of the gene coding for frataxin protein (FXN). Pathological GAA expansion (from ~70 to >1,000 triplets) results in “sticky” DNA structures and epigenetic changes that severely reduce transcription of the gene. FRDA patients live with 10-30% residual frataxin. The severity of the disease is proportionally related to the number of GAA triplets, which in turn correlates to the reduction in frataxin levels. Sensory neurons in dorsal root ganglia (DRG) are particularly involved and damaged by inflammatory condition derived from frataxin deficiency. Currently there is no approved and specific therapy for FRDA able to increase the protein deficient in this disease. Here we propose a drug repositioning approach looking for a new application of known drugs in this pathology. A significant advantage of drug repositioning over traditional drug development is that since the repositioned drug has already passed a significant number of trials, its safety is known and the risk of failure for reasons of adverse toxicology are reduced. Therefore, drug repositioning represents an attractive approach to identify a new therapy for Friedreich ataxia.
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Capua, Christopher James. "Comparative Cytotoxicity of an FDA-approved Cancer Drug to Extracts of Atriplex confertifolia on Human Breast and Cervical Cancer Cells." BYU ScholarsArchive, 2008. https://scholarsarchive.byu.edu/etd/1703.

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The severity and number of people affected by cancer is a worldwide problem with millions of people affected annually. The search for treatment and cures of cancer continues to be a global effort. As part of this global effort, many natural products have been tested against cancer cell lines, most from plants located in tropical regions. However, this study reports that extracts of Atriplex confertifolia, a native North American plant, has significant bioactivity against human breast cancer cell lines MCF-7, 435, and 231, and HeLa cells (cervical cancer cells). The bioactivity of A. confertifolia extracts of these cells lines was compared to an FDA-approved cancer drug and an industry-standard leukocyte control cell line. Active portions of the extracts were found primarily in the polar fractions of the plant. A dose-response curve of the extracts clearly showed significant cell death similar to the FDA-approved drug. The plant extracts did not inhibit the viability of the leukocyte cell line. Cancer cell death was followed as a function of time and concentration. Cell death appears to be a result of apoptosis.
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Péladeau, Christine. "Utrophin A Upregulation by FDA-Approved Drugs for the Treatment of Duchenne Muscular Dystrophy." Thesis, Université d'Ottawa / University of Ottawa, 2019. http://hdl.handle.net/10393/39298.

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Duchenne Muscular Dystrophy (DMD) is a disorder caused by mutations in the dystrophin gene, preventing the production of the functional dystrophin protein which assures maintenance of the myofiber integrity throughout muscle contraction. A lack of dystrophin results in severe muscle degeneration and regeneration accompanied by a loss of muscle function. Many pre-clinical and clinical studies are focused on developing strategies to counteract the detrimental effects of DMD; however, there is no cure. One such approach consists of upregulating the endogenous protein utrophin A in dystrophic muscle, which, once highly expressed at the sarcolemma, could functionally compensate for the lack of dystrophin. Recent evidence demonstrates that utrophin A expression is regulated at its 3’ and 5’UTR through post-transcriptional and translational events. Therefore, in the work presented here, we hypothesized that repurposing FDA-approved drugs that target the signaling pathways involved in post-transcriptional and translational regulation of utrophin A will be an efficient approach in rapidly bringing new therapeutic interventions for DMD. In this work, we repurposed four promising FDA-approved drugs able to stimulate utrophin A expression levels in dystrophic muscles: the anti-coagulant drug Heparin, the anti-inflammatory drug Celecoxib, the β-adrenergic receptor blocking agent Betaxolol and the cholesterol-lowering drug Pravastatin. These drugs induce significant improvements in the dystrophic phenotype of mdx mice. This includes amelioration of muscle fiber integrity and muscle function as well as promoting morphological and fiber type changes in mdx mice muscles. Collectively, this thesis describes the potential of a repurposing approach to activate key post-transcriptional and translational pathways involved in utrophin A’s regulation in the hopes of developing new therapeutics for the treatment of DMD.
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Alqahtani, Saad Mohammed S. "Molecular Determinants for Binding of the FDA-Approved Drugs in Proteins – A Data Mining and Advanced Quantum Chemical Study." University of Toledo / OhioLINK, 2017. http://rave.ohiolink.edu/etdc/view?acc_num=toledo1493378726116385.

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Fan, Ya-Wen, and 范雅雯. "The effect and molecular action of curcumin in FDA-approved clinical drug-treated human bladder cancer cells." Thesis, 2014. http://ndltd.ncl.edu.tw/handle/63474138092702105330.

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碩士
國立臺灣師範大學
人類發展與家庭學系
102
Bladder cancer is the ninth most common cancer worldwide and the fourteenth most diagnosed malignancy in Taiwan (2013). Gemcitabine plus cisplatin (GC) treatment is prefered for nowadays treatment. For patients with impaired renal function, gemcitabine plus carboplatin (GCa) treatment is recommended. Overexpressions of Aurora A kinase and epidermal growth factor (EGF) were observed in bladder cancer cells. Our previously data demonstrate that curcumin significantly inhibited Aurora A gene expression, in part caused failure of various mitotic events and G2/M arrest of human bladder cancer cells. In this study, human bladder cancer T24 cells were treated with the existing chemotherapy (GC or GCa) in the presence and absence of curcumin. Addition of curcumin not only produced synergism using combination index analysis, but also raised the percentages of phases in sub-G1 (apoptosis rate) and G2/M using flow cytometry. Combinatio of cucurmin induced autophagy. Decreasing of phospho-Aurora A, p62, Beclin-1, phospho-PI3K, phospho-p70s6k, Atg12-Atg5 and increasing of LC3-II, phospho-mTOR, phospho-AKT, phospho-MEK, phospho-ERK were observed. Taken together, clinical drugs combined with curcumin not only inhibited activity of aurora a, but also promoted apoptosis and autophagy in T24 cells.
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(8803004), Logan C. Ganzen. "Drug Screening Utilizing the Visual Motor Response of a Zebrafish Model of Retinitis Pigmentosa." Thesis, 2020.

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Retinitis Pigmentosa (RP) is an incurable inherited retinal degeneration affecting approximately 1 in 4,000 individuals globally. The aim of this dissertation was to identify drugs that can help patients suffering from the disease. To accomplish this goal, the zebrafish was utilized as a model for RP to perform in vivo drug screening. The zebrafish RP model expresses a human rhodopsin transgene which contains a premature stop codon at position 344 (Tg(rho:Hsa.RH1_Q344X)). This zebrafish model exhibits significant rod photoreceptor degeneration beginning at 7 days post fertilization (dpf). To assess the visual consequence of this rod degeneration the zebrafish behavior visual motor response (VMR) was assayed under scotopic conditions. The Q344X RP model larvae displayed a deficit in this VMR in response to a scotopic light offset. This deficit in behavior was utilized to perform a drug screen to identify compounds that could ameliorate the deficient Q344X VMR. The ENZO SCREEN-WELL® REDOX library was chosen to be screened since oxidative stress may increase RP progression in a non-specific manner. From this library, a β-blocker, carvedilol, was identified as a compound that improved the Q344X VMR behavior. This drug was also able to increase rod number in the Q344X retina. Carvedilol was shown to be capable of working directly on rods by demonstrating that the drug can signal through the adrenergic pathway in the rod-like human Y79 cell line. Since carvedilol is an FDA-approved drug, this screening paradigm was utilized to screen the Selleckchem FDA-approved library to identify more drugs that can potentially be repurposed to treat RP like carvedilol. Additionally, this scotopic VMR assay was used to demonstrate that it can identify behavioral deficits in the P23H RP model zebrafish (Tg(rho:Hsa.RH1_P23H)). This dissertation work provides a potential FDA-approved drug for RP treatment and sets the foundation for future drug screening to identify more drugs to treat different forms of RP.
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Chang, En-Kai, and 張恩愷. "Combinatorial effects of six FDA approved drugs on influenza virus." Thesis, 2018. http://ndltd.ncl.edu.tw/handle/3272nt.

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碩士
國立陽明大學
微生物及免疫學研究所
106
英文摘要 Influenza virus belongs to Orthomyxoviridae. Influenza spreads around the world yearly, resulting in about three to five million cases of severe illness and about 250,000 to 500,000 deaths. The only drugs currently available to treat influenza are neuraminidase ( NA ) inhibitors,including oseltamivir ( Tamiflu ), zanamivir and peramivir, and an RNA-dependent RNA polymerase ( RdRp ) inhibitor, favipiravir ( Avigan ). Since influenza virus RdRp lacks proofreading activity, the genome is easy to mutate when replicating. As a result, drug resistance and limited vaccine protection occur. In this project, we hope to repurpose FDA-proved drugs for treating influenza. As to all viruses, influenza virus depends heavily on cellular mechanism to complete its life cycle. If inhibited cellular factors mediate the antiviral effects ( cellular factor-targeting ), drug-resistant influenza viruses may not be selected easily by cellular factor-targeting drugs as compared to virus-targeting drugs. Previously our lab used RdRp reporter assay to screen drugs, and found six drugs may inhibit influenza virus infection. All six drugs are generic drugs. Here I looked for combinations with synergistic anti-viral effects even at low drug dosages. A lower drug dosage will assert lower selection pressure on influenza virus and less cytotoxicity on host. In addition, treatment with multiple drugs decrease the possibility of drug-resistant viruses. First, the CC50 and IC50 of each of these six drugs were determind on MDCK and influenza-infected MDCK cells, respectively. Therapeutic index for each compound was calculated. Four out of six drugs tested were found to inhibit influenza virus replication by itself. Next, all of the binary and ternary combinations were tested, which concluded that a particular binary combination is most effective. In order to identify the likely steps suppressed by this combination, I added the drug combination at different time points post infection in time course assays and found that combination inhibited at early stage of the infection cycle. The results of hemagglutinin assay excluded that the combination inhibited HA protein binding to its receptor. Instead, the preliminary results supported that the combination acts on the step prior to viral RNP into cell nucleus. Testing the anti-viral ability of the combination on an animal model will further demonstrate its efficacy and potential in the future.
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"Lead Identification, Optimization and Characterization of Novel Cancer Treatment Strategies Using Repositioned Drugs." Doctoral diss., 2013. http://hdl.handle.net/2286/R.I.18035.

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abstract: Cancer is the second leading cause of death in the United States and novel methods of treating advanced malignancies are of high importance. Of these deaths, prostate cancer and breast cancer are the second most fatal carcinomas in men and women respectively, while pancreatic cancer is the fourth most fatal in both men and women. Developing new drugs for the treatment of cancer is both a slow and expensive process. It is estimated that it takes an average of 15 years and an expense of $800 million to bring a single new drug to the market. However, it is also estimated that nearly 40% of that cost could be avoided by finding alternative uses for drugs that have already been approved by the Food and Drug Administration (FDA). The research presented in this document describes the testing, identification, and mechanistic evaluation of novel methods for treating many human carcinomas using drugs previously approved by the FDA. A tissue culture plate-based screening of FDA approved drugs will identify compounds that can be used in combination with the protein TRAIL to induce apoptosis selectively in cancer cells. Identified leads will next be optimized using high-throughput microfluidic devices to determine the most effective treatment conditions. Finally, a rigorous mechanistic analysis will be conducted to understand how the FDA-approved drug mitoxantrone, sensitizes cancer cells to TRAIL-mediated apoptosis.
Dissertation/Thesis
Ph.D. Chemical Engineering 2013
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Wu, Chi-Shiuan, and 吳奇軒. "The role of KRAS gene in combination treatment of Curcumin and FDA-approved Targeted Drugs in human colorectal cancer cells." Thesis, 2016. http://ndltd.ncl.edu.tw/handle/69752446398460271062.

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Books on the topic "FDA-approved drug"

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United States. Food and Drug Administration, ed. FDA Approved Animal Drug Products, 1998. [S.l: s.n., 1998.

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United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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R, Loughlin Kevin, and Generali Joyce A, eds. The guide to off-label prescription drugs: New uses for FDA-approved prescription drugs. New York: Free Press, 2006.

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Meridia: The weight-loss breakthrough : everything you need to know about the FDA-approved weight-loss pill. Rocklin, CA: Prima Health, 1998.

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United States. Dept. of Defense. Office of the Secretary of Defense. and National Defense Research Institute (U.S.), eds. Military use of drugs not yet approved by the FDA for CW/BW defense: Lessons from the Gulf War. Santa Monica, CA: RAND, 1999.

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Courtney, Charles H. Veterinary antiparasitic drugs 1991: A comprehensive compendium of FDA-approved antiparasitic drugs. Gainesville, Fla: Institute of Food and Agricultural Sciences, University of Florida, 1991.

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United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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United States. Food and Drug Administration. Office of Public Affairs, ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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Book chapters on the topic "FDA-approved drug"

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Rehman, Nahid, and Anjana Pandey. "Nanomedicine Approved by FDA and EMEA." In Engineered Nanoparticles as Drug Delivery Systems, 79–90. Boca Raton: CRC Press, 2022. http://dx.doi.org/10.1201/9781003252122-8.

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Hassan, Mubashir, Saba Shahzadi, and Andrzej Kloczkowski. "Pharmacoinformatic Analysis of Drug Leads for Alzheimer’s Disease from FDA-Approved Dataset Through Drug Repositioning Studies." In Bioinformatics and Biomedical Engineering, 191–201. Cham: Springer Nature Switzerland, 2023. http://dx.doi.org/10.1007/978-3-031-34953-9_15.

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Barenholz, Yechezkel (Chezy). "Chapter 13. Doxil® – the First FDA-approved Nano-drug: from Basics via CMC, Cell Culture and Animal Studies to Clinical Use." In Drug Discovery, 315–45. Cambridge: Royal Society of Chemistry, 2016. http://dx.doi.org/10.1039/9781782622536-00315.

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Mitra, Debanjan, and Pradeep K. Das Mohapatra. "Computational Intelligence in Identification of Some FDA Approved Drug Compounds for Treatment of COVID-19." In Artificial Intelligence and Machine Learning Methods in COVID-19 and Related Health Diseases, 109–22. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-031-04597-4_5.

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Gan, Julian, Jong Hyun Cho, Ryan Lee, Alireza Naghizadeh, Ling Yue Poon, Ethan Wang, Zachary Hui, and Dongfang Liu. "Methods of Machine Learning-Based Chimeric Antigen Receptor Immunological Synapse Quality Quantification." In The Immune Synapse, 493–502. New York, NY: Springer US, 2023. http://dx.doi.org/10.1007/978-1-0716-3135-5_32.

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AbstractChimeric Antigen Receptor (CAR)-mediated immunotherapy shows promising results for refractory blood cancers. Currently, six CAR-T drugs have been approved by U.S. Food and Drug Administration (FDA). Theoretically, CAR-T cells must form an effective immunological synapse (IS, an interface between effective cells and their target cells) with their susceptible tumor cells to eliminate tumor cells. Previous studies show that CAR IS quality can be used as a predictive functional biomarker for CAR-T immunotherapies. However, quantification of CAR-T IS quality is clinically challenging. Machine learning (ML)-based CAR-T IS quality quantification has been proposed previously.Here, we show an easy-to-use, step-by-step approach to predicting the efficacy of CAR-modified cells using ML-based CARIS quality quantification. This approach will guide the users on how to use ML-based CARIS quality quantification in detail, which include: how to image CARIS on the glass-supported planar lipid bilayer, how to define the CARIS focal plane, how to segment the CARIS images, and how to quantify the IS quality using ML-based algorithms.This approach will significantly enhance the accuracy and proficiency of CARIS prediction in research.
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Kim, Hahnsung, Yin Wu, Daisy Villano, Dario Livio Longo, Michael T. McMahon, and Phillip Zhe Sun. "Analysis Protocol for the Quantification of Renal pH Using Chemical Exchange Saturation Transfer (CEST) MRI." In Methods in Molecular Biology, 667–88. New York, NY: Springer US, 2021. http://dx.doi.org/10.1007/978-1-0716-0978-1_40.

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AbstractThe kidney plays a major role in maintaining body pH homeostasis. Renal pH, in particular, changes immediately following injuries such as intoxication and ischemia, making pH an early biomarker for kidney injury before the symptom onset and complementary to well-established laboratory tests. Because of this, it is imperative to develop minimally invasive renal pH imaging exams and test pH as a new diagnostic biomarker in animal models of kidney injury before clinical translation. Briefly, iodinated contrast agents approved by the US Food and Drug Administration (FDA) for computed tomography (CT) have demonstrated promise as novel chemical exchange saturation transfer (CEST) MRI agents for pH-sensitive imaging. The generalized ratiometric iopamidol CEST MRI analysis enables concentration-independent pH measurement, which simplifies in vivo renal pH mapping. This chapter describes quantitative CEST MRI analysis for preclinical renal pH mapping, and their application in rodents, including normal conditions and acute kidney injury.This publication is based upon work from the COST Action PARENCHIMA, a community-driven network funded by the European Cooperation in Science and Technology (COST) program of the European Union, which aims to improve the reproducibility and standardization of renal MRI biomarkers. This analysis protocol chapter is complemented by two separate chapters describing the basic concepts and experimental procedure.
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Scott, Kevin A., and Jon T. Njardarson. "Analysis of US FDA-Approved Drugs Containing Sulfur Atoms." In Sulfur Chemistry, 1–34. Cham: Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-030-25598-5_1.

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Péladeau, Christine, and Bernard J. Jasmin. "Identifying FDA-Approved Drugs that Upregulate Utrophin A as a Therapeutic Strategy for Duchenne Muscular Dystrophy." In Methods in Molecular Biology, 495–510. New York, NY: Springer US, 2022. http://dx.doi.org/10.1007/978-1-0716-2772-3_26.

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López-Márquez, Arístides, Ainhoa Martínez-Pizarro, Belén Pérez, Eva Richard, and Lourdes R. Desviat. "Modeling Splicing Variants Amenable to Antisense Therapy by Use of CRISPR-Cas9-Based Gene Editing in HepG2 Cells." In Methods in Molecular Biology, 167–84. New York, NY: Springer US, 2022. http://dx.doi.org/10.1007/978-1-0716-2010-6_10.

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AbstractThe field of splice modulating RNA therapy has gained new momentum with FDA approved antisense-based drugs for several rare diseases. In vitro splicing assays with minigenes or patient-derived cells are commonly employed for initial preclinical testing of antisense oligonucleotides aiming to modulate splicing. However, minigenes do not include the full genomic context of the exons under study and patients’ samples are not always available, especially if the gene is expressed solely in certain tissues (e.g. liver or brain). This is the case for specific inherited metabolic diseases such as phenylketonuria (PKU) caused by mutations in the liver-expressed PAH gene.Herein we describe the generation of mutation-specific hepatic cellular models of PKU using CRISPR/Cas9 system, which is a versatile and easy-to-use gene editing tool. We describe in detail the selection of the appropriate cell line, guidelines for design of RNA guides and donor templates, transfection procedures and growth and selection of single-cell colonies with the desired variant, which should result in the accurate recapitulation of the splicing defect.
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Abou-el-Enein, Mohamed, and Jordan Gauthier. "The Value of CAR-T-cell Immunotherapy in Cancer." In The EBMT/EHA CAR-T Cell Handbook, 231–34. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-94353-0_46.

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AbstractThe development of genetically modified chimeric antigen receptor (CAR) T-cells to target cancer by conferring tumour antigen recognition has tremendously improved the fight against the disease and broadened treatment options for haematological malignancies (Elsallab et al. 2020b). However, in contrast to conventional drugs that patients can easily access, the implementation of CAR-T-cell therapy in routine clinical practice poses significant challenges. Access to CAR-T-cell products is currently limited to specific certified centres meeting the requirements set up by manufacturers and regulatory agencies. There are also issues regarding insurance coverage, reimbursement, affordability, and pricing, which have critical impacts on broadening patient access to these novel therapies (Abou-El-Enein et al. 2016a, b). Current list pricing ranges between $373,000 and $475,000 per one-time infusion for the four CAR-T-cell therapies currently approved by the FDA (tisagenlecleucel, Kymriah®; axicabtagene ciloleucel, Yescarta®; brexucabtagene autoleucel, Tecartus®; lisocabtagene maraleucel, Breyanzi®). In addition to the cost of the CAR-T-cell product, patient preparation (leukapheresis and/or lymphodepletion), product infusion, pre- and post-infusion patient management, and monitoring for side effects (Wagner et al. 2021) significantly add to the final price tag. There are calls for restructuring the current payment and reimbursement models to allow better access to CAR-T-cell therapies (Abou-El-Enein et al. 2014). However, this would only be possible after examining the strength of clinical evidence generated during product development (Abou-El-Enein and Hey 2019; Elsallab et al. 2020a) and, most importantly, by determining the value of CAR-T-cell therapy.
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Conference papers on the topic "FDA-approved drug"

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Raynal, Noël J., Justin T. Lee, Youjun Wang, Judith Garriga, Gabriel Malouf, Sarah Dumont, Elisha J. Dettman, et al. "Abstract 380: Discovery of new epigenetic drugs among FDA-approved drug libraries." In Proceedings: AACR Annual Meeting 2014; April 5-9, 2014; San Diego, CA. American Association for Cancer Research, 2014. http://dx.doi.org/10.1158/1538-7445.am2014-380.

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Ganapathy, Vadivel, Ellappan Babu, Sabarish Ramachandran, and Yangzom D. Bhutia. "Abstract 1015: Repurposing the FDA-approved drug carbidopa to treat human cancers." In Proceedings: AACR 107th Annual Meeting 2016; April 16-20, 2016; New Orleans, LA. American Association for Cancer Research, 2016. http://dx.doi.org/10.1158/1538-7445.am2016-1015.

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Tatman, Philip, Anthony Fringuello, Denise Damek, Samy Youssef, Randy Jensn, Kevin Lillehei, and Michael Graner. "High-Throughput Drug Screening of FDA-Approved Cancer Drugs Reveals Novel Therapies for Patients with Chordomas." In 29th Annual Meeting North American Skull Base Society. Georg Thieme Verlag KG, 2019. http://dx.doi.org/10.1055/s-0039-1679578.

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Gupta, Nancy Sanjay, and Pravir Kumar. "TDP-43 Inhibitors in Amyotrophic Lateral Sclerosis: An Application of Drug Repurposing Approach Using FDA-Approved Drugs." In 2023 International Conference on Computational Intelligence and Sustainable Engineering Solutions (CISES). IEEE, 2023. http://dx.doi.org/10.1109/cises58720.2023.10183592.

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Ding, Andy S., Joshua Casaos, Sakibul Huq, Henry Brem, Nicolas Skuli, and Betty Tyler. "Abstract 2190: Repurposing the FDA-approved antiviral drug ribavirin as targeted therapy for nasopharyngeal carcinoma." In Proceedings: AACR Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA. American Association for Cancer Research, 2019. http://dx.doi.org/10.1158/1538-7445.sabcs18-2190.

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Ding, Andy S., Joshua Casaos, Sakibul Huq, Henry Brem, Nicolas Skuli, and Betty Tyler. "Abstract 2190: Repurposing the FDA-approved antiviral drug ribavirin as targeted therapy for nasopharyngeal carcinoma." In Proceedings: AACR Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA. American Association for Cancer Research, 2019. http://dx.doi.org/10.1158/1538-7445.am2019-2190.

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Huq, Sakibul, Joshua Casaos, Michael Peters, Yuanxuan Xia, Andy Ding, Manuel Morales, Noah Gorelick, et al. "Abstract B06: Repositioning the FDA-approved antiviral drug ribavirin as targeted therapy for nasopharyngeal carcinoma." In Abstracts: AACR-AHNS Head and Neck Cancer Conference: Optimizing Survival and Quality of Life through Basic, Clinical, and Translational Research; April 29-30, 2019; Austin, TX. American Association for Cancer Research, 2020. http://dx.doi.org/10.1158/1557-3265.aacrahns19-b06.

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Mitash, N., H. N. Alsafadi, R. H. Pineda, K. Kohler, M. Ishizuka, J. Sembrat, M. Lehmann, R. Chambers, D. E. Wagner, and M. Koenigshoff. "Inhibition of YAP/TAZ Signaling by the FDA Approved Drug Verteporfin Attenuates Fibrosis in Mouse and Human Tissue." In American Thoracic Society 2022 International Conference, May 13-18, 2022 - San Francisco, CA. American Thoracic Society, 2022. http://dx.doi.org/10.1164/ajrccm-conference.2022.205.1_meetingabstracts.a5226.

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Senbabaoglu, Filiz, Ahmet Cingöz, Ezgi Kaya, Selena Kazancioglu, Nathan Alan Lack, Ceyda Acilan, and Tugba Bagci-Onder. "Abstract B73: Screen among 1200 FDA-approved drug library reveals mitoxantrone as a TRAIL-sensitizing agent for glioblastoma multiforme." In Abstracts: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; November 5-9, 2015; Boston, MA. American Association for Cancer Research, 2015. http://dx.doi.org/10.1158/1535-7163.targ-15-b73.

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Schultz, Christopher W., Teena Dhir, Samantha Z. Brown, Saswati Chand, Wei Jiang, Grace A. McCarthy, Alex O. Haber, et al. "Abstract 3058: Recharacterizing the FDA approved drug pyrvinium pamoate as a clinically relevant HuR inhibitor in pancreatic ductal adenocarcinoma." In Proceedings: AACR Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA. American Association for Cancer Research, 2019. http://dx.doi.org/10.1158/1538-7445.am2019-3058.

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Reports on the topic "FDA-approved drug"

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Matthews, Lisa, Guanming Wu, Robin Haw, Timothy Brunson, Nasim Sanati, Solomon Shorser, Deidre Beavers, Patrick Conley, Lincoln Stein, and Peter D'Eustachio. Illuminating Dark Proteins using Reactome Pathways. Reactome, October 2022. http://dx.doi.org/10.3180/poster/20221027matthews.

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Diseases are often the consequence of proteins or protein complexes that are non-functional or that function improperly. An active area of research has focused on the identification of molecules that can interact with defective proteins and restore their function. While 22% percent of human proteins are estimated to be druggable, less than fifteen percent are targeted by FDA-approved drugs, and the vast majority of untargeted proteins are understudied or so-called "dark" proteins. Elucidation of the function of these dark proteins, particularly those in commonly drug-targeted protein families, may offer therapeutic opportunities for many diseases. Reactome is the most comprehensive, open-access pathway knowledgebase covering 2585 pathways and including 14246 reactions, 11088 proteins, 13984 complexes, and 1093 drugs. Placing dark proteins in the context of Reactome pathways provides a framework of reference for these proteins facilitating the generation of hypotheses for experimental biologists to develop targeted experiments, unravel the potential functions of these proteins, and then design drugs to manipulate them. To this end, we have trained a random forest with 106 protein/gene pairwise features collected from multiple resources to predict functional interactions between dark proteins and proteins annotated in Reactome and then developed three scores to measure the interactions between dark proteins and Reactome pathways based on enrichment analysis and fuzzy logic simulations. Literature evidence via manual checking and systematic NLP-based analysis support predicted interacting pathways for dark proteins. To visualize dark proteins in the context of Reactome pathways, we have also developed a new website, idg.reactome.org, by extending the Reactome web application with new features illustrating these proteins together with tissue-specific protein and gene expression levels and drug interactions.
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Screening of ~5500 FDA-approved drugs and clinical candidates for anti-SARS-CoV-2 activity. EMBL-EBI, March 2022. http://dx.doi.org/10.6019/chembl4651402.

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