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Статті в журналах з теми "FOOD AND DRUGS ADMINISTRATION"
Hutcheon, Duncan E. "Drugs Approved by Food & Drug Administration." Journal of Clinical Pharmacology 29, no. 5 (May 1989): 478–79. http://dx.doi.org/10.1002/j.1552-4604.1989.tb03366.x.
Повний текст джерелаFurlan, Anthony J., and Marc Fisher. "Devices, Drugs, and the Food and Drug Administration." Stroke 36, no. 2 (February 2005): 398–99. http://dx.doi.org/10.1161/01.str.0000153057.07181.94.
Повний текст джерелаTsimberidou, Apostolia-Maria, Fadi Braiteh, David J. Stewart, and Razelle Kurzrock. "Ultimate Fate of Oncology Drugs Approved by the US Food and Drug Administration Without a Randomized Trial." Journal of Clinical Oncology 27, no. 36 (December 20, 2009): 6243–50. http://dx.doi.org/10.1200/jco.2009.23.6018.
Повний текст джерелаHaffner, Marlene E., and John V. Kelsey. "Evaluation of Orphan Products by the U.S. Food and Drug Administration." International Journal of Technology Assessment in Health Care 8, no. 4 (1992): 647–57. http://dx.doi.org/10.1017/s0266462300002348.
Повний текст джерелаRangaraj, Nagarjun, Sunitha Sampathi, Vijayabhaskarreddy Junnuthula, Praveen Kolimi, Preethi Mandati, Sagar Narala, Dinesh Nyavanandi, and Sathish Dyawanapelly. "Fast-Fed Variability: Insights into Drug Delivery, Molecular Manifestations, and Regulatory Aspects." Pharmaceutics 14, no. 9 (August 27, 2022): 1807. http://dx.doi.org/10.3390/pharmaceutics14091807.
Повний текст джерелаKharitonovа, L. A., A. M. Zaprudnov, and K. I. Grigoriev. "Mandatory assessment of trophological status and nutrition in children in drugs prescribing." Experimental and Clinical Gastroenterology, no. 1 (May 2, 2020): 4–14. http://dx.doi.org/10.31146/1682-8658-ecg-173-1-4-14.
Повний текст джерелаSharma, Ajitha, and Rathnakar Up. "REVISED FOOD AND DRUG ADMINISTRATION RISK CATEGORIES OF DRUGS DURING PREGNANCY." Asian Journal of Pharmaceutical and Clinical Research 10, no. 7 (July 1, 2017): 77. http://dx.doi.org/10.22159/ajpcr.2017.v10i7.16539.
Повний текст джерелаButler, O. D., Woodrow M. Knight, and Jack C. Taylor. "The Regulation of Production Drugs by the Food and Drug Administration." Professional Animal Scientist 2, no. 1 (June 1986): 14–17. http://dx.doi.org/10.15232/s1080-7446(15)32415-3.
Повний текст джерелаBlankfield, Robert P., and Imran H. Iftikhar. "Food and Drug Administration Regulation of Drugs That Raise Blood Pressure." Journal of Cardiovascular Pharmacology and Therapeutics 20, no. 1 (May 6, 2014): 5–8. http://dx.doi.org/10.1177/1074248414531852.
Повний текст джерелаAshley, Donald D. "Clarifying Misconceptions About US Food and Drug Administration Unapproved Drugs Program." Anesthesia & Analgesia 127, no. 6 (December 2018): 1292–94. http://dx.doi.org/10.1213/ane.0000000000003852.
Повний текст джерелаДисертації з теми "FOOD AND DRUGS ADMINISTRATION"
Li, Hoi-kwong. "Filing of complaints by the US Food and Drug Administration /." View the Table of Contents & Abstract, 2005. http://sunzi.lib.hku.hk/hkuto/record/B35082471.
Повний текст джерелаLi, Hoi-kwong, and 李海光. "Filing of complaints by the US Food and Drug Administration." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2005. http://hub.hku.hk/bib/B45010766.
Повний текст джерелаLamb, James Alexander. "Under-reporting of Adverse Drug Reactions to the Food & Drug Administration." ScholarWorks, 2018. https://scholarworks.waldenu.edu/dissertations/6055.
Повний текст джерелаWang, Bo. "Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels." Thesis, Harvard University, 2016. http://nrs.harvard.edu/urn-3:HUL.InstRepos:27007749.
Повний текст джерелаRichert, Lucas. "Pills, politics, and pitfalls : The food and drug administration during the Reagan years." Thesis, University of London, 2010. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.536790.
Повний текст джерелаMayhew, Brian Michael. "An evaluation of the food and drug administration’s expedited pathways." reponame:Repositório Institucional do FGV, 2016. http://hdl.handle.net/10438/17995.
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Biopharmaceutical development is characterized by challenging regulations, intense competition and significant costs that result in the need for biopharmaceutical companies to consistently produce innovation biopharmaceutical products. The United States Congress has sought to provide a balanced environment that combines significant regulatory oversight by the US Food and Drug Administration (FDA) with market-based incentives (patent protection, exclusivity) and expedited pathways (accelerated approval, breakthrough designation, fast track designation, and priority review) that seek to quickly identify and move innovative new medicines through development that will address unmet medical need and treat serious or life-threatening diseases or conditions. While FDA’s expedited programs are believed to accelerate the development of innovative drug products, the programs have not been formally measured against their intended purpose: more efficient development and regulatory reviews. This thesis research project attempts to effectively measure FDA’s expedited programs by cataloguing FDA approvals from 1987-2015, measuring development and regulatory review time, and drawing conclusions and making recommendations based on the statistical analyses generated from the project.
Garmendia, Craig A. "Patterns of Regularity Noncompliance Identified by the U.S. Food and Drug Administration and Their Effects on Meta-analyses." FIU Digital Commons, 2018. https://digitalcommons.fiu.edu/etd/3920.
Повний текст джерелаBalmaceda, Zaira, and Kathy Lin. "Comparison of Findings from Published Weight Loss Trials for Orlistat to the Findings Used by the Food and Drug Administration (FDA)." The University of Arizona, 2010. http://hdl.handle.net/10150/623796.
Повний текст джерелаOBJECTIVES: The objective was to compare differences in weight loss data presented in published orlistat studies on orlistat to their corresponding studies submitted to the FDA. METHODS: This meta-‐analysis compared one-‐year weight loss data reported in six published orlistat 120 mg studies to data reviewed by the FDA in the New Drug Application (NDA). The primary dependent variables were the percentage of subjects achieving 5% and 10% weight loss. Prior to analysis, weight loss data was stratified into placebo and orlistat groups. Potential for bias was assessed with a funnel plot and by calculating Kendall’s tau. The a priori alpha level was 0.05. RESULTS: Corresponding FDA reviews were located for 6 published orlistat trials. The pooled odds ratio of published vs. FDA 5%weight loss data for the placebo arm was 2.18 (95% CI: 1.83 to 2.60; p < 0.001) and 1.95 (95% CI: 1.70 to 2.24; p < 0.001) for the orlistat arm. The pooled odds ratio of published vs. FDA for 10% weight loss data for the placebo arm was 2.25 (95% CI: 1.74 to 2.91; p < 0.001) and 2.20 (95% CI: 1.88 to 2.57; p < 0.001) for the orlistat arm. The p-‐values for Kendall’s tau for the 5% and 10% weight loss data were 0.054 and 0.34, respectively. CONCLUSIONS: Published orlistat trials presented 5% and 10% weight loss data that were twice of that reported in the FDA-‐reviewed trials, and there was potential for bias in the 5% weight loss data.
Noh, In Joon. "Essays on Drivers of Quality and Compliance Performance in the Pharmaceutical Industry: Policy, Manufacturing Strategy, and Organizational Learning Perspectives." The Ohio State University, 2020. http://rave.ohiolink.edu/etdc/view?acc_num=osu1595014194719331.
Повний текст джерелаBarrett, Jane A. "Applying strategles of architectural androgeny to a renovation of and addition to an existing building currently occupied by the food and drug administration." Thesis, Georgia Institute of Technology, 1994. http://hdl.handle.net/1853/23446.
Повний текст джерелаКниги з теми "FOOD AND DRUGS ADMINISTRATION"
O'Reilly, James T. Food and drug administration. 2nd ed. [Eagan, MN]: Thomson/West, 2005.
Знайти повний текст джерелаO'Reilly, James T. Food and drug administration. 2nd ed. [St. Paul, Minn.]: Thomson/West, 2005.
Знайти повний текст джерелаO'Reilly, James T. Food and drug administration. 2nd ed. Colorado Springs, Colo: Shepard's/McGraw-Hill, 1993.
Знайти повний текст джерелаThe Food and Drug Administration. New York, N.Y: Chelsea House, 1988.
Знайти повний текст джерелаA, Rettig Richard, Earley Laurence E, Merrill Richard A, and Institute of Medicine (U.S.). Division of Health Sciences Policy., eds. Food and Drug Administration advisory committees. Washington, D.C: National Academy Press, 1992.
Знайти повний текст джерелаCenter for Drug Evaluation and Research (U.S.), ed. Drugs@FDA. Washington D.C: U.S. Food and Drug Administration, Center for Drug and Evaluation Research, 2004.
Знайти повний текст джерелаBuchta, Teresa M. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.
Знайти повний текст джерелаUnited States. Food and Drug Administration. Cincinnati District Office and National Institute for Occupational Safety and Health, eds. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.
Знайти повний текст джерелаBuchta, Teresa M. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.
Знайти повний текст джерелаPhilipson, Tomas J. Is the Food and Drug Administration safe and effective? Cambridge, Mass: National Bureau of Economic Research, 2007.
Знайти повний текст джерелаЧастини книг з теми "FOOD AND DRUGS ADMINISTRATION"
Gibbs, Jeffrey N., Iver P. Cooper, and Bruce F. Mackler. "Food and Drug Administration." In Biotechnology & the Environment: International Regulation, 115–24. London: Macmillan Education UK, 1987. http://dx.doi.org/10.1007/978-1-349-09160-7_7.
Повний текст джерелаGressner, A. M., and O. A. Gressner. "Food and Drug Administration." In Lexikon der Medizinischen Laboratoriumsdiagnostik, 1. Berlin, Heidelberg: Springer Berlin Heidelberg, 2017. http://dx.doi.org/10.1007/978-3-662-49054-9_1160-1.
Повний текст джерелаGressner, A. M., and O. A. Gressner. "Food and Drug Administration." In Springer Reference Medizin, 899. Berlin, Heidelberg: Springer Berlin Heidelberg, 2019. http://dx.doi.org/10.1007/978-3-662-48986-4_1160.
Повний текст джерелаNahler, Gerhard. "Food and Drug Administration (FDA)." In Dictionary of Pharmaceutical Medicine, 76. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_574.
Повний текст джерелаGooch, Jan W. "Food and Drug Administration (FDA)." In Encyclopedic Dictionary of Polymers, 321. New York, NY: Springer New York, 2011. http://dx.doi.org/10.1007/978-1-4419-6247-8_5212.
Повний текст джерелаDesanto, Barbara. "US Food and Drug Administration." In The Palgrave Encyclopedia of Interest Groups, Lobbying and Public Affairs, 1450–55. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-44556-0_227.
Повний текст джерелаPati, Sandipan, and Steve S. Chung. "Approach of the Food and Drug Administration in Development of Antiepileptic Drugs." In Atlas of Epilepsies, 1609–13. London: Springer London, 2010. http://dx.doi.org/10.1007/978-1-84882-128-6_242.
Повний текст джерелаWeissinger, Judi. "Assessment of Reproductive Toxicology of Drugs at the Food and Drug Administration." In Risk Assessment of Prenatally-Induced Adverse Health Effects, 103–11. Berlin, Heidelberg: Springer Berlin Heidelberg, 1992. http://dx.doi.org/10.1007/978-3-642-77753-0_7.
Повний текст джерелаBlock, Walter E. "The Food and Drug Administration Challenger." In Defending the Undefendable III, 137–39. Singapore: Springer Singapore, 2021. http://dx.doi.org/10.1007/978-981-16-3957-9_38.
Повний текст джерелаLi, Haodi, Qingcai Chen, Buzhou Tang, Dong Huang, Xiaolong Wang, and Zengjian Liu. "An Initial Ingredient Analysis of Drugs Approved by China Food and Drug Administration." In Communications in Computer and Information Science, 104–9. Singapore: Springer Singapore, 2016. http://dx.doi.org/10.1007/978-981-10-3168-7_10.
Повний текст джерелаТези доповідей конференцій з теми "FOOD AND DRUGS ADMINISTRATION"
Tapia, J. Carlos, Consolación Molto, Aida Bujosa, Arnoud J. Templeton, Agustí Barnadas, Eithan Amir, and Ariadna Tibau. "Abstract PD10-06: Clinical benefit of breast cancer drugs approved by the United States Food and Drug Administration." In Abstracts: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, Texas. American Association for Cancer Research, 2020. http://dx.doi.org/10.1158/1538-7445.sabcs19-pd10-06.
Повний текст джерелаRose, Charles L. "The food and drug administration (FDA) submission process." In ICALEO® ‘86: Proceedings of the Medicine and Surgery Symposium. Laser Institute of America, 1986. http://dx.doi.org/10.2351/1.5057788.
Повний текст джерелаAlbuquerque, Pedro José Honório de, Laura Guerra Lopes, Jordy Silva de Carvalho, Luzilene Pereira de Lima, and Marina Galdino da Rocha Pitta. "Emerging therapies for amyotrophic lateral sclerosis applied to drug discovery." In XIII Congresso Paulista de Neurologia. Zeppelini Editorial e Comunicação, 2021. http://dx.doi.org/10.5327/1516-3180.021.
Повний текст джерелаPera, V., P. Rijnbeek, J. Van Der Lei, J. Kors, R. Parry, E. Van Mulligen, M. De Wilde, G. Brusselle, G. Brusselle, and K. Verhamme. "Characteristics of medication errors among respiratory drugs within the Food and Drug Administration’s Adverse Event Reporting System." In ERS International Congress 2022 abstracts. European Respiratory Society, 2022. http://dx.doi.org/10.1183/13993003.congress-2022.283.
Повний текст джерелаEtan, Tal, Eitan Amir, Adriana Tibau, Rinat Yerushalmi, Assaf Moore, Daniel Shepshelovich, and Hadar Goldvaser. "Abstract PS14-13: National comprehensive cancer network (NCCN) recommendations for drugs without US food and drug administration (FDA) approval in metastatic breast cancer: A cross-sectional study." In Abstracts: 2020 San Antonio Breast Cancer Virtual Symposium; December 8-11, 2020; San Antonio, Texas. American Association for Cancer Research, 2021. http://dx.doi.org/10.1158/1538-7445.sabcs20-ps14-13.
Повний текст джерелаBeekman, Jessica, Samantha Popol, Shaun MacMahon, and Steven Peyton. "Analysis of MCPD and Glycidyl Esters: Recent Occurrence Data in U.S. Infant Formulas and Effects of Cooking on Contaminant Concentrations in Frozen Fried Foods." In 2022 AOCS Annual Meeting & Expo. American Oil Chemists' Society (AOCS), 2022. http://dx.doi.org/10.21748/jsat7828.
Повний текст джерелаHudson, B. J. "Exporting medical devices to the USA (how to do business with the Food and Drug Administration)." In IEE Seminar Exporting Medical Devices to the USA: A Practical Guide to the FDA Regulations. IEE, 1998. http://dx.doi.org/10.1049/ic:19980988.
Повний текст джерелаLueddemann, Tobias, Diqing Chang, Sadik Sahin, and Tim C. Lueth. "Medical device approval process in China since the introduction of the China Food and Drug Administration." In 2016 IEEE Symposium on Product Compliance Engineering (ISPCE). IEEE, 2016. http://dx.doi.org/10.1109/ispce.2016.7492842.
Повний текст джерелаSanders, Michael J. "Aseptic Processing and Handling of Citrus Juice." In ASME 1990 Citrus Engineering Conference. American Society of Mechanical Engineers, 1990. http://dx.doi.org/10.1115/cec1990-3606.
Повний текст джерелаEakin, Cortney, Cheng-I. Liao, Joshua Cohen, Ritu Salani, Daniel Kapp, and John K. Chan. "O013/#813 Trends of metastatic leiomyosarcoma following the us food and drug administration (FDA) warning on laparoscopic power morcellators." In IGCS 2022 Annual Meeting Abstracts. BMJ Publishing Group Ltd, 2022. http://dx.doi.org/10.1136/ijgc-2022-igcs.15.
Повний текст джерелаЗвіти організацій з теми "FOOD AND DRUGS ADMINISTRATION"
Philipson, Tomas, and Eric Sun. Is the Food and Drug Administration Safe and Effective? Cambridge, MA: National Bureau of Economic Research, October 2007. http://dx.doi.org/10.3386/w13561.
Повний текст джерелаBlanchard, A. Derived Intervention Levels for Tritium Based on Food and Drug Administration Methodology. Office of Scientific and Technical Information (OSTI), December 1998. http://dx.doi.org/10.2172/4840.
Повний текст джерелаDEPARTMENT OF DEFENSE WASHINGTON DC. Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs. Fort Belvoir, VA: Defense Technical Information Center, February 2008. http://dx.doi.org/10.21236/ada594572.
Повний текст джерелаBlanchard, A. Derived Intervention Levels for Tritium Based on Food and Drug Administration Methodology Using ICRP 56 Dose Coefficients. Office of Scientific and Technical Information (OSTI), June 1999. http://dx.doi.org/10.2172/7962.
Повний текст джерелаMiller, Patrice, and Alexis Williams. COVID-19’s Impact on Clinical Research. RTI Press, December 2022. http://dx.doi.org/10.3768/rtipress.2022.rb.0032.2212.
Повний текст джерелаHuang, Jinsheng, Teng Fan, Yuming Rong, Xujia Li, Qi Jiang, Jun Kan, Huijuan Qiu, Qi Quan, Bei Guo, and Guifang Guo. Efficacy of Aidi injection combined with chemotherapy, radiotherapyor chemoradiotherapy for unresectable esophageal cancer treatment: A meta-analysis and systematic review of 29 randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, September 2022. http://dx.doi.org/10.37766/inplasy2022.9.0020.
Повний текст джерелаGupta, Aditya, Tong Wang, Shruthi Ravi, Mesbah Talukder, Jessie Carviel, and Mary Bamimore. Relative efficacy of microneedling in the treatment of pattern hair loss: a protocol for a systematic review with network meta-analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, September 2022. http://dx.doi.org/10.37766/inplasy2022.9.0042.
Повний текст джерелаLaw, Marc, and Gary Libecap. The Determinants of Progressive Era Reform: The Pure Food and Drugs Act of 1906. Cambridge, MA: National Bureau of Economic Research, December 2004. http://dx.doi.org/10.3386/w10984.
Повний текст джерелаDeng, Jianhao, jiaxing Zhang, QingXia Zhang, and Guowei Zhong. Serotonin syndrome with dextromethorphan alone and in combination with other serotonergic drugs. a systematic review. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, May 2022. http://dx.doi.org/10.37766/inplasy2022.5.0079.
Повний текст джерелаBergwerff, A. Residues of veterinary drugs in food : keynote, oral and poster contributions : proceedings of the EuroResidue VIII conference Egmond aan Zee, The Netherlands 23-25 May, 2016. Wageningen: Wageningen UR, 2016. http://dx.doi.org/10.18174/370325.
Повний текст джерела