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Center for Drug Evaluation and Research
Results: 4314

#	Item
151	Guidance for Industry Population Pharmacokinetics U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Add to Reading List Source URL: www.fda.gov Language: English Pharmacy Pharmacokinetics Evaluation methods Pharmaceutical industry Pharmacodynamics Food and Drug Administration Sampling Statistics Clinical trial Pharmaceutical sciences Pharmacology Science
152	Institutional Effectiveness Report – [removed]Assessment Summary Administrative Unit: Center for Business and Economic Research (CBER) Contact Person: Email: Phone: Add to Reading List Source URL: valdosta.edu Language: English - Date: 2014-04-09 07:27:41 Medicine Biology Health Center for Business and Economic Research Food and Drug Administration Center for Biologics Evaluation and Research
153	Microsoft Word - Final Summary Minutes EMDAC[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Benzazepines Lorcaserin Pharmaceutical sciences Anti-obesity medication Center for Drug Evaluation and Research Mammary tumor Health Medicine Organochlorides
154	E-ALERT \| Food & Drug January 22, 2014 FDA ISSUES DRAFT GUIDANCE ON REQUIREMENTS FOR POSTMARKETING SUBMISSIONS OF SOCIAL MEDIA On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Add to Reading List Source URL: www.cov.com Language: English - Date: 2014-01-22 09:57:05 Clinical research Pharmacology Clinical pharmacology Therapeutics United States Public Health Service Covington & Burling Center for Biologics Evaluation and Research User-generated content Food and Drug Administration Pharmaceutical sciences Medicine
155	CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022571Orig1s000 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-02-23 11:56:30 Piperidines Muscarinic antagonists Organofluorides Amines Glycopyrrolate Haloperidol Methadone Chemistry Organic chemistry Alcohols
156	DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Center for Drug Evaluation and Research Division of Pharmaceutical Analysis St. Louis, MO[removed]Tel[removed] Add to Reading List Source URL: www.stop-tabac.ch Language: English - Date: 2010-09-07 10:19:42 Pyridines Chemistry Addiction Electronic cigarette Nicotine Cotinine Tobacco-specific nitrosamines Cigarette Quest Tobacco Smoking Nicotinic agonists
157	Microsoft PowerPoint - Development of Pharmaceutical QSAR Models for Regulatory Purposes.ppt Add to Reading List Source URL: www.opentox.org Language: English - Date: 2011-10-26 07:30:21 Medicinal chemistry Clinical research Pharmaceutical industry Clinical pharmacology Quantitative structure–activity relationship Food and Drug Administration Validation Center for Drug Evaluation and Research Drug discovery Pharmaceutical sciences Pharmacology Science
158	Watch pages FDA’s New Guidance on Biomarkers and Patient Reported Outcome Qualification Last fall the FDA issued draft guidance related to the Add to Reading List Source URL: www.wwctrials.com Language: English - Date: 2011-10-12 16:13:24 Pharmacology Food and Drug Administration Pharmaceutical industry Drug discovery DDT Biomarker Center for Drug Evaluation and Research Medical device Drug development Medicine Health Clinical research
159	Regulatory Considerations for Plant-Based Biologics Manufactured in Contained Facilities Santosh Nanda, DVM, Ph.D. Microbiologist/ Primary Reviewer Add to Reading List Source URL: arssymposium.absa.org Language: English - Date: 2014-06-06 00:31:21 Medicine Microbiology Biologic Center for Biologics Evaluation and Research Food and Drug Administration Virus Adventitiousness Vaccine Biology Biotechnology Pharmacology
160	Th~sreport contains the colleciive views of on international group o i experts and does noi necessarily represent the decisions or the stated policy oi the World Health Organizaiion WHO EXPERT COMMITTEE ON BIOLOGICAL STA Add to Reading List Source URL: apps.who.int Language: English - Date: 2013-06-02 18:26:46 Biology National Influenza Centres Council of Europe Biologic International unit Center for Biologics Evaluation and Research European Pharmacopoeia Influenza vaccine Food and Drug Administration Pharmacology Biotechnology Medicine

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