Good Clinical Practice

Results: 1284



#Item
991Pharmacology / Health / Clinical pharmacology / Food and Drug Administration / United States Public Health Service / Abbreviated New Drug Application / Generic drug / Good manufacturing practice / Drug Price Competition and Patent Term Restoration Act / Pharmaceuticals policy / Pharmaceutical sciences / Pharmaceutical industry

FDA206.121_SLIM_generic slimjim

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Source URL: www.fda.gov

Language: English
992Pharmacology / Medical technology / Pharmaceutical industry / Good Laboratory Practice / Organisation for Economic Co-operation and Development / Drug discovery / Food and Drug Administration / Medical device / Clinical trial / Medicine / Health / Pharmaceutical sciences

CENTER FOR DRUG EVALUATION AND RESEARCH SPECIAL INTEREST TOPIC TITLE: GLP Regulations (Management Briefings, 8/79) and GLP Regulations (Questions/Answers, 6/81)

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Language: English
993Health / Clinical research / Pharmaceuticals policy / Pharmaceutical industry / Therapeutics / Center for Veterinary Medicine / Good manufacturing practice / Regulatory requirement / Pharmaceutical sciences / Food and Drug Administration / Pharmacology

Staff Manual Guide[removed]

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Source URL: www.fda.gov

Language: English
994Health / Pharmacology / Validity / Clinical research / Good Laboratory Practice / Organisation for Economic Co-operation and Development / Food and Drug Administration / Title 21 of the Code of Federal Regulations / Verification and validation / Pharmaceutical industry / Pharmaceutical sciences / Science

Guidance for Industry Good Laboratory Practices Questions and Answers U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
995pharmacology / Form FDA 483 / Clinical investigator / Inspection / EIR / Medicinal chemistry / Food and Drug Administration / Pharmaceutical sciences / clinical research

Clinical Investigator Inspections: What to Expect Constance Cullity, MD, MPH Branch Chief Good Clinical Practice Enforcement Branch Division of Good Clinical Practice Compliance

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Source URL: www.fda.gov

Language: English
996Pharmaceutical industry / Medicine / Pharmacology / Food and Drug Administration / Design of experiments / Clinical trial / Title 21 of the Code of Federal Regulations / Quality management system / Good Clinical Practice / Clinical research / Research / Pharmaceutical sciences

BUILDING QUALITY INTO CLINICAL TRIALS – AN FDA PERSPECTIVE Jean Toth-Allen, Ph.D. Biophysicist Office of Good Clinical Practice

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Source URL: www.fda.gov

Language: English
997Pharmacology / Pharmaceutical industry / Pharmaceuticals policy / Food and Drug Administration / Design of experiments / Good manufacturing practice / Clinical trial / Medical device / Medicine / Health / Pharmaceutical sciences

Statement of Intent between FDA and MoHandFW

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Source URL: www.fda.gov

Language: English
998Pharmacology / Pharmaceutical industry / Design of experiments / Clinical trial / Institutional review board / Clinical investigator / Good Clinical Practice / Food and Drug Administration / ClinicalTrials.gov / Clinical research / Research / Science

Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
999Pharmaceutical industry / Food safety / Clinical research / Validity / Food and Drug Administration / Drug reference standard / Validation / Good manufacturing practice / Methamphetamine / Pharmacology / Pharmaceutical sciences / Medicine

Microsoft Word - 7385fnl.doc

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Source URL: www.fda.gov

Language: English
1000Pharmaceutical industry / Clinical research / Pharmaceuticals policy / Food and Drug Administration / Quality / Validation / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Center for Biologics Evaluation and Research / Good manufacturing practice / Medicine / Health / Pharmaceutical sciences

Microsoft Word - 9621fnl.doc

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Source URL: www.fda.gov

Language: English
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