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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
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271	Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 6 Uniformity of Dosage Units General Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Clinical research Food and Drug Administration Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research United States Pharmacopeia Health Canada Medicine Health Pharmacopoeias
272	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE DRAFT ICH CONSENSUS PRINCIPLE PRINCIPLES FOR CLINICAL EVALUATION OF Add to Reading List Source URL: www.fda.gov Language: English Science Pharmacology Design of experiments Evaluation methods Bioethics Clinical trial Reserpine Placebo-controlled study Hypertension Medicine Clinical research Health
273	Microsoft Word - 8670fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical research Pharmacopoeias Pharmaceuticals policy Center for Biologics Evaluation and Research International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Biologic Center for Drug Evaluation and Research Medicine Food and Drug Administration Health
274	Microsoft Word - 10558fnl[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Pharmaceuticals policy Pharmacopoeias Drug safety International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Bulk density Medicine Health Pharmaceutical sciences
275	Microsoft Word - 8923fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Drug safety Pharmacopoeias Medical device International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Health Canada Medicine Health Food and Drug Administration
276	Guidance for Industry M4: The CTD - Safety Questions and Answers Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmacology Clinical Data Management Common Technical Document Center for Biologics Evaluation and Research International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Drug Evaluation and Research Good Laboratory Practice Biologic Clinical research Research Medicine
277	E2BM Data Elements for Transmission Of Individual Case Safety Reports Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Science Pharmaceutical industry Drug safety Design of experiments Adverse event Clinical trial International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Specification Clinical research Research Pharmacology
278	Guidance for Industry M4: The CTD — Quality Questions and Answers/ Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Clinical Data Management Pharmaceuticals policy Validation Drug Master File International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Common Technical Document HTML element Clinical research Research Pharmaceutical sciences
279	Guidance for Industry M2: eCTD Specification Questions & Answers and Change Requests Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Food and Drug Administration Drug safety Medical informatics Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Medicine Research Clinical research
280	Microsoft Word - 8079fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Pharmaceuticals policy Drug safety Center for Biologics Evaluation and Research International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmacopoeia Biologic Center for Drug Evaluation and Research Medicine Food and Drug Administration Health