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Harmonisation
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961	Guidance for Industry M4Q: The CTD-Quality August 2001 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Clinical Data Management Medical informatics Common Technical Document Food and Drug Administration International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Validation Package insert Clinical research Research Pharmaceutical sciences
962	Guidance for Industry M4: The CTD - General Questions and Answers Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Pharmaceutical industry Health Drug safety Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Marketing authorization Clinical research Research Clinical Data Management
963	Microsoft Word - 7042fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Electronic Common Technical Document Drug safety Common Technical Document HTML element International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use HTML Food and Drug Administration Research Clinical research Clinical Data Management
964	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
965	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
966	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
967	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
968	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
969	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
970	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