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Bioequivalence
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#	Item
521	Microsoft Word - sacrat_rop_ccstrta_crd_2012[removed]eng.doc Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:52:31 Dosage forms Respiratory therapy Clinical research Clinical pharmacology Nebulizer Inhaler Bioequivalence Food and Drug Administration Drug discovery Pharmaceutical sciences Pharmacology Medicine
522	What are clinically relevant dissolution specifications? Add to Reading List Source URL: www.fda.gov Language: English Clinical research Bioequivalence Pharmacokinetics In vivo Food and Drug Administration Dissolution testing IVIVC Pharmaceutical sciences Pharmacology Research
523	Groupe consultatif scientifique sur les normes de bioéquivalence pour les médicaments spécificque au sexe (GCS-MSS) Téléconférence - Compte rendu des délibérations - Le 2 juin 2011 Add to Reading List Source URL: www.hc-sc.gc.ca Language: French - Date: 2013-06-24 11:52:30
524	Part 15 Public Hearing: Request for Public Input for FY 2014 Generic Drug Research Robert Lionberger, Ph.D. Deputy Director for Science (acting) Add to Reading List Source URL: www.fda.gov Language: English Pharmacokinetics Pharmaceutical industry Clinical research Bioequivalence Pharmaceuticals policy Food and Drug Administration Generic drug Drug development Bioavailability Pharmaceutical sciences Pharmacology Medicine
525	Generic Drug User Fee Amendments of 2012 Regulatory Science Initiatives: 4. QbD and 6. Anti-epileptic drugs 7. BCS James E. Polli Add to Reading List Source URL: www.fda.gov Language: English Mood stabilizers Clinical research Pharmacy Quality by Design IVIVC QBD Lamotrigine Bioequivalence Pharmaceutics Pharmaceutical sciences Pharmacology Anticonvulsants
526	the sciences of similarity: the role of social science research in generic drug regulation Jeremy A. Greene, MD, PhD Departments of Medicine and the History of Medicine Add to Reading List Source URL: www.fda.gov Language: English Pharmacokinetics Clinical research Bioequivalence Pharmacy Generic drug Bioavailability Biopharmaceutics Classification System Adverse effect Pharmacovigilance Pharmaceutical sciences Pharmacology Health
527	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical pharmacology Food and Drug Administration Generic drug Bioequivalence Center for Drug Evaluation and Research Abbreviated New Drug Application Quality by Design Drug discovery Pharmaceutical sciences Pharmacology Pharmaceutical industry
528	GDUFA Regulatory Science Initiatives, Silver Spring, June[removed]Inhaled Bioequivalence: Supporting a weight of evidence based approach? Pharmaceutical Surface Science Research Group, Add to Reading List Source URL: www.fda.gov Language: English Dosage forms GlaxoSmithKline Asthma Pharmacokinetics Respiratory therapy Fluticasone/salmeterol Dry powder inhaler Inhaler Bioequivalence Pharmacology Medicine Pulmonology
529	GDUFA Regulatory Science Initiatives: 2013 Retrospective and 2014 Prospective David R. Gaugh, R. Ph. Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Research Pharmaceuticals policy Food and Drug Administration Therapeutics Generic drug Abbreviated New Drug Application Bioequivalence New Drug Application Pharmaceutical industry Pharmaceutical sciences Clinical research
530	DRUGS DIRECTORATE SUBMISSION CERTIFICATION for NDSs, S/NDSs, NCs Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-12-02 14:47:36 Drug discovery Pharmaceutical sciences Pharmaceutics Design of experiments Food and Drug Administration Bioequivalence Pre-clinical development Clinical trial Clinical research Pharmaceutical industry Research

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