A Comparison of FDA, EMA, ANVISA, and Others on Bioanalysis in Support of Bioequivalence/ Bioavailability Studies

Author:

Nash Bradley

Publisher

John Wiley & Sons Inc.

Reference11 articles.

1. Brazilian Sanitary Surveillance Agency Manual for Good Bioavailability and Bioequivalence Practices-Volume 1 2002

2. Center for Drug Evaluation, State Food and Drug Administration 2009 www.cde.org.tw/English/Regulations/SubLink/Document%2004.pdf

3. Center for Drug Evaluation and Research “Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations.” United States Food and Drug Administration 2003 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf

4. Central Dugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. Guidelines for Bioavailability & Bioequivalence Studies 2005

5. European Medicines Agency 2010 www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf

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