Analytical, biopharmaceutical and regulatory evaluation of topical testosterone preparations

Author:

Baert B.,Annavarapu S.,Burvenich C.,De Spiegeleer B.

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference25 articles.

1. FDA, SUPAC-SS Guidance for Industry Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In vitro Release Testing and In vivo Bioequivalence Documentation. in: U.S.D.o.H.a.H. Services (Ed.), Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 1997.

2. Assessment of value and applications of in vitro testing of topical dermatological drug products;Flynn;Pharm. Res.,1999

3. Evaluation of the test system used for in vitro release of drugs for topical dermatological drug products;Shah;Pharm. Dev. Technol.,1999

4. ICH, Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Products: Chemical Substances, 1999.

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