Converging Generic Drug Product Development: Bioequivalence Design and Reference Product Selection

Author:

Charoo Naseem Ahmad

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference35 articles.

1. US Food and Drug Administration. Hatch-Waxman Letters. 2018. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters. Accessed 17 Mar 2020.

2. US Food and Drug Administration. Abbreviated new drug application (ANDA). 2020. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda. Accessed 17 Mar 2020.

3. Ohno Y. ICH Guidelines—implementation of the 3Rs (refinement, reduction, and replacement): incorporating best scientific practices into the regulatory process. ILAR J. 2002;43:S95–S9898.

4. Gwaza L, Gordon J, Leufkens H, Stahl M, García-Arieta A. Global harmonization of comparator products for bioequivalence studies. AAPS J. 2017;19(3):603–6.

5. Chen M, Blume HH, Beuerle G, Mehta MU, Potthast H, Brandt A, et al. Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence. Eur J Pharm Sci. 2019;127:24–8.

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