Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines

Author:

Yu Yang,Teerenstra Steven,Neef Cees,Burger David,Maliepaard Marc

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference41 articles.

1. Guidance for Industry (2003) Bioavailability and Bioequivalence. Studies for Orally Adminsitered Drug Products-General Considerations. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER)

2. Guidline on the Investigation of Bioequivalence (2010) London: committee for medicinal products for human use (CHMP), European Medicine Agency

3. Annex7 (2006) Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Geneva: World Health Organization

4. Guidance Document-Comparative Bioavailability Standards: Formulations Used for Systemic Effects Canada: Health Canada (2012)

5. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT et al (2009) Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 43(10):1583–97. doi: 10.1345/aph.1M141

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