The Impact of the EMA Change in Definition of “Dose” on the BCS Dose–Solubility Ratio: A Review of the Biowaiver Monographs

Author:

Sediq Ahmad,Kubbinga Marlies,Langguth Peter,Dressman Jennifer

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference32 articles.

1. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability;Amidon;Pharm Res,1995

2. European Medicines Agency, Committee for Medicinal Products for Human Use. 2001. Note for guidance on the investigation of bioavailability and bioequivalence. Accessed July 1, 2012, at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003008.pdf.

3. US Department of Health and Human Services, Food and Drug Administration. 2000. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate‐release solid oral dosage forms based on a Biopharmaceutics Classification System. Accessed November 9, 2012, at: http://www.fda.gov.

4. >European Medicines Agency, Committee for Medicinal Products for Human Use. 2010. Guideline on the investigation of bioequivalence. Accessed July 1, 2012, at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.

5. World Health Organization. 2006. Proposal to waive in vivo bioequivalence requirements for WHO model list of essential medicines immediate‐release, solid oral dosage forms. Annex 8 of WHO expert committee on specifications for pharmaceutical preparations. Accessed July 1, 2012, at: http://apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex8_eng.pdf.

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