Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds

Author:

Tubic-Grozdanis Marija,Bolger Michael B.,Langguth Peter

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference68 articles.

1. G. L. Amidon, H. Lennernäs, V. P. Shah, and J. R. Crison. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12(3):413–420 (1995),1995/03/01.

2. F. D. A. Guidance. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. US Food and Drug Administration Center for Drug Evaluation and Research (2000).

3. CPMC (EU). CPMP Note for Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98). (2001).

4. W. Preparations, G. W. H. Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations: World Health Organization (2006).

5. E. Rinaki, A. Dokoumetzidis, G. Valsami, and P. Macheras. Identification of biowaivers among class II drugs: theoretical justification and practical examples. Pharm. Res. 21(9):1567–1572 (2004).

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