A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: A cross-sectional survey with 500 bioequivalence studies

Author:

Cristofoletti Rodrigo,Chiann Chang,Dressman Jennifer B.,Storpirtis Silvia

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference62 articles.

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

5. US Food and Drug Administration (FDA). 1995. Guidance for industry: Scale-up and post approval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. Accessed July 10, 2012, at: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070636.pdf.

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