Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications

Author:

Suarez-Sharp SandraORCID,Li Min,Duan John,Shah Heta,Seo Paul

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference22 articles.

1. Cardot JM, Beyssac E. In vitro/in vivo correlations: scientific implications and standardisation. Eur J Drug Metab Pharmacokinet. 1993;18(1):113–20.

2. Emami J. In vitro–in vivo correlation: from theory to applications. J Pharm Pharm Sci Publ Can Soc Pharm Sci Soc Can Sci Pharm. 2006;9(2):169–89.

3. Skelley JP, Amidon GL, Barr WH, Benet LZ, Carter JE, Robinson JR, et al. Report of the workshop on in vitro and in vivo testing and correlation for oral controlled/modified-release dosage forms. J Pharm Sci. 1990;79(9):849–54.

4. Van Buskirk GA, Shah V, Yacobi A, Bolger MB, Chittenden J, Davit BM, et al. PQRI workshop report: application of IVIVC in formulation development. Dissolut Technol. 2014;21(2):51–8.

5. Suarez SS. Speaker and moderator at the PQRI Workshop Co-sponsored with FDA, AAPS, USP, and FIP. Title of presentation: FDA’s experience on IVIVC-new drug products. Rockville, MD. 2012. http://pqri.org/wp-content/uploads/2015/08/pdf/Suarez.pdf .

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