In Vitro-In Vivo Correlation: Application to biotech product development

Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development

Volumn , Issue , 2016, Pages 341-356

  Cardot, Jean Michel ^a  

^a UNIVERSITÉ CLERMONT AUVERGNE   (France)

Author keywords

[No Author keywords available]

Indexed keywords

IN-VITRO;

EID: 84947286852     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (11)

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2. Guidance for Industry Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In vivo Correlations. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), September 1997.
3. Guidance for Industry Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In vitro Release Testing and In vivo Bioequivalence Documentation. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), May 1997.
4. Note of guidance on oral modified release and transdermal dosage form. European agency for evaluation of medical product CPMP/EWP: 280/96, July 1999.
5. Note of guidance on pharmaceutical development ICH Q8. European agency for evaluation of medical product EMEA/CHMP/167068/2004, May 2006.
6. The United States Pharmacopoeia. 26th ed. Rockville, 1088, 2338, 2003.
7. Cardot J-M, Beyssac E. In vitro-in vivo correlations. In: Encyclopaedia of Pharmaceutical Technology 3rd ed. Informa Healthcare, 2006:2062-2072.
8. Cardot J-M, Beyssac E, Alric M. In vitro-in vivo correlation importance of dissolution in IVIVC. Dissolution Technol 2007; 14(1):15-19.
9. Gay B, Cardot J-M, Schnell C, et al. Comparative pharmacokinetics of free muramyl tripeptide phosphatidylethanolamine and muramyl tripeptide phosphatidylethanolamine entrapped in liposomes. J Pharm Sci 1993; 82:997-1001.
10. Vaughan DP, Dennis M. Mathematical basis of point-area deconvolution method for determining in vivo input functions. J Pharm Sci 1978; 67:663-665.
11. Wagner JG, Nelson E. Percent absorbed time plots derived from blood level and/or urinary excretion data. J Pharm Sci 1963; 52:610-611.