Time Scaling for In Vitro-In Vivo Correlation: the Inverse Release Function (IRF) Approach

Author:

Cardot Jean Michel,Lukas John C,Muniz Paula

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference15 articles.

1. Guidance for industry extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. FDA CDER September 1997a. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm070239.pdf

2. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1). CHMP November 2014a (replacing Guideline on Modified Release Oral and Transdermal Dosage Forms Section II (Pharmacokinetic and Clinical Evaluation (EMA/CPMP/EWP/280/96 Corr1)). Available at: http://www.ema.europa.eu /docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177884.pdf.

3. Guidance for Industry SUPAC-MR: modified release solid oral dosage forms. FDA CDER September 1997b. Available at: https://www.fda.gov /downloads/Drugs/Guidances/ucm070640.pdf.

4. Guideline on quality of oral modified release products. CHMP March 2014b. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/07/WC500170465.pdf

5. Roudier B, Davit B, Schütz H, Cardot JM. Impact of data base structure in a successful in vitro-in vivo correlation for pharmaceutical products. AAPS J. 2015;17(1):24–34. https://doi.org/10.1208/s12248-014-9680-x .

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