In vitro–In vivo Relationship and Bioequivalence Prediction for Modified-Release Capsules Based on a PBPK Absorption Model

Author:

Jereb RebekaORCID,Opara Jerneja,Legen Igor,Petek Boštjan,Grabnar-Peklar Darja

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference25 articles.

1. Emami J. In vitro – in vivo correlation: from theory to applications. J Pharm Pharmaceut Sci. 2006;9(2):31–51.

2. Food and Drug Administration. Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlations [Internet]. 1997. Available from: https://www.fda.gov/media/70939/download. Accessed 31 May 2019.

3. European Medicines Agency. Guideline on quality of oral modified release products [Internet]. 2014. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-oral-modified-release-products_en.pdf. Accessed 31 May 2019.

4. European Medicines Agency. Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms [Internet]. 2014. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf. Accessed 31 May 2019.

5. Nguyen MA, Flanagan T, Brewster M, Kesisoglou F, Beato S, Biewenga J, et al. A survey on IVIVC/IVIVR development in the pharmaceutical industry—past experience and current perspectives. Eur J Pharm Sci. 2017;102:1–13. https://doi.org/10.1016/j.ejps.2017.02.029.

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