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In vitro-in vivo correlations: general concepts, methodologies and regulatory applications.
González-García I, Mangas-Sanjuán V, Merino-Sanjuán M, Bermejo M. González-García I, et al. Drug Dev Ind Pharm. 2015;41(12):1935-47. doi: 10.3109/03639045.2015.1054833. Epub 2015 Jul 2. Drug Dev Ind Pharm. 2015. PMID: 26133085 Review.
The major objective of in vitro-in vivo correlations is to be able to use in vitro data to predict in vivo performance serving as a surrogate for an in vivo bioavailability test and to support biowaivers. ...This article covers the basic …
The major objective of in vitro-in vivo correlations is to be able to use in vitro data to predict in vivo
In vitro/in vivo correlations in transdermal product development.
Ghosh P, Milewski M, Paudel K. Ghosh P, et al. Ther Deliv. 2015;6(9):1117-24. doi: 10.4155/tde.15.72. Epub 2015 Sep 30. Ther Deliv. 2015. PMID: 26419538 Review.
As per the US FDA's guidance for industry entitled 'Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations', in vitro-in vivo correlations (IVIVC) can be used to …
As per the US FDA's guidance for industry entitled 'Extended Release Oral Dosage Forms: Development, Evaluation, and Application of I …
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation.
Jiang W, Kim S, Zhang X, Lionberger RA, Davit BM, Conner DP, Yu LX. Jiang W, et al. Int J Pharm. 2011 Oct 14;418(2):151-60. doi: 10.1016/j.ijpharm.2011.07.024. Epub 2011 Jul 23. Int J Pharm. 2011. PMID: 21803144
These applications include, but are not limited to: the development of biorelevant specifications, the determination of bioequivalence metrics for modified release products with rapid therapeutic onset, the design of in vitro-in vivo correlations
These applications include, but are not limited to: the development of biorelevant specifications, the determination of bioequivalenc …