In vitro-in vivo correlations: general concepts, methodologies and regulatory applications.
Drug Dev Ind Pharm. 2015.
PMID: 26133085
Review.
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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 …
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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 establi …
As per the US FDA's guidance for industry entitled 'Extended Release Oral Dosage Forms: Development, Evaluation, and Application …
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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
Modeling and simulation methods are now more commonly used in drug product development and regulatory drug review. These applications include, but are not limited to: the development of biorelevant specifications, the determination of bioequivalence metrics f …
Modeling and simulation methods are now more commonly used in drug product development and regulatory drug review. These ap …
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