NDLI: In vitro-in vivo correlations: general concepts, methodologies and regulatory applications.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	González-García, Ignacio Mangas-Sanjuán, Victor Merino-Sanjuán, Matilde Bermejo, Marival
Description	Country affiliation: Spain Author Affiliation: González-García I ( a Department of Engineering , Area of Pharmaceutics and Pharmaceutical Technology, Miguel Hernández University , Elche , Spain .); Mangas-Sanjuán V ( b Department of Pharmaceutics and Pharmaceutical Technology , University of Valencia , Valencia , Spain , and.); Merino-Sanjuán M ( a Department of Engineering , Area of Pharmaceutics and Pharmaceutical Technology, Miguel Hernández University , Elche , Spain .); Bermejo M ( b Department of Pharmaceutics and Pharmaceutical Technology , University of Valencia , Valencia , Spain , and.)
Abstract	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. Therefore, the aims of this review are: (i) to clarify the factors involved during bio-predictive dissolution method development; and (ii) the elements that may affect the mathematical analysis in order to exploit all information available. This article covers the basic aspects of dissolution media and apparatus used in the development of in vivo predictive dissolution methods, including the latest proposals in this field as well as the summary of the mathematical methods for establishing the in vitro-in vivo relationship and their scope and limitations. The incorporation of physiological relevant factors in the in vitro dissolution method is essential to get accurate in vivo predictions. Standard quality control dissolution methods do not necessarily reflect the in vivo behavior, so they rarely are useful for predicting in vivo performance. The combination of physiological based dissolution methods with physiological-based pharmacokinetics models incorporating gastrointestinal variables will lead to robust tools for drug and formulation development, nevertheless their regulatory use for biowaiver application still require harmonization of the mathematical methods proposed and more detailed recommendations about the procedures for setting up dissolution specifications.
File Format	HTM / HTML
ISSN	03639045
Issue Number	12
Volume Number	41
e-ISSN	15205762
Journal	Drug Development and Industrial Pharmacy
Language	English
Publisher	Taylor & Francis
Publisher Date	2015-01-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Chemistry, Pharmaceutical Legislation & Jurisprudence Trends Drug Discovery Animals Biological Availability Humans Solubility Journal Article Research Support, Non-u.s. Gov't Review
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Drug Discovery Pharmacology Pharmaceutical Science

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