In Vitro–In Vivo Correlation (IVIVC): A Strategic Tool in Drug Product Development

Abstract

In a recent era many concepts are dealing as an emerging tool for the drug delivery application like Biopharmaceutical Classification System (BCS), In vitro and In vivo study, and Bioavailability/Bioequivalence (BA/BE) study etc. To determine Therapeutic efficiency in vitro is not enough so the concept of In vitro-In vivo correlation (IVIVC) is playing as an convincing correlation with this for concept of pharmaceutical dosage forms have been a main focus of attention of pharmaceutical industry, academia, and regulatory sectors. Formulation, Development and optimization of dosage form is an integral part of research governed by technology transfer to scale up the manufacturing and then concurrent validation governed from the marketing of any therapeutic agent which is indeed a time consuming and costly process. A good correlation is a tool for predicting in vivo results based on in vitro data using IVIVC which gives indirect cost effective approach to dosage form optimization of trials in human, fixes dissolution acceptance criteria, and can be used as a tool to substitute for further bioequivalence studies. IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies during the formulation development as the main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability and to support biowaivers. This review article represents the FDA guidance, development, evaluation, and validation of an IVIVC to grant biowaivers, and to set dissolution specifications for oral dosage forms, biopharmaceutical classification systems (BCS), BCS biowaivers, and applications of BCS in IVIVC development and concept of mapping. The importance of dissolution media and methodology and pharmacokinetic studies in the context of IVIVC has been highlighted. The principles of IVIVC also merged with nonoral products such as parenteral depot formulations and novel drug delivery systems as well.

Keywords: Fundamentals of IVIVC, Biopharmaceutical Classification System (BCS), Objectives, Biowaiver, Levels, Correlation, Dissolution methodologies, IVIVC of Novel Dosage Forms, Applications of IVIVC

Cite this Article

Vivek P. Chavda, Dhaval Shah, Hemal Tandel et al. In Vitro–In Vivo Correlation (IVIVC): A Strategic Tool in Drug Product Development. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(3): 31–54p.