PQRI Workshop Report: Application of IVIVC in Formulation Development

Abstract

This article summarizes the proceeding of the September 2012 Workshop on Application of In vitro–In vivo correlation (IVIVC) in Formulation Development. The workshop brought together international experts with the goal of establishing common concepts that could be utilized to facilitate the development and validation of IVIVCs in the registration of and post-approval changes to oral solid dosage forms. The workshop was organized by the Product Quality Research Institute (PQRI) and cosponsored by AAPS, FDA, FIP, and USP. Open access of this information is available to all interested parties. INTRODUCTION IVIVC is an important concept and a tool in the development and evaluation of pharmaceutical dosage forms. A properly conducted IVIVC provides assurance of the robustness of a dosage form and provides justification of manufacturing changes during drug product development. A filed IVIVC can accelerate internal decision making of proposed SUPAC changes by providing linkage back to preapproval formulations. As such, a well-conducted IVIVC may have substantial value to pharmaceutical manufacturers, regulatory bodies, and ultimately, consumers of the product. Early history (1982–1992) suggests that few IVIVCs were filed. Since the advent of the FDA guidance (1) approximately fifteen years ago, the number of NDAs containing IVIVC studies has increased, and it is anticipated that exploration of IVIVCs and IVIVRs will continue to grow. FDA scientists confirmed that most IVIVCs filed are for modified-release (MR) products with fewer for immediaterelease (IR) dosage forms. Many of the latter were identified as insufficient and not approvable. Early statistics immediately following the issuance of the FDA Guidance *Corresponding author. e-mail: vanbuskirk@drugdevconsult.com dx.doi.org/10.14227/DT210214P51