Advertisement

Issues Important to in Vitro-in Vivo Correlation

IVIVR Workshop Open Discussion
  • David Young
  • John G. Devane
  • Jackie Butler
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 423)

Abstract

Although this book addresses numerous topics in the area of in vitro-in vivo correlation (IVIVC), this chapter summarizes some of the scientific and regulatory issues important to IVIVC and the Draft FDA Guidelines on IVIVC. This chapter was based on the open discussion sessions at the IVIVR Workshop in Baltimore, Maryland on September 4–6, 1996. The chapter represents a compilation of comments and the consensus of the attendees at the meeting. This chapter is organized into five major topics with each issue listed under the topic and the consensus response from the attendees. For those few times that a consensus could not be reached, the different points of view are provided.

Keywords

Unit Impulse Manufacturing Specification Dissolution System External Prediction Numerous Topic 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Copyright information

© Plenum Press, New York 1997

Authors and Affiliations

  • David Young
    • 1
  • John G. Devane
    • 2
  • Jackie Butler
    • 2
  1. 1.University of Maryland at BaltimoreBaltimoreUSA
  2. 2.Elan Corporation, plcAthloneIreland

Personalised recommendations