Issues Important to in Vitro-in Vivo Correlation
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.
KeywordsUnit Impulse Manufacturing Specification Dissolution System External Prediction Numerous Topic
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