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.
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© 1997 Plenum Press, New York
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Young, D., Devane, J.G., Butler, J. (1997). Issues Important to in Vitro-in Vivo Correlation. In: Young, D., Devane, J.G., Butler, J. (eds) In Vitro-in Vivo Correlations. Advances in Experimental Medicine and Biology, vol 423. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-6036-0_26
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DOI: https://doi.org/10.1007/978-1-4684-6036-0_26
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4684-6038-4
Online ISBN: 978-1-4684-6036-0
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