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Executive Summary

Dermatopharmacokinetic bioequivalence guidance "has had a significant number of questions in the last few months," Winkle said. "We are going back and doing some research...and we will take another look at the testing method and determine what the guidance really needs to say." The draft guidance was published in 1998 (1"The Pink Sheet" June 29, 1998, p. 24)

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