Biowaivers Proposed For Highly Permeable, Soluble, Rapidly Dissolving Drugs
Executive Summary
FDA is proposing to grant waivers of in vivo bioequivalence tests for certain immediate-release solid oral dosage form drugs that meet the characteristics of being highly permeable, soluble and having rapid dissolution.
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Bioequivalence Requirements Could Be Reduced By Question-Based Review
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Bioequivalence Requirements Could Be Reduced By Question-Based Review
A question-based review emphasizing quality by design could reduce the need to conduct bioequivalence studies for highly variable drugs, FDA said at a meeting of the Advisory Committee for Pharmaceutical Science on May 4
Biopharmaceutical classification
Final FDA guidance should issue in the next few weeks, Office of Pharmaceutical Science Acting Director Helen Winkle said May 15 at the National Association of Pharmaceutical Manufacturers mid-year meeting in Newark, N.J. Center for Drug Evaluation & Research Director Janet Woodcock, MD, "has already signed the guidance," Winkle said. A training session will be held June 19. The draft was published in February 1999 (1"The Pink Sheet" Feb. 22, 1999, p. 24)