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Bioequivalence testing

Executive Summary

Strategy for bioequivalence testing of highly variable drug products will be discussed by FDA's Pharmaceutical Science Advisory Committee on April 14. On April 13, the committee will discuss a proposal for resolving issues related to the parametric tolerance interval test for dose content uniformity for inhalation products. The committee will also receive updates from the Clinical Pharmacology Subcommittee and on the progress of FDA's process analytical technologies effort. [To 1watch a webcast of this meeting, go to FDAAdvisoryCommittee.com]....

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