Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999

Issue Date: April 11, 2003
Issued by: Center for Drug Evaluation and Research
Topic(s): Biopharmaceutics, Generic Drugs
Status: Draft

Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999

Statistical analysis method recommendations for in vitro nonprofile bioequivalence data, to accompany the draft guidance for industry entitled Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (April 2, 2003), are under development. At a later time, the analysis methods will be posted. Until these methods are prepared, two documents, both in need of updating, are being made available in the present document. These documents are the original statistical information taken from the earlier June 1999 draft of this guidance, and also from the added Statistical Information for In Vitro Bioequivalence Data material posted on August 18, 1999. The subsequent implementation will include the estimation of within canister (between life stage) component of variance.

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