News|Articles|March 1, 2002

Pharmaceutical Technology

  • Pharmaceutical Technology-03-02-2002
  • Volume 26
  • Issue 3

Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method Transfer

This article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.


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Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.