News|Articles|September 2, 2005

Pharmaceutical Technology

  • Pharmaceutical Technology-09-02-2005
  • Volume 29
  • Issue 9

Analytical Method Equivalency: An Acceptable Analytical Practice

Participants in a 2003 PhRMA workshop present the industry’s current thinking on developing analytical method equivalency, including the importance of sample selection, acceptance criteria, data evaluation, and documentation.

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Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation. | Image Credit: ©HockleyMedia24/peopleimages.com -stock.adobe.com
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.