A graphical representation for a statistical test of average equivalence and variance comparison with process data

Author:

Burdick Richard K.,Pferdeort Valerie,Sidor Leslie,Tholudur Arun

Publisher

Wiley

Subject

Management Science and Operations Research,Safety, Risk, Reliability and Quality

Reference5 articles.

1. ICH Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 2005

2. Analytical method equivalency: An acceptable analytical practice;Chambers;Pharmaceutical Technology,2005

3. Beyond the t-test: Statistical equivalence testing;Limenati;Analytical Chemistry,2005

4. A method for determining equivalence in industrial applications;Richter;Quality Engineering,2002

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2. A Risk-Based Approach to Setting Acceptance Criteria for Pharmaceutical Process Comparability;Journal of Pharmaceutical Innovation;2017-10-16

3. Analytical Comparability and Similarity;Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry;2017

4. Jackknife empirical likelihood method for testing the equality of two variances;Journal of Applied Statistics;2014-07-14

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