A Statistical Procedure for Minimizing In Vivo Tests for Quality Control of Vaccines

G. S. R. Murthy
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G. S. R. Murthy: Indian Statistical Institute

Chapter Chapter 3 in Applications of Operations Research and Management Science, 2015, pp 37-49 from Springer

Abstract: Abstract Biotechnology and pharmaceutical industries are required to use in vivo tests, in addition to in vitro tests, for drug evaluation. These in vivo tests are carried out on nonhuman animals, and drug regulating authorities insist on rigorous animal testing before issuing license for human use. For various reasons (Wales, Animal testing. http://en.wikipedia.org/wiki/Animal_testing ), there is a global move towards minimizing the in vivo tests. This article presents a case study carried out at M/s Bharat Biotech International Limited, Hyderabad, on minimizing in vivo tests for evaluating efficacy of recombinant Hepatitis B vaccine produced by the company. Exploring the past data using different statistical methods, the study recommends a statistical procedure to assess the efficacy of the vaccine produced in each batch based on in vitro test result and provides a decision rule on when to conduct in vivo test. The benefits of the study are discussed. The approach suggested in this work may be extended to similar cases where in vivo tests are involved. It is hoped that this study will be contributing to the cause of minimizing in vivo tests.

Keywords: Relative Potency; Partial Waiver; Past Data; Recombinant Hepatitis; National Regulatory Authority (search for similar items in EconPapers)
Date: 2015
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DOI: 10.1007/978-3-319-17921-6_3

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