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

In: Applications of Operations Research and Management Science

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  • G. S. R. Murthy

    (Indian Statistical Institute)

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.

Suggested Citation

  • G. S. R. Murthy, 2015. "A Statistical Procedure for Minimizing In Vivo Tests for Quality Control of Vaccines," International Series in Operations Research & Management Science, in: Applications of Operations Research and Management Science, edition 127, chapter 0, pages 37-49, Springer.
    • Handle: RePEc:spr:isochp:978-3-319-17921-6_3
    DOI: 10.1007/978-3-319-17921-6_3
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