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.
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Acknowledgements
The author thanks M/s Bharat Biotech International Limited, Hyderabad, India, for providing the opportunity to work on this project and giving permission to publish this work in this book.
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Murthy, G.S.R. (2015). A Statistical Procedure for Minimizing In Vivo Tests for Quality Control of Vaccines. In: Applications of Operations Research and Management Science. International Series in Operations Research & Management Science, vol 229. Springer, Cham. https://doi.org/10.1007/978-3-319-17921-6_3
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DOI: https://doi.org/10.1007/978-3-319-17921-6_3
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