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Final Product Testing and the Development of Specifications for Veterinary Pharmaceuticals

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Long Acting Animal Health Drug Products

Part of the book series: Advances in Delivery Science and Technology ((ADST))

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Abstract

This chapter reviews the main concepts related to analytical testing of veterinary drug products and the development of specifications for critical quality attributes. Pragmatic strategies for the development and use of analytical specifications throughout the veterinary product development and commercialization life cycle are discussed. Also presented are typical analytical testing requirements for quality assessment and registration of selected types of products in major markets (USA, EU, and Japan), and unique challenges related to several veterinary-centric dosage forms including medicated articles for preparation of feeds and drinking waters, and topical parasiticide preparations.

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Acknowledgements

Many thanks to the following Merck Animal Health colleagues for their valuable discussions and review of this chapter: Dr. Richard Endris, Mr. Keith Freehauf, Mr. John Hayes, Dr. Shannon Higgins-Gruber, and Mr. Randal Schapaugh.

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  1. Merck Animal Health, Summit, NJ, USA

    Jay C. Brumfield

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  1. Jay C. Brumfield
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Correspondence to Jay C. Brumfield .

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  1. Division of Pharmacy, International Medical University, #126 Jalan Jalil Perkasa 19, Bukit Jalil, Kuala Lumpur, 57000, Malaysia

    Michael J. Rathbone

  2. , New Zealand's National School of Pharmac, University of Otago, Dunedin, 9054, New Zealand

    Arlene McDowell

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Brumfield, J.C. (2013). Final Product Testing and the Development of Specifications for Veterinary Pharmaceuticals. In: Rathbone, M., McDowell, A. (eds) Long Acting Animal Health Drug Products. Advances in Delivery Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-4439-8_8

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