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Useful text for industry and regulatory professionals

Generic drug product development

‘Generic drug product development: solid oral dosage forms’ 2nd edition,edited by Leon Shargel and Isadore Kanfer. Ppxxii+385. Price £125. Colchester: CRC Press; 2013. ISBN 978 1420 086 355

This updated edition of ‘Generic drug product development: solid oral dosage forms’ is the latest publication in the series ‘Drugs and pharmaceutical sciences’, a range that will be recognisable to many pharmacists and researchers by its distinctive red covers. This second edition has been authored by regulatory experts from the US Food and Drug Administration (FDA) and by drug development experts from the industry and academia.

The authors diligently cover the broad area of generic drug product development, including detailed discussions on: considerations for active pharmaceutical ingredient manufacture; intellectual property; analytical method development and validation; formulation development, including quality by design; scale up; stability; quality assurance; in vitro-in vivo performance and bioequivalence; post-approval changes; adverse event reporting; and legal and legislative considerations.

Despite its fairly comprehensive scope, this book focuses mainly on FDA-related processes and therefore could not be used as a stand-alone text when worldwide regulatory matters need to be considered. And, although it is discussed briefly, this text may also have benefited from a chapter discussing in detail the particular challenges of development of generic modified-release dosage forms. Some prior knowledge of the pharmaceutical industry is assumed and most pharmacists familiar with the drug development process will find it clear and accessible. This text would be most useful for industry and regulatory professionals, but it would also provide a good reference text for pharmacy students wanting to become familiar with the considerations of generic drug development. Hospital and community pharmacists may be interested in understanding how generic drug products are developed, and the potential differences between generic and branded products.

However, the high price may restrict this text to industry professionals and university libraries. A Kindle edition is also available at a lower price, although some may find this format to be less amenable to searching for information.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11138547

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