Book Review pubs.acs.org/OPRD
Specifications of Drug Substances and Products: Development and Validation of Analytical Methods and three easy to read and informative. As can be expected with the constantly changing regulatory environment, some comments appeared to be a little out of date (e.g., elemental impurities), but this did not have significant negative impact on the content. Since much of my career has revolved around early phase development projects, I found these chapters especially interesting to confirm my understanding of the downstream needs heading toward commercialisation of drug substances. This, coupled with part four where the drug product is discussed, was especially interesting to me. I suggest chemists pay close attention to chapter five (appearance testing and its subjectivity) and chapter nine (solid state characterisation, for instance, challenges with limits of detection in polymorph content). From a more practical point of view, the contents are well set out, and indexing appeared appropriate. Although all diagrams and tables are in black and white, they are clear, easy to follow, and located close to the relevant text. A glossary of terms may have been a useful addition as many acronyms appear in the book, but a quick look back to the index confirms the meaning of any acronym. Overall, this book is a valuable addition to a pharmaceutical scientists’ library. The topics covered are relevant and of interest to various “stake-holders” in the drug development arena, including chemists, analysts, and programme managers. I can recommend it.
Specifications of Drug Substances and Products: Development and Validation of Analytical Methods. C. M. Riley, T. W. Rosanske, and S. R. Rabel Riley, Eds.; Elsevier Ltd.: New York, September 2013. 364 pp plus index. £72.99. ISBN 978-008-098350-9 (hard back).
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he editors have used 26 contributors to compile what is a very interesting overview on the subject of establishing specifications for drug substances and drug products. I found this a very topical, relevant, easy, and interesting book to read. Although there are 26 contributors, there appeared to be a consistent and authoritative writing style in which the personal experiences of contributors came through. Thus, the style helped make the book more accessible to meI am a chemist and not an analyst yet found the content interesting and informative. Of particular interest to me was the consideration throughout the book to early phase development projects as this can so often present challenges since the regulatory guidelines are, for the most part, geared for marketed products (or those nearing market launch). The book contains 16 chapters and is arranged in seven separate parts. Part one (chapters one to four) gives a very nice introduction with chapter one setting the scene followed by chapter two providing regulatory considerations for setting specifications. Chapter three was especially interesting to me as it discussed the application of Quality by Design (QbD) in analytical method development. It provides basic comments about Design of Experiments (DoEs) and their design and implementation, giving some very clear tips about the order of events. In particular the chapter has a section devoted to general advice on the design and analysis of experiments. The chapter also has a case study and helpful conclusions about QbD, knowledge management, and lifecycle of analytical methods, which leads into chapter four. Chapter four moves on to general principles and regulatory considerations for method validationa really useful chapter for chemists and probably less experienced analysts; the chapter provides an outline of validation, for instance, for HPLC methods. It then goes on to discuss staged approaches to method validation and the pitfalls associated with trying to fully validate methods in early development, where changes to manufacturing processes may impact the analytical methods forcing complete revalidation. There are also helpful suggestions for method transfer. As with other chapters, this strongly conveys a sense of having been written by an experienced (and perhaps scarred) practitioner. Parts two to seven of the book then discuss topics in more detail, covering universal tests and specific tests for drug substance and specific tests for drug products, followed by a discussion of pharmacopoeial methods, and closing with microbial methods and an analysis of biological fluids. The focus of my reading was parts two and three since these related to drug substance; I then dipped into segments of the later parts. As with part one, I found the chapters in parts two © 2014 American Chemical Society
John Knight
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Scientific Update LLP, Maycroft Place, Stone Cross, Mayfield TN20 6EW, U.K.
AUTHOR INFORMATION
Notes
The authors declare no competing financial interest.
Published: September 11, 2014 1154
dx.doi.org/10.1021/op5002879 | Org. Process Res. Dev. 2014, 18, 1154−1154
