Drug Safety Evaluation


John B. Warren, Medicines Assessment Ltd, Top Flat, 25 South Audley Street, London W1K 2PB, UK. E-mail: jbwarren5@gmail.com

Drug Safety Evaluation . Jean-Charles Gautier ( ed.). Published by Humana Press , New York, USA , 2011 . 1–431 pp, price $126.30, ISBN: 1064-3745

If you are about to start a career as an animal toxicologist for a French pharmaceutical company, then this book could prove invaluable. The editor is to be congratulated on recruiting a long list of experts to write 25 useful essays on toxicology as a contribution to the Methods in Molecular Biology series. The authors work world-wide, a high proportion coming from France and North America. As toxicology text books are not in short supply, this is more a useful addition than a key text.

The title reminds me of a leading European regulator who thought the safety of medicines was evaluated in animals and efficacy in humans. Of course the best safety data come from humans and many justifications for efficacy in man come from other species. The Orwellian doublespeak is deep: the first guideline of the efficacy series from the International Conference on Harmonization, ICHE1, is actually about safety. The title of this book, ‘Drug Safety Evaluation’, might raise expectations to read of the latest exciting developments in epidemiology, law, regulation and the medical science of human pharmacology. However, the subtitle, ‘Methods and Protocols’ is some indication that this volume addresses predominately what animal experimentation is required to allow a medicine to progress to testing in man. To be fair to the book's editor, this review appears in a clinical pharmacology journal, rather than a toxicology one.

A logical approach to the topic might have been to describe the history of toxicology in the development of medicines, extended to explain how we got to where we are and what might happen in the future. Ethical concerns make the possibility of replacing many whole animal experiments with in vitro assays a hot topic worth discussing in detail. Much thought has been given worldwide to the minimum legal requirements for preclinical testing. The book would have benefited from a detailed early chapter on laws and directives, national and international guidelines, for the relevant medicines legislation. Common areas could be discussed, as well as differences between Europe, the Americas, Asia and elsewhere.

Instead part 1, under the heading ‘General Toxicology’ starts with a discussion of drug combinations followed by one on juvenile toxicity. The drug combination chapter does contain a list of ICH guidance documents for monotherapy development, but this is perhaps not an optimal approach. A chapter on drug combinations might be expected to go in depth into interactions and perhaps suggest an algorithm of how to test interactions in vitro, to keep preclinical and subsequently clinical interaction studies to a minimum.

Succeeding parts on pathology and genetic testing are on solid ground. Then a section on safety pharmacology, surely the topic of the whole book, is restricted to a single essay, though well written, confined to cardiac conduction. A section title of ‘Investigative Toxicology’ is also vague. Other sections on screening assays, proteins and biomarkers contain a wealth of useful information

In conclusion, this is more a book for the British Journal of Pharmacology rather than the British Journal of Clinical Pharmacology, a useful collection of essays, though not a comprehensive approach to drug safety.

Competing Interests

There are no competing interests to declare.


The author works as a pharmaceutical consultant for a range of pharmaceutical companies.