drug development perspectives considerations, challenges, and strategies

Book review

Drug development perspectives considerations, challenges, and strategies

Nuggehally Srinivas. Published by HNB Publishing, New York, 2010. 328 pp, price $99.97, ISBN: 978-0-9664286-9-8

The falling productivity of the global pharmaceuticalindustry is a matter of record and a concern for thoseboth within industry and in the life science sector morebroadly. Seeking to reverse this trend, industry is lookingmuch more widely for sources of innovation, movingaway from a centralized closed innovation model. As aresult those in drug development are tending to work inmuch smaller groups on novel targets with individualstaking much wider responsibility for multiple aspects ofearly drug development. A book that provides a broadoverview with relevant examples is potentially very valu-able to those working in this environment. Dr Srinivas hasover 20 years experience in many phases of early drugdevelopment and has published widely. In this book hehas selected five areas for detailed review: bioanalysis,allometry, CYP metabolism, PK simulations, drug combina-tions and genetic polymorphisms. Selection of thesetopics seems to have been driven by the availability ofsuitable examples. An introductory section on why thesehave been selected and how they fit into an overall drugdevelopment plan would have been helpful. Each chapterfollows the same general plan: an introduction, a series ofdetailed examples, and a concluding summary section.The summary sections at the end of the chapter are thebest feature of the book and provide useful practical andstrategic insights. Unfortunately some of the detailedexamples seem to reflect the information available on thesubject drug rather than addressing specific aspects rel-evant to the chapter. As a result some of the key messagesare lost in the detail. The introductory sections are rathershort and serve more as a summary of the information inthat chapter rather than an overview of the topic. This is aparticular weakness as the topics are highly selected andreaders new to drug development will need more infor-mation on the other tools or techniques available toaddress the question in hand. For example the chapter onallometry discusses the strengths and weaknesses of thistechnique but has very little information on what other

options are available for human PK prediction. This isimportant because allometry is no longer widely used asthe primary method for human PK prediction. It may bebeyond the scope of this book to discuss detailed alter-native examples but an outline of key concepts such asthe minimal anticipated biological effect level (MABEL)would provide important context for readers.

Overall this book provides a useful reference for thoseseeking specific examples to illustrate identified issues indrug development but it lacks the broad overview andguidance for it to be used as a practical guide to drugdevelopment.

Competing Interests

There are no competing interests to declare.

Duncan RichardsClinical Director, Academic DPU, GSK R&D, Cambridge

RECEIVED18 March 2011

ACCEPTED21 March 2011

ACCEPTED ARTICLE29 March 2011

CORRESPONDENCEDr Duncan Richards, Clinical Director, GSK Academic DPU,Addenbrookes Hospital, Hills Road, Cambridge CB2 2GG, UK.E-mail: duncan.b.richards@gsk.com

British Journal of ClinicalPharmacology

DOI:10.1111/j.1365-2125.2011.03975.x

172 / Br J Clin Pharmacol / 72:1 / 172 © 2011 The AuthorBritish Journal of Clinical Pharmacology © 2011 The British Pharmacological Society