|  Many graduate students pursuing a unit in medicines regulation clamour
for a convenient textbook that will supplement their course notes, case
studies and visitor presentations. This ideal book should cover the specialist
topic, be up to date and clearly structured — and also relatively
cheap and readily available. Many need this holy grail in order to make
sense of, and put into clearer perspective, the plethora of ill-digested
material they uncritically download from the numerous internet sources
when striving to respond to essay assignments and dissertations without
inordinate research and value weighting or frank plagiarism. Does this
new book answer that prayer?
Two chapters explore the twin perspectives of medicines development — innovator
research and development from concept to marketing application, with
vicissitudes of candidate drugs and enormously costly attrition; and
the subsequent regulation of manufactured product. Scanty treatment of
pre-1968 control, and nothing found on the harm and detection of counterfeit
medicines, could be remedied within a lecture programme.
The Common Technical Document is conveniently summarised — although
one would have welcomed brief correlation of the Quality Overall Summary
(§2.3) with Module 3 “Quality”. Later chapters incorporate
composite listing of EU guidance on pharmaceutical development and on
clinical testing, the roles of UK and European agencies, and a useful
exposition of the National Institute for Clinical Excellence. The book
concludes with the evolution and guidance of international conferences
on harmonisation and designedly brief mention of the US Food and Drug
Administration and the World Health Organization.
That this book is less of a prose work than a series of succinct statements
and associate tabulation is not a criticism — but rather an endorsement.
It could provide what
graduate students want to supplement their regulatory courses, although
it is more in the price range of a regulatory affairs scientist wanting
to check a position without reading a chapter.
Geoffrey Phillips
|
The
Pharmaceutical Journal