Review of the book “Arzneimittel-Entwicklung und Zulassung” (drug development and market authorization)

Written by Dr. Janet Thode on . Posted in Think out of the box

And once again a technical book accompanied me on vacation and aided in avoiding my gray matter to rust completely ;-)

I’d like to use this blog article to describe my impressions of the book “Drug Development and Market Authorization” by Niels Eckstein (2nd edition from 2018, published by Deutscher Apotheker Verlag Stuttgart, ISBN: 978-3-7692-6992-5).

Regarding the content, the institutions involved in pharmaceutical law, the structure of the common technical document used for submission and the various types of authorization procedures are of course presented. Brand new in the current COVID-19 situation and after the recent announcement of BioNTech’s vaccine is of course the conditional marketing authorization... The book also contains very good information about the preclinical and clinical studies. Unfortunately, however, it also covers a lot of topics that, in my opinion, have nothing or only marginally to do with the title of the book. E.g. Excursions into pharmaceutical logistics, biostatistics, evidence-based medicine, pharmacovigilance and health care are made. Don't get me wrong, it is quite interesting to learn how billing of medication is performed by health insurances... However, due to the title of the book I expected more and I am a little bit disappointed that authorization and regulatory relevant background information make up only half of the book and that the field of drug development is completely missing... I learned a lot, but I expected something else.

Apart from that, the book in general is very interesting and easy to understand. Didactically, it scores with highlighted memo and definition boxes, appropriate tabulation and illustration and some (but very nice) practical examples for exemplification (there could be more of them). Also very nice is a short introduction at the beginning of each chapter, which prepares the reader for the upcoming content and arouses his or her curiosity. In addition, the book is completed by a list of abbreviations, a glossary, an overview of further literature and a list of all ICH guidelines. This ICH guideline listing would not have been necessary in my opinion. It appears a bit like being a page filler; a link to the website would have been enough and optionally a half-page summary of the 4 areas. Apropos summary: Unfortunately, this book doesn’t contain any crisp summaries at the end of the respective chapters, but I admit that this would be a real challenge depending on the content due to the wealth of information ;-)

I had to smile a bit when I read something about Readability Testing in the morning (this is the patient's review of the understandability of the package insert) and during a conference call with a client in the afternoon, I heard that in the current project a risk assessment has been performed leading to the introduction of special warning notices in the package insert...

The book can be recommended to all pharmacy students who will graduate soon and who would like to get an impression of a possible field of activity but also to newcomers who have accepted a job in the regulatory department and who would also like to learn some "surroundings“.

Tags: recension

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