Global New Drug Development: An Introduction (Postgraduate Pharmacy Series)De (autor) Jan A. Rosier, Mark A. Martens, Josse R. Thomas
en Limba Engleză Carte Hardback – 19 Sep 2014
The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market.
This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious.
"This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely."
--Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)
Public țintăPrimary Market: : MSc and equivalent postgraduate courses in pharmaceutical sciences, pharmacy and industrial pharmaceutical sciences. There are now 18 universities offering Pharmaceutical Science with student number between 20 and 100 per year along with 26 pharmacy schools in the UK alone.
Typical Course Names Level Typical Student Numbers Length of Course
Pharmacy undergraduate 1000/country One semester
Pharmaceutical Technology undergraduate 1000/country One semester
Pharmacy–PhD Post graduate 50/country Three years
Pharmacy–Master Post graduate 20/country Six months
Secondary Market: Industry professionals and drug product development scientists trainees, postgraduate researchers (possibly from wider disciplines such as Pharmaceutical Medicine). Also Regulatory Bodies, Pharma, and R&D Companies and agency staff FDA, GPhC (GMC in the UK)