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General pharmacology studies in the pharmaceutical industry: Example of a basic program
Author(s) -
Pairet Michel,
Diederen Willi,
Guth Brian,
Kanai Kozo,
Mauz Annerose,
Pieper Michael,
van Ryn Joanne,
Schierok Hans,
Walland Alexander,
Winquist Ray
Publication year - 1997
Publication title -
drug development research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.582
H-Index - 60
eISSN - 1098-2299
pISSN - 0272-4391
DOI - 10.1002/(sici)1098-2299(199710)42:2<57::aid-ddr1>3.0.co;2-o
Subject(s) - pharmaceutical industry , clinical pharmacology , pharmacology , safety pharmacology , drug , drug industry , medicine , drug development , business , risk analysis (engineering) , management science , engineering ethics , engineering
The objectives of general pharmacology (GP) studies from the point of view of pharmacologists working in the pharmaceutical industry are presented and compared with the requirements of regulatory authorities, using the Japanese Guidelines as an example. Based on these requirements, as well as the internal requirements of other departments involved in drug research and development, a strategy for a basic program of GP studies is suggested. This strategy involves the consideration of practical aspects, animal species, route of administration, and recommended doses. In addition, the issue of “Good Laboratory Practice” and whether this should be implemented in GP studies is discussed. In conclusion, several areas where GP studies could be improved are indicated. Drug Dev. Res. 42:57–62, 1997. © 1997 Wiley‐Liss, Inc.