General pharmacology studies in the pharmaceutical industry: Example of a basic program

Abstract

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.