GENERAL PHARMACOLOGY STUDIES IN THE PHARMACEUTICAL-INDUSTRY - EXAMPLEOF A BASIC PROGRAM

The objectives of general pharmacology (GP) studies from the point of view of pharmacologists working in pharmaceutical industry are present ed and compared with the requirements of regulatory authorities, using the Japanese Guidelines as an example. Based on these requirements, a s well as the internal requirements of other departments involved in d rug research and development, a strategy for a basic program of GP stu dies is suggested. This strategy involves the consideration of practic al aspects, animal species, route of administration, and recommended d oses. In addition, the issue of ''Good Laboratory Practice'' and wheth er this should be implemented in GP studies is discussed. In conclusio n, several areas where GP studies could be improved are indicated. (C) 1997 Wiley-Liss, Inc.