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Safety pharmacology program for pharmaceuticals
Author(s) -
Kinter Lewis B.,
Dixon Lon W.
Publication year - 1995
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/ddr.430350312
Subject(s) - safety pharmacology , clinical pharmacology , medicine , pharmacology , risk analysis (engineering) , computer science , business , drug
Safety pharmacology data is used by clinicians, toxicologists, discovery scientists, and regulators involved in developing and registering new pharmaceutical products. We recently developed a safety pharmacology program to meet the needs of these diverse customer groups at Sterling Winthrop. We identified three classes of safety pharmacology studies: Core (cardiovascular, respiratory, renal, and CNS), having the broadest value to all customers; Special (ocular, auditory, etc.), occasionally needed to address compound or class effects; and Ancillary (GI, autonomic, behavioral), needed to complete international registration requirements. We established a tiered approach to the conduct of these studies that is efficient and cost‐effective, and developed general guidelines for designs of Core studies. The proposed program meets or exceeds all international regulatory requirements and insures that the necessary results are available for each customer group within the time frame that the data are most useful. © 1995 Wiley‐Liss, Inc.