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Good laboratory practices and other regulatory issues: A European view
Author(s) -
Sullivan Andrew T.
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.430350306
Subject(s) - safety pharmacology , good laboratory practice , complement (music) , function (biology) , chemical safety , pharmacology , clinical pharmacology , medicine , engineering ethics , risk analysis (engineering) , business , engineering , biology , drug , pathology , biochemistry , external quality assessment , evolutionary biology , complementation , quality assurance , gene , phenotype
Safety pharmacology studies provide information on the effects of new chemical entities on physiological function in experimental animals and complement classical toxicology studies which assess effects on bodily structure. Data from these studies help to predict possible adverse effects of a compound that might be seen during administration to man, and should therefore be classified as safety studies. It is a regulatory requirement in most areas of the world that safety studies be carried out in compliance with the principles of Good Laboratory Practice. The way in which United Kingdom pharmaceutical companies approach safety pharmacology has been surveyed, and a comparison has been made with practices in the United States. © 1995 Wiley‐Liss, Inc.