GOOD LABORATORY PRACTICES AND OTHER REGULATORY ISSUES - A REGULATORY AFFAIRS VIEW

Current international approaches differ regarding the definition of sa fety pharmacology studies, the numbers of these studies required for p roduct support and whether it is necessary to conduct these studies in conformance with Good Laboratory Practices (GLPs). The European Union currently requires conformance with GLPs, Japan has a policy allowing full raw data audits of these studies, and the FDA does not require t hat these studies conform with GLPs unless they are performed in suppo rt of studies in the toxicology package (i.e. drug safety). Although t he traditional position has been that it is impractical to conduct the se studies in conformance with GLPs, reasons for maintaining this posi tion are often incorrect and based on perception, rather than on under standing of the intent and extent of GLPs. Because it is highly possib le that safety pharmacology studies may soon be required to conform wi th GLPs, this manuscript includes a review of GIP requirements, real, rather than perceived, impediments to CLP conformance, and practical s uggestions for defining these types of specialized studies and perform ing them in such a way that they meet CLP requirments. (C) 1995 Wiley- Liss, Inc.