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

Current international approaches differ regarding the definition of safety pharmacology studies, the numbers of these studies required for product 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 that these studies conform with GLPs unless they are performed in support of studies in the toxicology package (i.e. drug safety). Although the traditional position has been that it is impractical to conduct these studies in conformance with GLPs, reasons for maintaining this position are often incorrect and based on perception, rather than on understanding of the intent and extent of GLPs. Because it is highly possible that safety pharmacology studies may soon be required to conform with GLPs, this manuscript includes a review of GIP requirements, real, rather than perceived, impediments to CLP conformance, and practical suggestions for defining these types of specialized studies and performing them in such a way that they meet CLP requirments. (C) 1995 Wiley-Liss, Inc.