Abstract
Because of the multinational nature of the pharmaceutical industry, the methods used to obtain marketing approvals for Glaxo products are most effective when they meet the scientific and ethical requirements of the major markets for which they are targeted. In most instances, the optimal course is to develop universally acceptable data proving the safety and efficacy of the products. The acceptance of Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs) concepts, as developed by the US Food and Drug Administration, has helped to establish continuity in the conduct and reporting of preclinical and clinical research. As similar regulatory requirements are adopted in Great Britain, Europe, Japan, Scandinavia, and other major markets, Glaxo is challenged to identify and develop appropriate methods and procedures to assure the quality and integrity of research data and submissions. This presentation outlines methods used at Glaxo to assure consistency in research methods and results and complian...
Published Version
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