MODULE 10: PHARMACOVIGILANCE

MODULE 10: PHARMACOVIGILANCE WHO/Petterik Wiggersn1681. INTRODUCTIONThis section introduces the concepts of PHARMACOVIGILANCE and adverse drug reactions, discusses the burden of adverse drug reactions for children and explains the importance of PHARMACOVIGILANCE in the context of antiretroviral therapy (ART). Defining pharmacovigilanceWHO defines PHARMACOVIGILANCE as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem (1). It focuses on investigating and monitoring adverse drug reactions after medicinal products are licensed (2). Adverse drug reactions are a response that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease or for modifying physiological function (2). They may vary in presentation and occurrence and are commonly divided into type A (augmented pharmaceutical response) and type B (bizarre or hypersensitivity) adverse drug reactions (3).

of drug development, from initial research and development activities to final consumer use and is commonly divided into two stages (Fig. 10.1): pre-marketing surveillance: adverse drug reactions from preclinical screening and Phase I, II and III clinical trials; and post-marketing surveillance: adverse drug

Loading..

Tags:

  Development, Preclinical

Information

Related search queries