ICH Guidelines- “E” Series (Efficacy Guidelines) -A Review

Author(s): K. Bhavyasri*, R. Sai Chandana, M. Sumakanth and D. Rambabu

Abstract: ICH-International conference on harmonization of technical requirements for registration of pharmaceuticals for human use is a joint initiative involving both regulatory and research based industry representatives of Europe, Japan and US in scientific and technical discussions of the testing procedure which is required to assess and ensure the efficacy, quality and safety of medicines. The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials in human subject like dose response studies, good clinical practices (GLP). It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics / pharmacogenomics techniques to produce better targeted medicines.

PAGES: 1052-1059  |  190 VIEWS  306 DOWNLOADS