Drug development ethics committees

The FETAX has been in use as a screening test in our laboratory since 1999 and is based on the standard guide of the American Society for Testing and Materials (1). FETAX is conducted under the approval of our local ethical committee using Xenofus laevis embryos and constitutes an efficient developmental toxicity screening test when performed early in drug safety development. Its possible use as a mechanistic model is not discussed herein. 

Studies in special groups pose similar ethical problems to those in healthy young adult subjects, but there are additional concerns, for example, with trials in children and the very elderly. The ICH has done much to gain a commonality of approach to drug development in those groups, and many are also in line with Committee for Proprietary Medicinal Products (CPMP) guidelines. 

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