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Clinical pharmacological evaluation in drug control : ensuring quality of clinical trials : report from the 19th European Symposium, Bad Neuenahr, Germany 12-13 December 1995
(EUR/ICP/DRVE 94 01/MT 01, 1996)Clinical trials are an essential step in the development of safe and efficacious new drugs. Registration of new drugs in future could depend on mutual recognition of such trials. They must therefore be of high quality and adhere to high ethical standards. This can be assured through the application of good clinical practice procedures incorporating strict requirements for ethical conduct, quality assessment and high scientific standards. The personal rights of volunteers and patients in clinical trials must be protected. Countries with no experience ...
