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CONDUCT OF EXPLORATORY CLINICAL TRIALS
This paper will focus on the new possibilities of obtaining more pharmacology data earlier in the drug development process from a regulatory perspective, and will also present the experience of SGS Antwerp Clinical Pharmacology Unit. It is worthy to mention that the Belgium Guidelines and the recently released Revision 2 of the Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3) are comparable.
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