A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions.

Abstract

INTRODUCTION Parts A and B of the ICH S7 guidelines on safety pharmacology describe the in vivo studies that must be conducted prior to first time in man administration of any new pharmaceutical. ICH S7A requires a consideration of the sensitivity and reproducibility of the test systems used. This could encompass maintaining a dataset of historical pre-dose… (More)
DOI: 10.1016/j.vascn.2013.04.008

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