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The guideline is intended to assist sponsors in the transition from
non-clinical to early clinical development. It identifies factors
influencing risk for new investigational medicinal products (IMPs) and
considers quality aspects, non-clinical and clinical testing strategies and
designs for first-in-human clinical trials. Strategies for mitigating and
managing risk are given, including the calculation of the initial dose to be
used in humans, the subsequent dose escalation, and the conduct of the
clinical trial.
This guideline should be read in conjunction with the respective published
EU guidelines and applies to all new chemical and biological investigational
medicinal products except gene and cell therapy medicinal products. It
covers non-clinical issues for consideration prior to the first
administration in humans and the design and conduct of trials in the initial
phase of single and ascending doses during the clinical development.
The Guideline can be found at
http://www.emea.europa.eu/pdfs/human/swp/2836707enfin.pdf
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