EMEA Publishes Guideline on Strategies to Identify and Mitigate Risks in first-in-human Clinical Trials with IMPs

GMP News
22 August 2007
 

EMEA Publishes Guideline on Strategies to Identify and Mitigate Risks in first-in-human Clinical Trials with IMPs

 
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 
  

Hear essential aspects about the organisation and management of clinical trials, IMP distribution and things to consider during the study in the ECA Education Course

During this course, the important interfaces between GMP and GCP will be elaborated.

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
 

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