Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

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Current effective version

Adopted guideline

Revision 1 enters into effect 01/02/2018 - see below

Reference numberCHMP/SWP/28367/07
Published19/07/2007
Effective from01/09/2007
KeywordsFirst-in-human, phase I clinical trials, identification of risk, non-clinical requirements, animal models, minimal anticipated biological effect level (MABEL), risk mitigation strategies
DescriptionThis document addresses non-clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also addresses the design and conduct of trials in the initial phase of single and ascending doses during the clinical development.


Document history

Revision 1

 

Adopted guideline
 

 

Overview of comments

 

Draft guideline
 

Concept paper

 

Overview of comments

Published: 25/07/2017
Coming into effect: 01/02/2018

 

Published: 27/09/2017

 

Published: 15/11/2016
 

Published: 21/07/2016

 

Published: 27/09/2017

First version

Current version

Adopted guideline


 

Overview of comments


 

Draft guideline

In operation: 01/09/2007–present


 

Published: 03/05/2007


 

Published: 22/03/2007


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