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EMA: Draft guideline on the investigation of subgroups in confirmatory clinical trials

06.02.2014
Investigation into the effects of treatment in well-defined subsets of the trial population is an integral part of clinical trial planning, analysis and inference that follows the inspection of ...

EMA: Concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

23.01.2014
In the recent past, several requests submitted for EMA scientific advice contained questions concerning the adequacy of planned inferential statistical approaches to compare quality attributes.For ...

EMA: Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

04.07.2013
The reflection paper (RP) should provide an overview of statistical principles with a potential of useful application in the context of the comparison of quality attributes as mentioned above. For ...

EMA: Concept paper on extrapolation of efficacy and safety in medicine development

25.04.2013
The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine ...

EMA: Concept paper on extrapolation of efficacy and safety in medicine development

05.07.2012
This concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine ...

EMA: Concept paper on the need to revise the points to consider on adjustment for baseline covariates

01.03.2012
The Committee for Medicinal Products for Human Use points to consider on adjustment for baseline covariates came into operation in 2003. Since then, they have been widely used by both industry and ...