EN PL

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 situations where a meaningful set of CQAs can be identified, the RP should give an overview of what statistical methods for the comparison are available, and which of those might be preferred under which circumstances (e.g. number of batches available).