Transcription of Reflection paper on statistical methodology for the ...
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Reflection paper on statistical methodology for the ...
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 26 July 2021 EMA/CHMP/138502/2017 Committee for Medicinal Products for Human Use (CHMP) Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development Draft agreed by Biostatistics Working Party Fe bruary 2017 Adopted by CHMP for release for consultation 23 March 2017 Start of public consultation 01 April 2017 End of consultation (deadline for comments) 31 March 2018 Agreed by Biostatistics Working Party June 2021 Adopted by CHMP 22 Ju ly 2021 Keywords Stat
from comparative dissolution experiments. In situations where pivotal evidence for similarity comes from comparative statistical analyses of clinical data, there is an established methodological framework in place, based on drawing inferences from samples (patients or healthy subjects). This involves agreed methods to justify equivalence limits
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