Draft ICH M13A guideline on bioequivalence open for consultation
By Giuliana Miglierini The draft ICH M13A harmonised guideline “Bioequivalence for immediate-release solid oral dosage forms” was endorsed…
The new Annex 21 to GMPs
by Giuliana Miglierini The new Annex 21 to GMPs (C(2022) 843 final) that EIPG gave a significant contribution…