1、 RegMed 2018 Vol. 88 26 EMA 2017 6 (NORs) (PARs) (DSp) EMA 2017/06/06 Normal operating range (NOR) 、 Proven acceptable range (PAR) Design space (DSp) Questions and answers: Improving the understanding of NORs, PARs, DSp and normal variability of process parameters 1. (Normal Operating Range, NOR) (m
2、arketing authorization dossier) (NOR) ICH NOR (target operating condition) NOR NOR 2. (Proven Acceptable Range, PAR) PAR (1) (PAR) PAR (NOR) PAR PAR (2) PAR PAR (3) PAR PAR 3. (Design Space DSp) RegMed 2018 Vol. 88 27 (1) (DSp) ( ： ) (2) / (NOR) (3) 4. (1) (extension) (Type II variation) A. B. (2) (3) / Type IA IB (criticality) 5. NORs PARs DSp (process flexibility)
