Scaling/Widening of AUC [Regulatives / Guidelines]

posted by dshah – India, 2021-03-16 05:39 (32 d 00:23 ago) – Posting: # 22269
Views: 411

Thank you Helmut!

I am having few doubts for harmonization.
Why regulatory bodies does have different requirement for scaling acceptance for PK parameter (Cmax and AUC) and widening limit (based on Swr/ ISCV)?
Does any regulatory have advantage over other body that their approach is superior than other body w.r.t. to efficacy and safety?
For HVD/HVDP we know that variability is bound to happen. So as per FDA- both Cmax and AUC limit can be widen, but for EMA- we cant widen AUC. So is there any safety concern database by which they are justifying that widening of limit is not permissible? or there is not safety and efficacy issue in US but it could be there EMA or other regulatory body?
Or for NTI- limit of 90.00-111.11 is more relevant than RSABE approach and does justify the safety and efficacy?
Regards,
Dshah

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