Bioequivalence and Bioavailability Forum • Bioequivalence

Sriraj
☆

India,
2010-01-26 13:03
(5998 d 19:54 ago)

Posting: # 4648
Views: 2,480

Bioequivalence [Regulatives / Guidelines]

Difference in proving Bioequivalence in NDA and ANDA.

For ANDA submissions one can show that the generic drug is equivalent to drug which is already exists in Market.

But in NDA with which drug we have to show bioequivalence. And if we can show that our drug (NDA) has more bioavailability than already marketed drug, then can we say that our drug is not equivalent but gives better results that marketed drug.

SriKanth (SriRaj)
Hyderabad.

akl ☆ 2010-01-28 13:21 (5996 d 19:36 ago) (edited on 2010-01-28 13:43) @ Sriraj Posting: # 4654 Views: 1,938	Bioequivalence Post reply
	Bioequivalence is applicable for ANDA and NDA only 505 b2 (not b1). So for NDA 505 b1 clinical trial is required and based on the study Pharmacokinetic data to be reported. Hope above will clarify ur query.. rgds, AKL Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]