Difference between BABE study and clinical trials [Design Issues]

posted by dshah – India/United Kingdom, 2020-07-31 10:46 (535 d 07:12 ago) – Posting: # 21813
Views: 2,022

Dear VijithRoy!
As rightly mentioned by Helmut, BABE studies are considered as Phase-I study. Generally the concept for generics to perform BABE study is to use the already available knowledge of Innovator for safety and efficacy.
Apart from BCS based biowaiver;
A- Parenteral (IV, IM, SC, IT) adm. as aqueous solution;
B- Solution for oral use,
C-Gas ,
D- Powder for reconstitution as a solution (Meeting above A or B)
E- Otic or ophthalmic or topical product prepared as an aqueous solution
and few other dosage forms can be considered for biowaiver where BE is self evident.
On the other hand, Q1/Q2/Q3 criteria may needs to be matched to Innovator (case to case basis).

Regards,
DShah

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