Promazine hydrochloride Pharmacokinetics [Design Issues]

posted by pjs – India, 2015-05-14 18:20 (3703 d 03:39 ago) – Posting: # 14819
Views: 11,343

Dear all,

just one qurious question dnt knw about regulatory acceptance.

If the diff dosage form (like sol) than innovator product is approved based on hybrid submission and shown acceptable BE. then can that generic be used as reference product.

note the drug is BCS class 1 drug
the idea behind using innovator as ref is that not more than 20% difference is there for all generic but in this case dosage form is sol so no disso evaluation and diff. bcs class 1 molecule, no excipient diff. no deviation from approved ref product can be thought. also generic is available in RMS and is well tolerated for more than 10 years.

please share your views.

Regards,
Pjs

Complete thread:

UA Flag
Activity
 Admin contact
23,426 posts in 4,929 threads, 1,681 registered users;
45 visitors (0 registered, 45 guests [including 29 identified bots]).
Forum time: 22:00 CEST (Europe/Vienna)

You can do one of two things; just shut up,
which is something I don’t find easy,
or learn an awful lot very fast,
which is what I tried to do.    Jane Fonda

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5