Promazine hydrochloride Pharmacokinetics [Design Issues]

posted by pjs – India, 2015-05-14 16:20 (2611 d 02:45 ago) – Posting: # 14819
Views: 8,612

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.


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