Bioequivalence and Bioavailability Forum • Bioequivalence Between two different formulations

valivetiananth
☆

India,
2016-10-29 15:07
(3530 d 09:26 ago)

Posting: # 16756
Views: 3,904

Bioequivalence Between two different formulations [Regulatives / Guidelines]

Dear All,

The innovator formulation is soft gelatin capsules and we are proposing a hard gelatin capsules of same strength. The pilot study was conducted b/w two dosage forms in a crossover pattern. The study reveals that, the soft gelatin capsule is exhibiting higher concentrations than the hard gelatin capsules but there is no difference in tmax.

Guide me which type of study is required to prove bioequivalence for FDA submission.

Regards
Valiveti

Ohlbe ★★★ France, 2016-10-31 12:03 (3528 d 11:31 ago) @ valivetiananth Posting: # 16759 Views: 3,132	Bioequivalence Between two different formulations Post reply
	Dear Valiveti, ❝ The study reveals that, the soft gelatin capsule is exhibiting higher concentrations than the hard gelatin capsules How much higher ? Only Cmax affected, or also AUC ? ❝ Guide me which type of study is required to prove bioequivalence for FDA submission. Did you check for product-specific recommendations on the FDA website ? — Regards Ohlbe