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RegisterBioequivalence 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
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
Complete thread:
- Bioequivalence Between two different formulationsvalivetiananth 2016-10-29 13:07
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- Bioequivalence Between two different formulations Ohlbe 2016-10-31 11:03
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