Design [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-08-27 16:07 (673 d 08:30 ago) – Posting: # 21893
Views: 6,636

Dear All,

We are thinking to perform steady state BE study for XXX submission where Test product is ER formulation and Reference product is IR formulation. Further, Its HVD product. So, question is whether is this feasible to conduct replicate BE IR vs ER and if yes then what are the parameters for conclusion?

Thanks.

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