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Design [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-08-27 18:07 (1507 d 11:18 ago) – Posting: # 21893
Views: 8,030

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.

—
Regards,
Pharma_88

Complete thread:

DesignPharma_88 2020-08-27 16:07 [Regulatives / Guidelines]
- Jurisdiction? Helmut 2020-08-27 17:32
  - Jurisdiction? Pharma_88 2020-08-31 10:26
    - EMA: ABEL for HVD(P)s, PK metrics Helmut 2020-08-31 12:21
      - EMA: ABEL for HVD(P)s, PK metrics Pharma_88 2020-09-08 09:05
        
        EMA: MD PK metrics Helmut 2020-09-08 17:25

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