Bioequivalence and Bioavailability Forum • Pharmacokinetic interaction study

Pharmacokinetic interaction study [Regulatives / Guidelines]

posted by Mahesh M – India, 2016-05-12 09:07 (3343 d 13:13 ago) – Posting: # 16296
Views: 4,584

Dear All,
My concern regarding Pharmacokinetic interaction study for new combination product, what are the criteria for passing (or how we can say not interact with each other) the Pharmacokinetic interaction study? Is it same as conventional Bioequivalence study criteria (90% CI 80 – 125%).

Please share If any guidance or literature available.

Thanks

Complete thread:

Pharmacokinetic interaction studyMahesh M 2016-05-12 07:07 [Regulatives / Guidelines]
- FDCPs: generally BE (higher BA under certain conditions) Helmut 2016-05-12 13:15
  - FDCPs: generally BE (higher BA under certain conditions) nobody 2016-05-12 13:41
    - FDCPs: generally BE (higher BA under certain conditions) Mauricio Sampaio 2016-05-19 05:47
- Pharmacokinetic interaction study Dr_Dan 2016-05-19 10:05
  - Pharmacokinetic interaction study nobody 2016-05-20 09:40