Bioequivalence and Bioavailability Forum • Single dose PK study on Patients

Single dose PK study on Patients [Design Issues]

posted by Pharma_88 – India, 2024-05-17 12:06 (198 d 11:01 ago) – Posting: # 23998
Views: 2,489

Dear Ohlbe,

Thank you for responding. Drug is Olaparib and OGD recommends Two-way crossover Steady State PK study. One of our client wish to conduct single dose BE study as a conventional design without interrupting ongoing treatment of patient. Now whether its a feasible by taking appropriate measures of clinical safety?

Regards,
Pharma_88

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

—
Regards,
Pharma_88

Complete thread:

Single dose PK study on Patients Pharma_88 2024-05-15 05:37 [Design Issues]
- Single dose PK study on Patients Ohlbe 2024-05-15 09:39
  - Single dose PK study on PatientsPharma_88 2024-05-17 10:06
    - No, sorry Ohlbe 2024-05-17 13:45
      - No, sorry Pharma_88 2024-05-20 06:50
        
        Deviating from a guidance Helmut 2024-05-20 07:57
        
        Deviating from a guidance Pharma_88 2024-05-21 08:32
        
        No, sorry Ohlbe 2024-05-21 12:41