Bioequivalence and Bioavailability Forum • Deviating from a guidance

Deviating from a guidance [Design Issues]

posted by Pharma_88 – India, 2024-05-21 10:32 (764 d 10:42 ago) – Posting: # 24005
Views: 6,315

Dear Helmut,

Thank you. Yes for For submission study, will definitely initiate CC with FDA. Since this is a pilot study where main objective is to assess the possibility of the single dose administration effect on pharmacokinetic as well as safety. So any possibility to conduct parallel design study? if yes, how it will be designed?

—
Regards,
Pharma_88

Complete thread:

Single dose PK study on Patients Pharma_88 2024-05-15 05:37
- Single dose PK study on Patients Ohlbe 2024-05-15 09:39
  - Single dose PK study on Patients Pharma_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 guidancePharma_88 2024-05-21 08:32
        
        No, sorry Ohlbe 2024-05-21 12:41