Bioequivalence and Bioavailability Forum • Therapeutic Occupancy Time

Therapeutic Occupancy Time [Regulatives / Guidelines]

posted by heritage – India, 2018-02-18 08:19 (1932 d 20:08 ago) – Posting: # 18432
Views: 3,040

Hi Helmut

Thank you for your reply

I need to learn three points

1. What should be design and patient population of the study? I found many studies on clinical trials.gov wherein patient was taken.

Can you advice any good articles to read wherein healthy were taken

2. T>MIC study can waive need to do clinical trial?

3. Is there any regulatory guidance available for T>MIC stud?

Complete thread:

T>MIC for Anti microbial is sufficient to show therapeutic efficacy heritage 2018-02-17 07:32 [Regulatives / Guidelines]
- T>MIC for Anti microbial is sufficient to show therapeutic efficacy ElMaestro 2018-02-17 12:11
  - T>MIC for Anti microbial is sufficient to show therapeutic efficacy heritage 2018-02-17 14:26
    - T>MIC for Anti microbial is sufficient to show therapeutic efficacy ElMaestro 2018-02-17 18:13
    - Therapeutic Occupancy Time Helmut 2018-02-17 21:27
      - Therapeutic Occupancy Timeheritage 2018-02-18 07:19