Therapeutic Occupancy Time [Regulatives / Guidelines]

posted by heritage – India, 2018-02-18 08:19 (2313 d 03:25 ago) – Posting: # 18432
Views: 3,459

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 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:

UA Flag
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
147 visitors (0 registered, 147 guests [including 6 identified bots]).
Forum time: 12:44 CEST (Europe/Vienna)

Even though it’s applied science we’re
dealin’ with, it still is – science!    Leslie Z. Benet

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz