Log in
Register|
drgopal ☆ India, 2007-09-14 13:54 (6864 d 15:14 ago) Posting: # 1076 Views: 3,381 |
|
|
Dear all, Who should dose the subjects? The Clinical staff will put the tablet/cap into the subjects mouth or will they be given to the subjects for dosing? What is the regulatory requirement? Regards drgopal |
|
usfda_emea ● 2007-10-01 15:20 (6847 d 13:48 ago) @ drgopal Posting: # 1142 Views: 2,489 |
|
|
Dear DrGopal, Both the approaches are observed in various centres involved in these studies. However, the prefered approach is to have the clinical staff administer the dose to the subjects. There are no specific guidelines in any of the agencies websites to the best of my knowledge. The main objective is to ensure proper dosing and compliance to the protocol.  |
Ing. Helmut Schütz