Log in
Register|
vish14184 ★ India, 2007-06-07 12:52 (6961 d 15:49 ago) Posting: # 784 Views: 6,065 |
|
|
Dear all, If test or reference product administration to the subjects with two min interval (i.e. 8:0, 8:2, 8:4) & subject will continue to remain fasting condition for atleast 04 hr post dose. now, my question are 1. It should be necessary in meal distribution to keep two min interval. for example, sub.no dosing time meal distribution (at least 4 hr after post dose)2. In crossover study if we given meal in Period-I at 12.10, in that case it should be necessary to give meal in second period at same time as period one (12.10) Thanks Regards vishal -- Edit: Category changed. [HS] |
|
gagandeep ● 2007-06-08 09:30 (6960 d 19:11 ago) @ vish14184 Posting: # 788 Views: 4,791 |
|
|
Dear Vishal, You can have two approaches: 1. Give meal at 12:00, 12:02, as you mentioned, but this would be cumbersome. 2. If you look at protocol, it would mention (fasting to continue for AT-LEAST 4 hours). Well it would not be a deviation to give meal to EVERY SUBJECT SIMULTANEOUSLY, for sake of better management and simplicity, after four and half hours instead of 4 hours (at 12:30, provided your dosing has been done before 8:30). In period 2, keep meal again at 12:30. I would definitely go with solution #2 since it will avoid a lot of headache. Regards, Dr. Gagandeep Singh Senior Consultant Domain Consulting Team - Lifesciences Cognizant Technology Solutions |
|
vish14184 ★ India, 2007-06-08 10:37 (6960 d 18:03 ago) @ gagandeep Posting: # 793 Views: 4,687 |
|
|
Thanks sir Reply me i would like to know that if we have keep 2 min interval in dosing (between subject) so its necessary to keep 2 min interval in meal distribution. it should be necessary to give a meal in second period exact same time as period -I.......? Regards vishal Nakrani -- Edit: Full quote removed. Please see this post! [HS] |
|
Dr.Tarak Parikh ☆ India, 2007-06-15 13:47 (6953 d 14:54 ago) @ vish14184 Posting: # 808 Views: 4,752 |
|
|
Dear vishal, i am agree with dr.gagandeep. now here are reasons for that,. 1.To keep uniformity between subjects, so 2 mins intervals are recomended. 2. so timing would be 12.00, 12.02 then goes on... 3. As profile of drugs and absorption of drugs are depend on fasting and fed conditions, so it is very important to maintain similarity within the subjects especially on dosing day, as if it is fasting study then first meal is very important, and in fed study breakfast and first meal is very important.for example food effects are more on ER then IR. thats what i think so if any good ideas then pl. share it. regards Dr.Tarak Parikh MD,Physician Sun Pharmaceuticals Ltd. |
Ing. Helmut Schütz