alinpharma
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2008-07-21 13:25
(6546 d 15:36 ago)

Posting: # 2067
Views: 6,774
 

 BE/BA study and food distribution [Study Per­for­mance]

Dear All!,

Usually In a bioequivalence/bioavailability study food distribution is being carried out at specific timing’s till 04 hours post dose, and then after can the snacks and dinner can be served at approximate timings? Is it necessary to stick on to a particular timings or can we provide it in approximate timings? Dose it have any impact over the study?

Alin J.S. Jinu
Clinical Research Associate
Micro Therapeutic Research Labs Private Limited
No.33, Hasthinapuram Main Road,
Nehru Nagar, Chromepet, Chennai - 44.
Ph : 044 - 22238846, 56, Extn : 13
Web : www.microtheraps.com

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2008-07-21 22:59
(6546 d 06:01 ago)

@ alinpharma
Posting: # 2069
Views: 5,260
 

 BE/BA study and food distribution

Dear Alin!

❝ Usually In a bioequivalence/bioavailability study food distribution is

❝ being carried out at specific timing’s till 04 hours post dose, and

❝ then after can the snacks and dinner can be served at approximate timings?

❝ Is it necessary to stick on to a particular timings or can we provide it

❝ in approximate timings? Dose it have any impact over the study?


Have a look at this thread.
If it's not a study designed to evaluate a food effect I would opt for Gagandeep's method #2 for matters of simplicity. :hungry:

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