PharmPK Discussion - Record of deviation in sampling times

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On 23 Nov 2005 at 05:09:14, ramesh raja (ramesh_7779.aaa.yahoo.co.in) sent the message


Dear sir,
           In BA/BE studies. I started dosing at 8.00am and i given
two minutes gap for each subjects (14 subjects). During sampling how
much minutes i have to take for each subjects. when it will be
deviation. If collection exceeds 30 seconds or  two minutes or three
minutes. If you know please give justification.
Is there any Specific guidelines for sampling deviation.
With regards
Ramesh.N

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On 23 Nov 2005 at 12:30:01, "Cotler, Stanley" (stanley.cotler.-at-.roche.com) sent the message
```
Your record your actual time and do all calculations based on actual
time.
Stanley Cotler
```
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On 23 Nov 2005 at 14:06:03, Ganesh Mugundu (ganaish.-at-.yahoo.com) sent the message


Dear Ramesh,
Guidelines recommend the documentation of "The actual clock time when
samples are collected". If your protocol requires deviation over 30
seconds tol be documented as protocol deviation, then you will have
to comply with your protocol. It depends on what is being stated in
your protocol
For all practical purposes, its wiser to allow atleast 2 minutes
delay from the actual time and anything over that can be documented
as sampling time deviation,  if stated in your protocol.
Hope this helps.
Regards
Ganesh

M.M. Ganesh
PhD Student
College of Pharmacy
University of Cincinnati, Ohio, USA

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