PharmPK Discussion - BE guidelines for Sri Lanka

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On 6 Sep 2007 at 09:08:12, "deva krish" (devishabana.at.gmail.com) sent the message


hi everyone,
Do you have any idea about guidelines of conducting BA BE studies for
srilanka.
Are they following WHO guidelines or any other.  How many volunteers
they will recruit for the studies.
Thanks in advance
devisha.

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On 6 Sep 2007 at 10:17:06, "Parinam, Aparna" (aparna.parinam.aaa.ratiopharm.in) sent the message


The following message was posted to: PharmPK

HI Devisha
To my knowledge, there are no specific guidelines for BE studies in
Srilanka.
But WHO guidelines will be acceptable.

Earlier, we had filed BE study data which had 12 volunteers, but now the
requirements may have changed.

With best regards
Aparna

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On 6 Sep 2007 at 13:32:16, "Rakesh Chaurasia" (rakeshchaurasia.-a-.macleodspharma.com) sent the message


The following message was posted to: PharmPK

pl consider atleast 24+ volunteers and WHO guidelines.

Rakesh Chaurasia
Mumbai-India

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