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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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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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The following message was posted to: PharmPK
pl consider atleast 24+ volunteers and WHO guidelines.
Rakesh Chaurasia
Mumbai-India
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