extrapolated AUC > 20% [Regulatives / Guidelines]
Dear Yuvraj,
About your question, please read... EMA... GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE
this link...
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
They state on the bottom of page 14/27.
Regards,
boonchai
Edit: Link corrected for EMA's new website.
About your question, please read... EMA... GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE
this link...
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
They state on the bottom of page 14/27.
Regards,
boonchai
Edit: Link corrected for EMA's new website.
Complete thread:
- extrapolated AUC > 20% yuvrajkatkar 2010-02-13 14:02
- extrapolated AUC > 20%boonchai_l 2010-02-15 04:17
- extrapolated AUC > 20% yuvrajkatkar 2010-02-15 13:58
- extrapolated AUC > 20% boonchai_l 2010-02-16 05:25
- extrapolated AUC > 20% yuvrajkatkar 2010-02-16 10:28
- extrapolated AUC > 20% boonchai_l 2010-02-16 05:25
- extrapolated AUC > 20% yuvrajkatkar 2010-02-15 13:58
- extrapolated AUC > 20%boonchai_l 2010-02-15 04:17
