FDA: crystal ball [Regulatives / Guidelines]
Hi Helmut and other members,
I would like to rescue this post to know if any member of the forum could share their experiences using truncated AUC0-72 for FDA studies.
We recently performed a study using AUC0-72 (very low CVw indeed) and we would like to know what could we expect from FDA. Any experiences?
Many thanks
I would like to rescue this post to know if any member of the forum could share their experiences using truncated AUC0-72 for FDA studies.
We recently performed a study using AUC0-72 (very low CVw indeed) and we would like to know what could we expect from FDA. Any experiences?
Many thanks
Complete thread:
- truncated design Mahesh M 2015-12-29 11:21 [Regulatives / Guidelines]
- FDA: AUC0–72 Helmut 2015-12-29 13:12
- FDA: AUC0–72 Mahesh M 2015-12-29 13:51
- FDA: crystal ball Helmut 2015-12-29 15:43
- FDA: crystal ballAverroes 2016-05-27 00:01
- FDA: crystal ball Helmut 2015-12-29 15:43
- FDA: AUC0–72 Mahesh M 2015-12-29 13:51
- FDA: AUC0–72 Helmut 2015-12-29 13:12