Log in
RegisterBE Design [Design Issues]
Hi,
If the product's BE guideline is not available in such cases can we design the protocol based on general guideline on BA/BE?
Still do we need to make control correspondence with USFDA with BE study design and get approval before to proceed BE study?
If the product's BE guideline is not available in such cases can we design the protocol based on general guideline on BA/BE?
Still do we need to make control correspondence with USFDA with BE study design and get approval before to proceed BE study?
—
Mahesh N. Padamwar (Ph.D.)
Mahesh N. Padamwar (Ph.D.)
Complete thread:
- BE DesignMahesh 2014-09-25 09:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE Design ElMaestro 2014-09-25 09:57
- CC for “creative” designs Helmut 2014-09-25 13:19
- BE Design ElMaestro 2014-09-25 09:57
Ing. Helmut Schütz