Log in
RegisterBE Design [Design Issues]
Hello Mahesh,
If there is no product-specific recommendation (that's what you mean isn't it?) then you should rely on the general BE guideline but of course it is a good idea to apply a minimum amount of independent thinking; is the product plain and simple or are you dealing with a nightmare like an inhalation product etc?
No, controlled correspondence with FDA is a general option and not a requirement unless otherwise explicitly required by the FDA.
❝ If the product's BE guideline is not available in such cases can we design the protocol based on general guideline on BA/BE?
If there is no product-specific recommendation (that's what you mean isn't it?) then you should rely on the general BE guideline but of course it is a good idea to apply a minimum amount of independent thinking; is the product plain and simple or are you dealing with a nightmare like an inhalation product etc?
❝ Still do we need to make control correspondence with USFDA with BE study design and get approval before to proceed BE study?
No, controlled correspondence with FDA is a general option and not a requirement unless otherwise explicitly required by the FDA.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- BE Design Mahesh 2014-09-25 09:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE DesignElMaestro 2014-09-25 09:57
- CC for “creative” designs Helmut 2014-09-25 13:19
- BE DesignElMaestro 2014-09-25 09:57
Ing. Helmut Schütz