Log in
RegisterNon high fat breakfast [Regulatives / Guidelines]
In many product specific OGDs like Paclitaxel and Liposomal Doxorubicin, it is mentioned that, "If the patient’s health status prevents fasting, the sponsor may provide a non-high-fat diet during the proposed study provided that both study periods are conducted under same conditions."
What is the caloric content and composition of this non-high fat diet?
I am not able to find in USFDA guidelines.
Edit: Please follow the Forum’s Policy. [Helmut]
What is the caloric content and composition of this non-high fat diet?
I am not able to find in USFDA guidelines.
Edit: Please follow the Forum’s Policy. [Helmut]
Complete thread:
- Non high fat breakfastDr Ripal 2016-02-20 09:48 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Non high fat breakfast Dr Ripal 2016-02-23 09:32
- Common sense? Helmut 2016-02-23 13:13
- Non high fat breakfast Dr Ripal 2016-02-23 09:32
Ing. Helmut Schütz