Dr Ripal
☆    

India,
2016-02-20 10:48
(3318 d 19:58 ago)

Posting: # 16014
Views: 3,483
 

 Non 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]
Dr Ripal
☆    

India,
2016-02-23 10:32
(3315 d 20:13 ago)

@ Dr Ripal
Posting: # 16023
Views: 2,532
 

 Non high fat breakfast

No reply from anyone? or there is no answer?
Helmut
★★★
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Homepage
Vienna, Austria,
2016-02-23 14:13
(3315 d 16:32 ago)

@ Dr Ripal
Posting: # 16025
Views: 2,496
 

 Common sense?

Dear Ripal,

❝ No reply from anyone? or there is no answer?


Please follow the Forum’s Policy, especially here and there. Three days  two weeks.
We are posting in our free time. Posts like yours switch some of us into idle mode.

Concerning your question, see my signature first. SCNR.
What do you not understand by the term “non-high-fat diet”? Consult with an oncologist, a dietician, and the PI which diet is suitable for a particular patient.
You will never find everything stated in guidelines. What about common sense?

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