Non high fat breakfast [Regulatives / Guidelines]

posted by Dr Ripal – India, 2016-02-20 10:48 (3780 d 12:05 ago) – Posting: # 16014
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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.


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