Terminology: Fed study [Regulatives / Guidelines]

posted by Pharma_88 – India, 2021-01-20 11:15 (110 d 20:49 ago) – Posting: # 22184
Views: 414

Dear All,

I came across one condition for the fed study and need your suggestion in this regards.

Question: "Product to be taken at the start of a standard meal". For fed study, dosing will take place 30 min after start of HFHC breakfast. Here terminology as "at the start of standard meal". What to be considered as standard meal? whether its caloric content is 400-500 calories or HFHC (800-100 Calories)? Further, what is the meaning of at the start of standard meal? whether its as per HFHC rule or immediately after meal?

thanks.

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