Bioequivalence and Bioavailability Forum

Food during run-in period [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2008-05-06 18:23 (6628 d 22:17 ago) – Posting: # 1823
Views: 2,457

Dear Shankar!

❝ Our one of the Sponsors has asked us to enroll the volunteers into the CPU

❝ two days prior to dosing to standardize the intake of food for

❝ Antiretroviral drug (Didanosine).

If he/she gets happy with that...

❝ Whether for other food effect studies (fed studies) standardization is

❝ required?

For some endogenous compounds (e.g., potassium) it makes sense; for didanosine I don't get the point...

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Standardization of intake of food in BE studies shankar 2008-05-06 11:35 
  • Food during run-in periodHelmut 2008-05-06 16:23