Bioequivalence and Bioavailability Forum • Guidance on MR oral and transdermal dosage forms

Guidance on MR oral and transdermal dosage forms [Regulatives / Guidelines]

posted by rohitkachhadiya – Gujarat, 2011-03-21 11:29 (5579 d 02:14 ago) – Posting: # 6782
Views: 4,287

Dear All,

I have a doubt in Guidance on MR oral and transdermal dosage form, Page 11 of 11, i.e for MR formulations essential similar to Marketed one flow chart.

It says that if there is pronounce food effect/no data available then we have to perform both fast and fed study, But if there is no food effect then do fed study only.

Is it not something confusing???

Regards
RK

Complete thread:

Guidance on MR oral and transdermal dosage formsrohitkachhadiya 2011-03-21 10:29
- MR fasting/fed Helmut 2011-03-21 13:34
  - MR fasting/fed rohitkachhadiya 2011-03-23 06:07
    - EU-MR: no food effect ⇒ fed study Helmut 2011-03-23 15:26
      - EU-MR: no food effect ⇒ fed study rohitkachhadiya 2011-03-24 05:27
        
        EU-MR: no food effect ⇒ fed study Helmut 2011-03-24 05:45
        
        DNFTT Jaime_R 2011-03-24 12:36