Bioequivalence and Bioavailability Forum • AUC72

AUC72 [Design Issues]

posted by jag009 – NJ, 2012-05-10 17:15 (5144 d 23:54 ago) – Posting: # 8554
Views: 5,581

Thanks everyone,

One question regarding the truncated AUC 0-72 hrs. Is it applicable only for generic filing or it also applies to supplemental NDA filing? ie, changing from a Tablet to a Capsule (same strength, same indication), from capsule to a tablet, dosage strength proportionality studies?

John

Complete thread:

Parallel study as pilot for long half life drug jag009 2012-05-07 15:13 [Design Issues]
- Parallel study as pilot for long half life drug Dr_Dan 2012-05-07 16:00
  - Parallel study as pilot for long half life drug d_labes 2012-05-07 16:24
  - Parallel study as pilot for long half life drug jag009 2012-05-07 18:15
    - AUC72 Helmut 2012-05-07 19:31
      - AUC72 jag009 2012-05-07 20:15
        
        AUC72 Dr_Dan 2012-05-08 12:17
        
        AUC72jag009 2012-05-10 15:15
        
        AUC72: NDAs Helmut 2012-05-10 15:56
        
        AUC72: NDAs jag009 2012-05-14 15:22