Bioequivalence and Bioavailability Forum

Clinical Equivalence Studies [Off Topic]

posted by Helmut  – Vienna, Austria, 2007-02-23 14:42 (7067 d 21:12 ago) – Posting: # 535
Views: 9,550

Dear Jaime!

Funny enough at last year’s Regulatory Workshop on BE/Dissolution I asked Vinod Shah:

• Were there any ANDAs approved based on a clinical equivalence study?
  
• If yes, how many subjects were involved?

The answer was:

• No! (within the 30 years Vinod was with the FDA)

Consequently – although mentioned in many guidelines – I would consider clinical equivalence studies a rather hypothetical option.

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


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Complete thread:

• Clinical Equivalence Studies Jaime_R 2007-02-23 11:20 
  • Clinical Equivalence StudiesHelmut 2007-02-23 13:42
  • Clinical Equivalence Studies drshiv 2007-02-25 15:23
    • Clinical Equivalence Studies Jaime_R 2007-02-26 11:45