Jaime_R
Senior

Barcelona,
2007-02-23 11:20

Posting: # 534
Views: 5,657
 

 Clinical Equivalence Studies [Off Topic]

Dear all,

out of curiosity: has anybody seen a clinical equivalence study (where a bioequivalence study was infeasible due to high CV, low concentrations, etc.)?

Regards, Jaime
Helmut
Hero
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Homepage
Vienna, Austria,
2007-02-23 13:42

@ Jaime_R
Posting: # 535
Views: 4,766
 

 Clinical Equivalence Studies

Dear Jaime!

Funny enough at last year's Regulatory Workshop on BE/Dissolution I asked Vinod Shah :
- are 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 Dr Shah was at the FDA)

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

Cheers,
Helmut Schütz
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drshiv
Regular

India,
2007-02-25 15:23
(edited by HS on 2007-02-25 19:05)

@ Jaime_R
Posting: # 539
Views: 4,666
 

 Clinical Equivalence Studies

Dear Jaime,

Since this is an off topic, I would be bold to add few lines here. Clinical equivalence are those studies in my opinion where there is a need to see pharmacodynamic end points rather than concentrations in blood. Examples are meter-dose inhalers (MDIs). There are canadian and other guidelines how to conduct studies for approval of generic MDIs. Some studies we have conducted on MDIs involved the measurement of FEV1 activity in mild to moderate asthmatic patients. There may be few more expamles on this list.

Dr. Shiv

Edit: Full quote removed. [HS]
Jaime_R
Senior

Barcelona,
2007-02-26 11:45

@ drshiv
Posting: # 542
Views: 4,646
 

 Clinical Equivalence Studies

Dear Dr. Shiv!

» Clinical equivalence are those studies in my opinion where there is a need to see pharmacodynamic end points rather than concentrations in blood.

Sorry, but in my original post I was specifically talking about Clinical Equivalence Studies, not Pharmacodynamic Equivalence Studies (see http://www.fda.gov/cder/guidance/5356fnl.pdf FDA's Bioavailability / Bioequivalence - General Considerations: Revision 1; Section III C - not Section III B).

@Helmut
Thanks, very entertaining! :-D


Edit: Link corrected to latest archived copy. [Helmut]

Regards, Jaime
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