Jaime_R ★★ Barcelona, 2007-02-23 12:20 (6264 d 07:42 ago) Posting: # 534 Views: 8,080 |
|
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 ★★★ Vienna, Austria, 2007-02-23 14:42 (6264 d 05:20 ago) @ Jaime_R Posting: # 535 Views: 6,597 |
|
Dear Jaime! Funny enough at last year’s Regulatory Workshop on BE/Dissolution I asked Vinod Shah:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
drshiv ★ India, 2007-02-25 16:23 (6262 d 03:39 ago) (edited by HS on 2007-02-25 19:05) @ Jaime_R Posting: # 539 Views: 6,510 |
|
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 ★★ Barcelona, 2007-02-26 12:45 (6261 d 07:17 ago) @ drshiv Posting: # 542 Views: 6,547 |
|
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 the FDA’s Bioavailability / Bioequivalence – General Considerations: Revision 1); Section III.C. @Helmut: Thanks, very entertaining! Edit: Link corrected to latest archived copy. [Helmut] — Regards, Jaime |