Bioequivalence and Bioavailability Forum • EMA: Q&A on biphasic MR products

EMA: Q&A on biphasic MR products [BE/BA News]

posted by Helmut – Vienna, Austria, 2012-03-07 04:52 (4814 d 01:22 ago) – Posting: # 8223
Views: 23,009

Dear ElMaestro!

❝ I can follow the logic, …

Me too. Like it.

❝ … although I could be a little afraid that the innovator industry as a means of brand protection could start building IP protection around the cut-offs (or other). It would be tremendously effective if granted.

Can be very tough. Early partial AUCs are always highly variable. No scaling for EMA… See this one (slides 51–56). Besides the CV, have a look at the PEs of the two studies of slide 54. All formulations got approval as hybrids (MR vs. IR + clinical studies). Interchangeability: ¡nada!

❝ What's your own take on this?

I make my living from it. :-D

Joking aside I like that some clinical reasoning seems to come back. Or I’m just getting old (1980s-style: steady state to reduce variability, active metabolite if longer half-live than parent, music of the Talking Heads, Laurie Anderson’s performances, etc.).

Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee,
April 13, 2010
Midha KK and G McKay
Use of Partial Area Under the Curve for BE Assessment of Products with Complex PK Profiles; a View Point
slides 1–58
RA Lionberger
PK Profile Comparison for Modified Release Products
slides 59-85
BM Davit
Use of Partial AUC: Case Studies and BE Approaches
slides 86-177

—
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

Complete thread:

EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23 [BE/BA News]
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
  - EMA: Q&A on biphasic MR productsHelmut 2012-03-07 03:52
    - EMA: Q&A on biphasic MR products ElMaestro 2012-03-07 19:20
- EMA vs. FDA d_labes 2012-03-07 10:26
  - MPH examples Helmut 2012-03-07 14:22
    - MPH examples d_labes 2012-03-07 16:18
      - MPH examples Helmut 2012-03-08 01:07
        
        FDA more straight? d_labes 2012-03-08 08:29
        
        and what about power? ElMaestro 2012-03-08 11:37
        
        and what about power? d_labes 2012-03-08 13:26
        and what about power? Helmut 2012-03-08 13:36
        
        FDA more straight? Helmut 2012-03-08 12:51
        
        FDA more straight? luvblooms 2012-03-09 06:55
        
        Multiphasic MR ≠ DR Helmut 2012-03-09 12:18
        
        Multiphasic MR ≠ DR jag009 2012-03-28 15:29
        
        Metadate CD (30/70) Helmut 2012-03-28 15:45