Bioequivalence and Bioavailability Forum • Metadate CD (30/70)

Metadate CD (30/70) [BE/BA News]

posted by Helmut – Vienna, Austria, 2012-03-28 17:45 (5196 d 08:25 ago) – Posting: # 8342
Views: 29,729

Dear John!

❝ Do you think eventually FDA will impose the "biphasic" BE requirement for other methylphendiate MRs as well, like Metadate CD?

Definitely. The guidance deals with ER capsules. Metadate CD contains 30% of the dose as IR beads and 70% as ER beads. BTW, not bioequivalent to Concerta if partial AUC is considered.^*

González MA, Pentikis HS, Anderl N, Benedict MF, DeCory HH, Dirksen SJ, Hatch SJ. Methylphenidate bioavailability from two extended-release formulations. Int J Clin Pharmacol Ther. 2002;40(4):175–8.

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Helmut Schütz

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Science Quotes

Complete thread:

EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
  - EMA: Q&A on biphasic MR products Helmut 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