Bioequivalence and Bioavailability Forum • ABEL

ABEL [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-11-19 16:44 (4239 d 02:39 ago) – Posting: # 13884
Views: 16,343

Hi nobody & Angus,

❝ Other range of 90%-111% only for narrow therapeutic index drugs in Europe

AFAIK a generic of Concerta passed a centralised procedure a while ago. EMA accepted ABEL (i.e., widening of the acceptance range) not only for C_max, but also for the (first only?) pAUC. The same is mentioned in the MR-Draft (line 810). Let’s wait for the final version.

I’m pretty sure that most (all?) other MR formulations in the EU were hybrid applications: BA-studies against IR MPH given twice (τ 4 hours) plus one (or more) therapeutic equivalence studies in children. BTW, approved MR formulations are not interchangeable.^1,2

Haessler F, Tracik F, Dietrich H, Stammer H, Klatt J. A pharmacokinetic study of two modified-release methylphenidate formulations under different food conditions in healthy volunteers. Int J Clin Pharmacol Ther. 2008;46(9):466–76. PMID 18793577
Schütz H, Fischer R, Großmann M, Mazur D, Leis HJ, Ammer R. Lack of bioequivalence between two methylphenidate extended modified release formulations in healthy volunteers. Int J Clin Pharmacol Ther. 2009;47(12):761–9. doi 10.5414/CPP47761

PS @nobody: Any particular reason why you linked the draft BE-GL?

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Complete thread:

Draft FDA guidance on Methylphenidate Hydrochloride kumarnaidu 2014-11-10 08:16
- Five PK metrics + S×F interaction Helmut 2014-11-10 13:57
  - Five PK metrics + S×F interaction AngusMcLean 2014-11-11 19:26
    - Phoenix Helmut 2014-11-11 21:05
      - Phoenix AngusMcLean 2014-11-12 19:25
      - Phoenix AngusMcLean 2014-11-21 00:28
  - Five PK metrics + S×F interaction jag009 2014-11-16 03:39
    - Acceptance limit for the upper 95% confidence bound? Helmut 2014-11-17 12:49
      - Acceptance limit for the upper 95% confidence bound? jag009 2014-11-17 17:29
        
        Quoting László Helmut 2014-11-18 03:56
      - Acceptance limit for the upper 95% confidence bound? AngusMcLean 2014-11-19 13:28
  - Five PK metrics + S×F interaction kumarnaidu 2014-12-09 08:36
    - No RSABE Helmut 2014-12-09 13:18
      - No RSABE kumarnaidu 2014-12-09 14:19
        
        No RSABE Helmut 2014-12-09 14:50
- Five PK metrics + S×F interaction drgunasakaran1 2014-11-10 18:29
  - Five PK metrics + S×F interaction jag009 2014-11-11 18:04
  - Five PK metrics + S×F interaction AngusMcLean 2014-11-11 19:22
    - Five PK metrics + S×F interaction jag009 2014-11-11 20:08
      - Tada! jag009 2014-11-13 20:17
        
        Tada! AngusMcLean 2014-11-13 23:06
        
        Tada! nobody 2014-11-19 09:30
        
        Tada! AngusMcLean 2014-11-19 13:42
        
        Tada! nobody 2014-11-19 13:55
        
        ABELHelmut 2014-11-19 15:44
        
        ABEL nobody 2014-11-19 16:05
        
        ABEL Helmut 2014-11-19 16:59
        
        ABEL nobody 2014-11-19 17:10
        
        ABEL Helmut 2014-11-19 17:16
        
        ABEL AngusMcLean 2014-11-19 17:45
        
        Difficult formulations Helmut 2014-11-19 20:15
        
        Difficult formulations nobody 2014-11-19 21:04
        
        Difficult formulations Helmut 2014-11-19 21:49