Bioequivalence and Bioavailability Forum • Variability (MR vs. IR)

Variability (MR vs. IR) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-09-12 17:23 (4664 d 10:25 ago) – Posting: # 11485
Views: 18,632

Dear all,

one goody slipped trough my attention, namely lines 340–344:

The inter-individual variability of the pharmacokinetic parameters of interest should be determined in the single dose or multiple dose studies […] and should be compared between the modified and immediate release formulation. The variability of the modified release formulation should preferably not exceed that of the immediate release formulation.

OK, but how to do that? I guess one-sided (non-superiority) of inter-subject variance is meant. But the inter-subject variance is only accessible in a crossover or a paired design: If we have a SD and a MD study we can only assess the total (pooled) variance.

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Helmut Schütz

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Complete thread:

Draft EMA MR formulations GL published! Ohlbe 2013-03-15 12:10 [Regulatives / Guidelines]
- Housekeeping suggestions Helmut 2013-03-15 13:28
- Scaling for pAUCs Helmut 2013-03-15 14:19
- Draft EMA MR formulations GL published! ioanam 2013-03-30 17:54
  - Topicals → 1995 NfG Helmut 2013-03-30 22:51
  - Topicals, generic ElMaestro 2013-03-31 19:26
    - Topicals, generic ioanam 2013-04-01 07:51
      - Topicals, generic The Outlaw Torn 2013-04-01 08:03
- Clarity on waiving multiple dose study Tina 2013-05-15 14:19
  - Hey, it is just a draft! Helmut 2013-05-17 18:49
    - Critical review of García-Arieta et al. (2012) Helmut 2013-06-29 19:44
- SD vs. MD, partial AUCs Helmut 2013-06-21 19:24
  - SD vs. MD, partial AUCs Shuanghe 2013-06-25 17:22
    - SD vs. MD, partial AUCs Helmut 2013-06-25 19:15
      - SD vs. MD, partial AUCs Shuanghe 2013-06-27 11:07
        
        pAUCs, alternative metrics, alcohol Helmut 2013-06-27 14:38
- tmax (DR & multiphasic) Helmut 2013-06-22 01:15
- Presentations of the EUFEPS meeting Helmut 2013-07-15 15:50
- ⧫ Deadline approaching ⧫ Helmut 2013-08-16 16:41
  - Download comment form Helmut 2013-08-26 11:28
- Food effect Compliance 2013-08-26 12:04
  - Food effect Dr_Dan 2013-08-26 16:48
- Variability (MR vs. IR)Helmut 2013-09-12 15:23