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RegisterConc at dosing interval [General Statistics]
posted by Helmut 
– Vienna, Austria, 2013-11-26 16:01 (4222 d 17:22 ago) – Posting: # 11973
Views: 15,230
Hi John,
Yes, that’s a nice one! Currently for EMA BE of MR products has to be demonstrated both after SD and in steady state. Paixão et al.* showed that for drugs with linear PK Cτ is predictive of steady state. We will see whether the mighty oracle will accept this approach and drop the requirement of MD studies in the final guideline.
❝ Compare the concentration at 24 hours (or the dosing interval for the product) between the test and reference.
Yes, that’s a nice one! Currently for EMA BE of MR products has to be demonstrated both after SD and in steady state. Paixão et al.* showed that for drugs with linear PK Cτ is predictive of steady state. We will see whether the mighty oracle will accept this approach and drop the requirement of MD studies in the final guideline.
- Paixão P, Gouveia LF, Morais JAG. An alternative single dose parameter to avoid the need for steady-state studies on oral extended-release drug products. Eur J Pharmaceut Biopharmaceut. 2012; 80(2): 410–7. doi:10.1016/j.ejpb.2011.11.001.
In October 2012 the authors received the AAPS’
“Outstanding Manuscript Award in Modeling and Simulation”.
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Helmut Schütz
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Helmut Schütz
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Complete thread:
- Simulation of data to predict Steady state cakhatri 2013-11-24 10:13 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Nonparametric superposition Helmut 2013-11-24 14:30
- Nonparametric superposition jag009 2013-11-24 23:13
- Nonlinear nightmare Helmut 2013-11-25 02:56
- Nonlinear nightmare jag009 2013-11-25 17:43
- Nonlinear nightmare Helmut 2013-11-26 14:32
- Nonlinear nightmare jag009 2013-11-26 16:00
- OT: Vienna Helmut 2013-11-26 16:27
- OT: Vienna jag009 2013-11-26 17:29
- OT: Vienna Helmut 2013-11-27 13:04
- OT: Vienna jag009 2013-11-26 17:29
- OT: Vienna Helmut 2013-11-26 16:27
- Nonlinear nightmare jag009 2013-11-26 16:00
- Nonlinear nightmare Helmut 2013-11-26 14:32
- Nonlinear nightmare jag009 2013-11-25 17:43
- Nonlinear nightmare Helmut 2013-11-25 02:56
- Conc at dosing interval jag009 2013-11-25 17:48
- Conc at dosing intervalHelmut 2013-11-26 15:01
- Conc at dosing interval jag009 2013-11-26 17:31
- Conc at dosing interval Helmut 2013-11-27 13:10
- Conc at dosing interval jag009 2013-11-27 20:00
- Passing SD and Failing MD luvblooms 2013-11-28 09:19
- Passing SD and Failing MD Helmut 2013-11-29 17:29
- Passing SD and Failing MD luvblooms 2013-11-29 18:57
- Cτ predictive of Cmin Helmut 2013-11-30 17:25
- Passing SD and Failing MD luvblooms 2013-11-29 18:57
- Passing SD and Failing MD Helmut 2013-11-29 17:29
- Conc at dosing interval Helmut 2013-11-27 13:10
- Conc at dosing interval jag009 2013-11-26 17:31
- Conc at dosing intervalHelmut 2013-11-26 15:01
- Nonparametric superposition jag009 2013-11-24 23:13
- Nonparametric superposition Helmut 2013-11-24 14:30
Ing. Helmut Schütz