Workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation

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Дата: понеделник, 21 November 2016, Цял ден
Местоположение: European Medicines Agency, Amsterdam, the Netherlands

The workshop provides an opportunity to discuss comments received on the draft guideline on PBPK modelling and simulation during public consultation (this consultation is open until 31 January 2017), explain its key messages and provide more details on qualification procedures and evaluation of drug models. It will also aim to communicate EMA's current thinking on the utility of PBPK to stakeholders from other regulatory agencies, the pharmaceutical industry, academia, patient representatives and software developers.

Documents

Programme - EMA workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation

English (EN) (316.04 KB - PDF)

Публикувано за първи път: 07/10/2016 Последна актуализация: 17/11/2016

Registration of interest – EMA workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation (deadline 31 October)

English (EN) (375.33 KB - PDF)

Публикувано за първи път: 07/10/2016 Последна актуализация: 11/10/2016

Presentation - Introduction of the PBPK Guideline and expectations of the day (Anna Nordmark)

English (EN) (752.88 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - CHMP qualification of novel methodologies (Efthymios Manolis)

English (EN) (2.29 MB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Feedback to the draft guideline on qualification and reporting of PBPK modelling and simulation (N. Parrott)

English (EN) (741.31 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Qualification of the PBPK platform for the Intended Purpose: EFPIA comments overview (S. Y. Amy Cheung and Solange Rohou)

English (EN) (1.51 MB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - EMA Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation (Viera Lukacova)

English (EN) (158.96 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Qualification of the Simcyp platform for the intended purposes(Masoud Jamei)

English (EN) (1.47 MB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Qualification of PBPK platform – experience with PK-Sim (Michael Block)

English (EN) (3.07 MB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - PBPK for Paediatric Development (R. Burghaus)

English (EN) (2.59 MB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Reporting and evaluation of predictive performance - what is missing in submissions today? (Sue Cole)

English (EN) (436.23 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Application of physiologically-based pharmacokinetic modeling to support dosing recommendations – The US Food and Drug Administration Experience (Ping Zhao)

English (EN) (910.28 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Sensitivity (Leon Aarons)

English (EN) (520.73 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Uncertainty quantification (Ine Skottheim Rusten)

English (EN) (334.76 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Overview of comments on the guideline received so far and a summary of major areas that require attention (Eva Gil Berglund)

English (EN) (808.28 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Questions to panel on qualification of the PBPK platform for the intended purpose

English (EN) (63.68 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

Presentation - Questions to panel on reporting and evaluation of predictive performance

English (EN) (63.84 KB - PDF)

Публикувано за първи път: 05/12/2016 Последна актуализация: 05/12/2016

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