Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation-Reference-Cited by-同舟云学术

Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation

Published:2015-04 Issue:4 Volume:4 Page:221-225
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Shepard T¹,Scott G²,Cole S¹,Nordmark A³,Bouzom F⁴

Affiliation:

1. Medicines and Healthcare products Regulatory Agency (MHRA); London UK

2. Takeda Development Centre Europe; London UK

3. Swedish Medical Products Agency (MPA); Uppsala Sweden

4. Technologie Servier; Orleans France

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/psp4.30/fullpdf

Reference8 articles.

1. Shepard , T. Scott , G. Cole , S. Nordmark , A. Bouzom , F. Rowland , M. Zhao , P Meeting report. MISG New Technologies Forum on Physiologically-based Pharmacokinetic (PBPK) Modeling and Simulation http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con457608.pdf

2. Halavan EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/002084/WC500170478.pdf

3. Jakavi EPAR and SmPC http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002464/WC500133226.pdf http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002464/WC500133223.pdf

4. Olysio EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002777/WC500167870.pdf

5. Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and analyses

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