Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation-Reference-Cited by-同舟云学术

Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation

Published:2016-03 Issue:3 Volume:5 Page:93-122
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

,Marshall SF¹,Burghaus R²,Cosson V³,Cheung SYA⁴,Chenel M⁵,DellaPasqua O⁶,Frey N³,Hamrén B⁷,Harnisch L¹,Ivanow F⁸,Kerbusch T⁹,Lippert J²,Milligan PA¹,Rohou S¹⁰,Staab A¹¹,Steimer JL¹²,Tornøe C¹³,Visser SAG¹⁴

Affiliation:

1. Pharmacometrics; Pfizer Ltd; Sandwich UK

2. Systems Pharmacology & Medicine; Bayer Pharma AG; Wuppertal Germany

3. Clinical Pharmacometrics; F. Hoffmann-La Roche Ltd; Basel Switzerland

4. Quantitative Clinical Pharmacology; AstraZeneca; Cambridge UK

5. Institut de Recherches Internationales; Servier; Suresnes France

6. Clinical Pharmacology Modelling & Simulation; GlaxoSmithKline R&D Ltd; Uxbridge UK

7. Quantitative Clinical Pharmacology; AstraZeneca; Gothenburg Sweden

8. Global regulatory policy & Intelligence; Janssen R&D; High Wycombe UK

9. Quantitative Pharmacology & Pharmacometrics; MSD; Oss Netherlands

10. Global Regulatory Affairs & Policy; AstraZeneca; Paris France

11. Translational Medicine & Clinical Pharmacology; Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach Germany

12. Pharmacometrics; Novartis; Basel CH

13. Clinical Reporting; Novo Nordisk A/S; Søborg Denmark

14. Quantitative Pharmacology & Pharmacometrics; Merck & Co; Kenilworth USA

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Reference104 articles.

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2. The role of modeling and simulation in development and registration of medicinal products: output from the EFPIA/EMA Modeling and Simulation Workshop;Manolis;CPT Pharmacometrics Syst. Pharmacol.,2013

3. Modeling and simulation at the interface of nonclinical and early clinical drug development;Visser;CPT Pharmacometrics Syst Pharmacol.,2013

4. Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims;Marshall;CPT Pharmacometrics Syst. Pharmacol.,2013

5. Modeling and Simulation as a Tool to Bridge Efficacy and Safety Data in Special Populations;Harnisch;CPT: Pharmacometrics & Systems Pharmacology,2013

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