Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation-Reference-Cited by-同舟云学术

Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation

Published:2018-01-31 Issue:3 Volume:103 Page:419-433
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Barrett Jeffrey S.¹,Bishai Raafat²,Bucci-Rechtweg Christina³,Cheung Amy⁴,Corriol-Rohou Solange⁵,Haertter Sebastian⁶,James Angela⁷,Kovacs Steven J.⁸,Liu Jing⁹,Potempa Dennis¹⁰,Strougo Ashley¹⁰,Vanevski Konstantina¹¹,

Affiliation:

1. Translational Medicine, Translational Informatics, Sanofi; Bridgewater New Jersey USA

2. Clinical Development, Metabolic Disease Department; AstraZeneca; Gaithersburg Maryland USA

3. Global Health Policy, Regulatory Affairs, Novartis Pharmaceuticals Corporation; East Hanover New Jersey USA

4. Quantitative Clinical Pharmacology, Early Clinical Development, Innovative Medicines and Early Development Biotech Unit; AstraZeneca Cambridge UK

5. GRAPSQA/Global Medicines Development; Astra Zeneca Paris France

6. Translational Med & Clinical Pharmacology, Boehringer-Ingelheim Pharma; Ridgefield Connecticut USA

7. Clinical Pharmacology and Exploratory Department; Astellas Pharma; Northbrook Illinois USA

8. Translational Medicine, Novartis Institutes for BioMedical Research; East Hanover New Jersey USA

9. Clinical Pharmacology, Pfizer; Groton Connecticut USA

10. Translational Medicine, Pharmacokinetics, Dynamics and Metabolism, M&S; Sanofi Frankfurt Germany

11. Global Clinical Development, Bayer HealthCare; Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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5. International Conference on Harmonization E11 (R1) http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/E11-R1EWG_Step4_Addendum_2017_0818.pdf 2017

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