Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children-Reference-Cited by-同舟云学术

Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children

Published:2016-11-08 Issue:3 Volume:36 Page:426-441
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Hampson Lisa V.¹,Fisch Roland²,Van Linh M.³,Jaki Thomas¹^ORCID

Affiliation:

1. Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics; Lancaster University; Lancaster LA1 4YF U.K.

2. Biostatistical Science and Pharmacometrics; Novartis Pharma AG; Basel CH-4002 Switzerland

3. Biostatistical Science and Pharmacometrics; Novartis Pharmaceutical; Cambridge 02139 MA U.S.A.

Funder

Medical Research Council

Career Development Fellowship

National Institute for Health Research

the National Institute for Health Research or the Department of Health

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference47 articles.

1. European Medicines Agency ICH Topic E11. Clinical investigation of medicinal products in the paediatric population 2001 http://www.ema.europa.eu/docs/ens_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf

2. Food and Drug Administration Guidance for Industry. Exposure-response relationships - study design, data analysis, and regulatory applications 2003 http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm072109.pdf

3. Extrapolation of adult data and other data in pediatric drug-development programs;Dunne;Pediatrics,2011

4. European Medicines Agency Concept paper on extrapolation of efficacy and safety in medicine development http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142358. pdf 2013

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1. Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children;Statistics in Medicine;2016-11-08