Model‐Based Assessment of Alternative Study Designs in Pediatric Trials. Part I: Frequentist Approaches-Reference-Cited by-同舟云学术

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Model‐Based Assessment of Alternative Study Designs in Pediatric Trials. Part I: Frequentist Approaches

Published:2016-06 Issue:6 Volume:5 Page:305-312
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Smania G¹²,Baiardi P³,Ceci A¹,Magni P²,Cella M¹⁴

Affiliation:

1. Consorzio per Valutazioni Biologiche e FarmacologichePavia Italy

2. Dipartimento di Ingegneria Industriale e dell'InformazioneUniversità degli Studi di PaviaPavia Italy

3. Direzione Scientifica Centrale, Fondazione Salvatore Maugeri, IRCCSPavia Italy

4. Department of Clinical PharmacologyGlobal Clinical Development, Chiesi FarmaceuticiParma Italy

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12083

Reference42 articles.

1. EU. Regulation on medicinal products for paediatric use. Official Journal of the European Union (2006).

2. FDA. Best Pharmaceuticals for Children Act (2002).

3. FDA. Pediatric Research Equity Act (2003).

4. Pediatric Drug-Trial Recruitment: Enticement Without Coercion

5. Pediatric cardiovascular safety: Challenges in drug and device development and clinical application

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1. Ethical Evaluations of Clinical Trials in France: Towards European Standardization;Philosophy and Medicine;2023

2. Conditional distribution modeling as an alternative method for covariates simulation: Comparison with joint multivariate normal and bootstrap techniques;CPT: Pharmacometrics & Systems Pharmacology;2021-04

3. Conditional distribution modeling as an alternative method for covariates simulation: comparison with joint multivariate normal and bootstrap techniques;2020-11-02

4. Useful pharmacodynamic endpoints in children: selection, measurement, and next steps;Pediatric Research;2018-04-18

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