Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials-Reference-Cited by-同舟云学术

Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials

Published:2022-12-16 Issue: Volume: Page:1-11
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Sebastien Bernard¹,Cheung S. Y. Amy²,Corriol-Rohou Solange³,Gamalo-Siebers Margaret⁴^ORCID,Jreich Rana¹,Krishna Rajesh⁵,Liu Jing⁶

Affiliation:

1. Data and Data Science, Sanofi, R&D, Chilly-Mazarin, France

2. Integrated Drug Development, Certara USA Inc, Princeton, NJ, USA

3. Regulatory Affairs and Policy, AstraZeneca, Global Regulatory Policy, R&D, Paris, France

4. Global Biometrics & Data Management, Pfizer, Innovative Health, Collegeville, PA, USA

5. Clinical Pharmacology, Certara USA Inc, Princeton, NJ, USA

6. Clinical Pharmacology, Pfizer Inc, Groton, CT, USA

Funder

no funding

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2022.2149772

Reference11 articles.

1. BLA 125370/s-064 and BLA 761043/s-007 Multi-disciplinary Review and Evaluation Benlysta® (belimumab) for Intravenous Infusion in Children 5 to 17 Years of Age with SLE. Food and Drug Administration. URL: download (fda.gov) (Accessed: January 27, 2022).

2. Power prior distributions for regression models

3. Usefulness of Serial N-terminal Pro-B-type Natriuretic Peptide Measurements to Predict Cardiac Death in Acute and Chronic Dilated Cardiomyopathy in Children

4. Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation

5. Bayesian Data Analysis

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1. Pharmacometrics enhanced Bayesian borrowing approach to improve clinical trial efficiency: Case of empagliflozin in type 2 diabetes;CPT: Pharmacometrics & Systems Pharmacology;2023-08-30

2. Pediatric needs should be considered early in the clinical development lifecycle;Journal of Biopharmaceutical Statistics;2023-08-08