Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices-Reference-Cited by-同舟云学术

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Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices

Published:2011 Issue: Volume: Page:n/a-n/a
ISSN:1542-9733
Container-title:Birth Defects Research Part B: Developmental and Reproductive Toxicology
language:en
Short-container-title:Birth Defects Research Part B: Developmental and Reproductive Toxicology

Author:

Morford LaRonda L.,Bowman Christopher J.,Blanset Diann L.,Bøgh Ingrid B.,Chellman Gary J.,Halpern Wendy G.,Weinbauer Gerhard F.,Coogan Timothy P.

Publisher

Wiley

Subject

Health, Toxicology and Mutagenesis,Developmental Biology,Toxicology,Embryology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/bdrb.20305/fullpdf

Reference120 articles.

1. Longitudinal reproductive profiles in infants: peak of inhibin B levels in infant boys exceeds levels in adult men;Anderson;J Clin Endocrinol Metab,1998

2. Mechanism-based concepts of size and maturity in pharmacokinetics;Anderson;Annu Rev Pharmacol Toxicol,2008

3. Developing drugs for pediatric use: a role for juvenile studies?;Baldrick;Regul Toxicol Pharmacol,2004

4. Juvenile animal testing in drug development: is it useful?;Baldrick;Regul Toxicol Pharmacol,2010

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1. Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity, Drug Abuse Liability, and Pediatric Safety;International Journal of Toxicology;2024-07-20

2. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies;Pharmaceutics;2023-10-06

3. Juvenile toxicity study of PF ‐07256472/recifercept, a recombinant human soluble fibroblast growth factor receptor 3, in 2–3‐month‐old cynomolgus monkeys;Birth Defects Research;2022-11-11

4. Clearance, biodistribution, and neuromodulatory effects of aluminum-based adjuvants. Systematic review and meta-analysis: what do we learn from animal studies?;Critical Reviews in Toxicology;2022-07-03

5. Discovery and Optimization of Pyrazole Amides as Inhibitors of ELOVL1;Journal of Medicinal Chemistry;2021-11-08

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