Renal Impairment in Pediatric Patients: Current Approaches to Drug Dosing

Author:

Khurana Mona1

Affiliation:

1. Division of Pediatrics and Maternal Health Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference30 articles.

1. USFood and Drug Administration. Guidance for industry: exposure‐response relationships—study design data analysis and regulatory applications.https://www.fda.gov/media/71277/download. Published 2003. Accessed May 7 2021.

2. US Food and Drug Administration. Guidance for industry: E11(R1) addendum: clinical investigation of medicinal products in the pediatric population.https://www.fda.gov/media/101398/download. Published 2018. Accessed May 7 2021.

3. Applying the non‐inferiority paradigm to assess exposure‐response similarity and dose between pediatric and adult patients;Zhang Q;J Clin Pharmacol,2021

4. US Food and Drug Administration: Guidance for industry: general clinical pharmacology considerations for pediatric studies for drugs and biological products.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacology-considerations-pediatric-studies-drugs-and-biological-products. Accessed on January 27 2021.

5. Dosing recommendations for pediatric patients with renal impairment;Al‐Khouja A;J Clin Pharmacol,2020

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Drug Dosing in Pediatrics: Possible Approaches;Current Pediatrics;2023-08-25

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