Human radiolabeled mass balance studies supporting the <scp>FDA</scp> approval of new drugs-Reference-Cited by-同舟云学术

Human radiolabeled mass balance studies supporting the FDA approval of new drugs

Published:2022-09-23 Issue:11 Volume:15 Page:2567-2575
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical Translational Sci

Author:

Ramamoorthy Anuradha¹,Bende Girish¹,Chow Edwin Chiu Yuen¹,Dimova Hristina¹,Hartman Neil¹,Jean Daphney¹,Pahwa Sonia¹,Ren Yunzhao¹,Shukla Chinmay¹,Yang Yuching¹,Doddapaneni Suresh¹,Danielsen Zhixia Yan¹

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Silver Spring Maryland USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.13403

Reference28 articles.

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2. Food and Drug Administration. Guidance for Industry.M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.2010.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/m3r2‐nonclinical‐safety‐studies‐conduct‐human‐clinical‐trials‐and‐marketing‐authorization. Accessed December 2021.

3. Mass Balance Studies, with a Focus on Anticancer Drugs

4. The Importance of the Human Mass Balance Study in Regulatory Submissions

5. Regulatory aspects of human radiolabeled mass balance studies in oncology: concise review

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