An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)-Reference-Cited by-同舟云学术

An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)

Published:2020-07 Issue: Volume:114 Page:104662
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Avila Amy M.,Bebenek Ilona,Bonzo Jessica A.,Bourcier Todd,Davis Bruno Karen L.,Carlson David B.,Dubinion John,Elayan Ikram,Harrouk Wafa,Lee Shwu-Luan,Mendrick Donna L.,Merrill Jill C.,Peretz Jackye,Place Emily,Saulnier Muriel,Wange Ronald L.,Yao Jia,Zhao Dong,Brown Paul C.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference96 articles.

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2. 21CFR314, Code of Federal Regulations. Title 21: Food and Drugs, Subchapter D: Drugs for Human Use, Part 314: Applications for FDA Approval to Market a New Drug.

3. 21CFR601, Code of Federal Regulations. Title 21: Food and Drugs, Subchapter F: Biologics, Part 601: Licensing.

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5. Gastrointestinal safety pharmacology in drug discovery and development;Al-Saffar;Handb. Exp. Pharmacol.,2015

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