Identification of factors associated with first-cycle drug approval rates and regulatory outcomes for new drug applications-Reference-Cited by-同舟云学术

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Identification of factors associated with first-cycle drug approval rates and regulatory outcomes for new drug applications

Published:2019-01 Issue: Volume:139 Page:166-172
ISSN:1043-6618
Container-title:Pharmacological Research
language:en
Short-container-title:Pharmacological Research

Author:

Chang Lin-Chau^ORCID,Vanheusen Margaret,Fang Xiao,Breder Christopher D.

Publisher

Elsevier BV

Subject

Pharmacology

Reference28 articles.

1. The $2.6 billion pill-methodologic and policy considerations;Avorn;N. Engl. J. Med.,2015

2. The cost of drug development;DiMasi;N. Engl. J. Med.,2015

3. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000–2012;Sacks;JAMA,2014

4. An analysis of the attrition of drug candidates from four major pharmaceutical companies;Waring;Nat. Rev. Drug Discov.,2015

5. Speed, safety, and industry funding - from PDUFA I to PDUFA VI;Darrow;N. Engl. J. Med.,2017

Cited by 3 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. Investigation of Factors Associated With Immunogenicity Labeling Updates and Characteristics of Biologics License Applications;Clinical Pharmacology & Therapeutics;2021-08-24

2. Investigation of quality review issues and the association with application characteristics for new drug applications in first-cycle reviews;Regulatory Toxicology and Pharmacology;2019-11

3. Correlates of time to approval and other clinical development periods;Drug Discovery Today;2019-09

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