Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology-Reference-Cited by-同舟云学术

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

Published:2019-06-12 Issue:1 Volume:106 Page:174-181
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Hu Meng¹,Babiskin Andrew¹,Wittayanukorn Saranrat¹,Schick Andreas²,Rosenberg Matthew²,Gong Xiajing¹,Kim Myong‐Jin¹,Zhang Lei¹,Lionberger Robert¹,Zhao Liang¹

Affiliation:

1. Office of Research and StandardsOffice of Generic DrugsCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

2. Office of Program and Strategic AnalysisOffice of Strategic ProgramsCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1479

Reference33 articles.

1. Gottlieb S.FDA working to lift barriers to generic drug competition (2017).

2. 98th Congress.Drug Price Competition and Patent Term Restoration Act of 1984 (1984).

3. US Food and Drug Administration (FDA). Abbreviated New Drug Application (ANDA) . Last updated in 2018.

4. US Food and Drug Administration (FDA).Generic drug user fee amendments. Last updated in 2019.

5. IQVIA database.

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