Fingerprint Fingerprint is based on mining the text of the person's scientific documents to create an index of weighted terms, which defines the key subjects of each individual researcher.

Brain Medicine & Life Sciences
Therapeutics Medicine & Life Sciences
Psychotic Disorders Medicine & Life Sciences
Placebos Medicine & Life Sciences
Prostaglandin-Endoperoxide Synthases Medicine & Life Sciences
Central Nervous System Medicine & Life Sciences
Messenger RNA Medicine & Life Sciences
Somatostatin Receptors Medicine & Life Sciences

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Research Output 1984 2018

Exposure– and Dose–response Analyses in Dose Selection and Labeling of FDA-approved Biologics

Ogasawara, K., Breder, C. D., Lin, D. H. & Alexander, G. C. Jan 1 2018 In : Clinical Therapeutics. 40, 1, p. 95-102.e2

Research output: Research - peer-reviewArticle

United States Food and Drug Administration
Biological Products
Pharmaceutical Preparations
Drug Evaluation
Licensure

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications

Chang, L. C., Mahmood, R., Qureshi, S. & Breder, C. D. Jun 1 2017 In : PLoS ONE. 12, 6, e0178104

Research output: Research - peer-reviewArticle

Licensure
Biological Products
Safety
Pharmaceutical Preparations
new drugs

Regulatory watch: The target product profile as a tool for regulatory communication: Advantageous but underused

Tyndall, A., Du, W. & Breder, C. D. Mar 1 2017 In : Nature Reviews Drug Discovery. 16, 3, p. 156 1 p.

Research output: Research - peer-reviewComment/debate

Interdisciplinary Communication
Government Regulation
Drug Approval
Drug Industry
United States Food and Drug Administration

What's the Regulatory Value of a Target Product Profile?

Breder, C. D., Du, W. & Tyndall, A. 2017 (Accepted/In press) In : Trends in Biotechnology.

Research output: Research - peer-reviewArticle

Biological Products
Planning
Pharmaceutical Preparations
Clinical Trials
Databases
Datasets
Software
Research Personnel