Publications by authors named "Christopher Breder"

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The value proposition in clinical trials: a framework for drug development.
Christopher D Breder

Drug Discov Today· December 2025

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Investigation of Factors Associated With Immunogenicity Labeling Updates and Characteristics of Biologics License Applications.
Ai-Lei Jiang, Christopher D Breder, Lin-Chau Chang

Clin Pharmacol Ther· November 2021

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A Multifaceted Perspective of Pharmaceutical Innovation: A Consideration of the Regulatory Role.
Mark Robberson, Christopher D Breder

Ther Innov Regul Sci· March 2021

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Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016.
G Caleb Alexander, Ken Ogasawara, Dana Wiegand, Dora Lin, Christopher D Breder

Ther Innov Regul Sci· November 2019

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Correlates of time to approval and other clinical development periods.
Christopher D Breder, Margaret VanHeusen, Lin-Chau Chang

Drug Discov Today· September 2019

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Identification of factors associated with first-cycle drug approval rates and regulatory outcomes for new drug applications.
Lin-Chau Chang, Margaret Vanheusen, Xiao Fang, Christopher D Breder

Pharmacol Res· January 2019

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A Critical Evaluation of Safety Signal Analysis Using Algorithmic Standardised MedDRA Queries.
Carolyn Tieu, Christopher D Breder

Drug Saf· December 2018

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Informative graphing of continuous safety variables relative to normal reference limits.
Christopher D Breder

BMC Med Res Methodol· May 2018

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Exposure- and Dose-response Analyses in Dose Selection and Labeling of FDA-approved Biologics.
Ken Ogasawara, Christopher D Breder, Dora H Lin, G Caleb Alexander

Clin Ther· January 2018

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Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.
Lin-Chau Chang, Riaz Mahmood, Samina Qureshi, Christopher D Breder

PLoS One· September 2017

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What's the Regulatory Value of a Target Product Profile?
Christopher D Breder, Wenny Du, Adria Tyndall

Trends Biotechnol· July 2017

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Regulatory watch: The target product profile as a tool for regulatory communication: advantageous but underused.
Adria Tyndall, Wenny Du, Christopher D Breder

Nat Rev Drug Discov· March 2017

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A Method for Retrieval of Adverse Event Terms in Clinical Trial Databases Using Standardised MedDRA Queries.
Christopher D Breder

Pharmaceut Med· April 2016

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A randomized, double-blind, placebo-controlled study of aripiprazole for the treatment of psychosis in nursing home patients with Alzheimer disease.
Joel E Streim, Anton P Porsteinsson, Christopher D Breder, René Swanink, Ronald Marcus

Am J Geriatr Psychiatry· July 2008

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A multicenter, randomized, double-blind study of the effects of aripiprazole in overweight subjects with schizophrenia or schizoaffective disorder switched from olanzapine.
John W Newcomer, Joao Alberto Campos, Ronald N Marcus, Christopher Breder, Robert M Berman

J Clin Psychiatry· July 2008

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A randomized, multicenter, double-blind, placebo-controlled study of the efficacy and safety of aripiprazole for the treatment of alcohol dependence.
Raymond F Anton, Henry Kranzler, Christopher Breder, Ronald N Marcus, William H Carson

J Clin Psychopharmacol· February 2008

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Aripiprazole for the treatment of psychoses in institutionalized patients with Alzheimer dementia: a multicenter, randomized, double-blind, placebo-controlled assessment of three fixed doses.
Jacobo E Mintzer, Larry E Tune, Christopher D Breder, René Swanink, Ronald N Marcus

Am J Geriatr Psychiatry· November 2007

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Aripiprazole for the treatment of psychosis in patients with Alzheimer's disease: a randomized, placebo-controlled study.
Peter De Deyn, Dilip V Jeste, Rene Swanink, Dusan Kostic, Christopher Breder

J Clin Psychopharmacol· October 2005

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