Publications by authors named "Carl Peck"

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Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One‑Sided t‑Tests (TOST).
Jing Wang, Gregory Campbell, Jae H Lee, Meng Hu, Kairui Feng, Carl C Peck

AAPS J· February 2025

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Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022.
Xiaofang Zhang, Carl C Peck, Yaning Wang, Thomas D Szucs, Wan Sun

BMC Med· December 2024

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The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.
Lanyan Fang, Yuqing Gong, Andrew C Hooker, Viera Lukacova, Amin Rostami-Hodjegan, Carl Peck

AAPS J· February 2024

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Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies.
Carl Peck, Gregory Campbell, Isaac Yoo, Kairui Feng, Meng Hu

AAPS J· September 2022

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Probability of Success: A Crucial Concept to Inform Decision Making in Pharmaceutical Research and Development.
Richard L Lalonde, Carl C Peck

Clin Pharmacol Ther· May 2022

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Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929-2020).
Robert J Temple, Robert T O'Neill, Carl C Peck

Clin Pharmacol Ther· June 2021

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Sir Alasdair Breckenridge 1937-2019. A Celebratory Tribute.
Carl C Peck, Ross A Breckenridge

Clin Pharmacol Ther· July 2020

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Scientific considerations for global drug development.
Jennifer L Wilson, Kit Wun Kathy Cheung, Lawrence Lin, Elizabeth A E Green, Analia I Porrás, Carl C Peck

Sci Transl Med· July 2020

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Author Correction: At the end of the beginning: immunotherapies as living drugs.
Ellen G Feigal, Natalie D DeWitt, Cathy Cantilena, Carl Peck, David Stroncek

Nat Immunol· October 2019

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Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation.
Alasdair M Breckenridge, Ross A Breckenridge, Carl C Peck

Br J Clin Pharmacol· September 2019

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At the end of the beginning: immunotherapies as living drugs.
Ellen G Feigal, Natalie D DeWitt, Cathy Cantilena, Carl Peck, David Stroncek

Nat Immunol· August 2019

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Bayesian Approach to Establish Bioequivalence: Why and How?
Carl C Peck, Gregory Campbell

Clin Pharmacol Ther· February 2019

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Farewell to Our Good Friend, Outstanding Mentor, and Colleague Darrell R. Abernethy (1949-2017).
Janice B Schwartz, Raymond L Woosley, Carl C Peck

Clin Pharmacol Ther· April 2018

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Individualized treatment strategies for hyperuricemia informed by a semi-mechanistic exposure-response model of uric acid dynamics.
Sergey Aksenov, Carl C Peck, Ulf G Eriksson, Donald R Stanski

Physiol Rep· March 2018

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Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013.
Hoon Young Suh, Carl C Peck, Kyung-Sang Yu, Howard Lee

Drug Des Devel Ther· April 2017

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Poor medication adherence in clinical trials: consequences and solutions.
Alasdair Breckenridge, Jeffrey K Aronson, Terrence F Blaschke, Dan Hartman, Carl C Peck

Nat Rev Drug Discov· March 2017

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Farewell to our Good Friend and Outstanding Colleague David Flockhart (1952-2015).
Carl C Peck, Raymond L Woosley

Clin Pharmacol Ther· February 2016

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17α-Ethynylestradiol-3-sulfate treatment of severe blood loss in rats.
William Hubbard, James Keith, Jonathan Berman, Matthew Miller, Charles Scott, Carl Peck

J Surg Res· January 2015

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Efficacy of 17α-ethynylestradiol-3-sulfate for severe hemorrhage in minipigs in the absence of fluid resuscitation.
Matthew Miller, James Keith, Jonathan Berman, D Bruce Burlington, Charles Grudzinskas, Carl Peck

J Trauma Acute Care Surg· June 2014

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Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years.
Malcolm Rowland, Christian R Noe, Dennis A Smith, G T Tucker, Daan J A Crommelin, Carl C Peck

J Pharm Sci· November 2012

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Physiologically-based pharmacokinetics in drug development and regulatory science.
Malcolm Rowland, Carl Peck, Geoffrey Tucker

Annu Rev Pharmacol Toxicol· April 2011

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Quantitative clinical pharmacology is transforming drug regulation.
Carl C Peck

J Pharmacokinet Pharmacodyn· December 2010

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A roadmap for biomarker qualification.
David G Warnock, Carl C Peck

Nat Biotechnol· May 2010

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Recommended changes to oncology clinical trial design: revolution or evolution?
Mark J Ratain, Rachel W Humphrey, Gary B Gordon, Gwen Fyfe, Peter C Adamson, Carl C Peck

Eur J Cancer· January 2008

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Current issues relating to drug safety especially with regard to the use of biomarkers: a meeting report and progress update.
Paul Rolan, Meindert Danhof, Donald Stanski, Carl Peck

Eur J Pharm Sci· February 2007

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