Publications by authors named "Jack A Cook"

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Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies.
Arnab Mukherjee, Shinichi Tsuchiwata, Timothy Nicholas, Jack A Cook, Irene Modesto

Clin Pharmacol Ther· July 2022

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Ensuring diversity in clinical trials: The role of clinical pharmacology.
Joanna C Masters, Jack A Cook, Ginger Anderson, Gianluca Nucci, Anna Colzi

Contemp Clin Trials· July 2022

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Correction to: Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.
Arzu Selen, Anette Müllertz, Filippos Kesisoglou, Rodney J Y Ho, Jack A Cook

AAPS J· December 2020

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Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.
Arzu Selen, Anette Müllertz, Filippos Kesisoglou, Rodney J Y Ho, Jack A Cook

AAPS J· July 2020

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ITC Commentary on Metformin Clinical Drug-Drug Interaction Study Design That Enables an Efficacy- and Safety-Based Dose Adjustment Decision.
Maciej J Zamek-Gliszczynski, Xiaoyan Chu, Jack A Cook, Joseph M Custodio, Aleksandra Galetin

Clin Pharmacol Ther· November 2018

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Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid.
Paul A Dickinson, Filippos Kesisoglou, Talia Flanagan, Marilyn N Martinez, Hitesh B Mistry, Jack A Cook

J Pharm Sci· November 2016

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Breast cancer resistance protein (ABCG2) in clinical pharmacokinetics and drug interactions: practical recommendations for clinical victim and perpetrator drug-drug interaction study design.
Caroline A Lee, Meeghan A O'Connor, Tasha K Ritchie, Aleksandra Galetin, Jack A Cook

Drug Metab Dispos· April 2015

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The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.
Arzu Selen, Paul A Dickinson, Anette Müllertz, John R Crison, Hitesh B Mistry, Jack A Cook

J Pharm Sci· November 2014

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Development strategies for IVIVC in an industrial environment.
Jack A Cook

Biopharm Drug Dispos· October 2012

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A technique to estimate in vivo dissolution profiles without data from a solution.
Jack A Cook

AAPS J· September 2012

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Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.
James E Polli, Jack A Cook, Barbara M Davit, Paul A Dickinson, Domenick Argenti

AAPS J· September 2012

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Impact of Biopharmaceutics Classification System-based biowaivers.
Jack A Cook, Barbara M Davit, James E Polli

Mol Pharm· October 2010

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Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit.
Arzu Selen, Maria T Cruañes, Anette Müllertz, Paul A Dickinson, Jack A Cook

AAPS J· September 2010

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P-glycoprotein related drug interactions: clinical importance and a consideration of disease states.
Caroline A Lee, Jack A Cook, Eric L Reyner, Dennis A Smith

Expert Opin Drug Metab Toxicol· May 2010

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Refining the in vitro and in vivo critical parameters for P-glycoprotein, [I]/IC50 and [I2]/IC50, that allow for the exclusion of drug candidates from clinical digoxin interaction studies.
Jack A Cook, Bo Feng, Katherine S Fenner, Sarah Kempshall, Ray Liu

Mol Pharm· April 2010

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Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.
James E Polli, Bertil S I Abrahamsson, Lawrence X Yu, Gordon L Amidon, John M Baldoni, Jack A Cook

AAPS J· June 2008

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A perspective on the use of concentration-QT modeling in drug development.
Tanya Russell, Steven P Riley, Jack A Cook, Richard L Lalonde

J Clin Pharmacol· January 2008

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Lack of a pharmacokinetic interaction between azithromycin and chloroquine.
Jack A Cook, Edward J Randinitis, Candace R Bramson, David L Wesche

Am J Trop Med Hyg· March 2006

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Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities.
James E Polli, Lawrence X Yu, Jack A Cook, Gordon L Amidon, Ronald T Borchardt

J Pharm Sci· June 2004

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The use of clinical trial simulation to support dose selection: application to development of a new treatment for chronic neuropathic pain.
Peter A Lockwood, Jack A Cook, Wayne E Ewy, Jaap W Mandema

Pharm Res· November 2003

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Investigation of EDTA anticoagulant in plasma to improve the throughput of liquid chromatography/tandem mass spectrometric assays.
Nalini P Sadagopan, Wenlin Li, Jack A Cook, Betsy Galvan, David L Weller

Rapid Commun Mass Spectrom· May 2003

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Pharmacokinetics of pregabalin in subjects with various degrees of renal function.
Edward J Randinitis, Edward L Posvar, Christine W Alvey, Allen J Sedman, Jack A Cook

J Clin Pharmacol· March 2003

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