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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

Drug metabolism and disposition, 2015-04, Vol.43 (4), p.490-509

2015

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Ensuring diversity in clinical trials: The role of clinical pharmacology

Contemporary clinical trials, 2022-07, Vol.118, p.106807-106807, Article 106807

2022

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P-glycoprotein related drug interactions: clinical importance and a consideration of disease states

Expert opinion on drug metabolism & toxicology, 2010-05, Vol.6 (5), p.603-619

2010

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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

Clinical pharmacology and therapeutics, 2022-07, Vol.112 (1), p.90-100

2022

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Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

The AAPS journal, 2008-06, Vol.10 (2), p.373-379

2008

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ITC Commentary on Metformin Clinical Drug–Drug Interaction Study Design That Enables an Efficacy‐ and Safety‐Based Dose Adjustment Decision

Clinical pharmacology and therapeutics, 2018-11, Vol.104 (5), p.781-784

2018

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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

The AAPS journal, 2020-12, Vol.23 (1), p.7-7, Article 7

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

The AAPS journal, 2020-07, Vol.22 (5), p.97-97, Article 97

2020

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A Technique to Estimate In Vivo Dissolution Profiles Without Data from a Solution

The AAPS journal, 2012-09, Vol.14 (3), p.433-436

Cook, Jack A.

2012

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Development strategies for IVIVC in an industrial environment

Biopharmaceutics & drug disposition, 2012-10, Vol.33 (7), p.349-353

Cook, Jack A.

2012

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The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

Journal of pharmaceutical sciences, 2014-11, Vol.103 (11), p.3377-3397

2014

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Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Journal of pharmaceutical sciences, 2016-11, Vol.105 (11), p.3243-3255

2016

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Impact of Biopharmaceutics Classification System-Based Biowaivers

Molecular pharmaceutics, 2010-10, Vol.7 (5), p.1539-1544

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

Molecular pharmaceutics, 2010-04, Vol.7 (2), p.398-411

2010

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Pharmacokinetics of Pregabalin in Subjects with Various Degrees of Renal Function

Journal of clinical pharmacology, 2003-03, Vol.43 (3), p.277-283

2003

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Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

The AAPS journal, 2010-09, Vol.12 (3), p.465-472

2010

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Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

The AAPS journal, 2012-09, Vol.14 (3), p.627-638

2012

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Summary workshop report: Biopharmaceutics classification system—implementation challenges and extension opportunities

Journal of pharmaceutical sciences, 2004-06, Vol.93 (6), p.1375-1381

2004

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Lack of a pharmacokinetic interaction between azithromycin and chloroquine

The American journal of tropical medicine and hygiene, 2006-03, Vol.74 (3), p.407-412

2006

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A Perspective on the Use of Concentration-QT Modeling in Drug Development

Journal of clinical pharmacology, 2008-01, Vol.48 (1), p.9-12

2008

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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

Pharmaceutical research, 2003-11, Vol.20 (11), p.1752-1759

2003

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Investigation of EDTA anticoagulant in plasma to improve the throughput of liquid chromatography/tandem mass spectrometric assays

Rapid communications in mass spectrometry, 2003-01, Vol.17 (10), p.1065-1070

2003

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Refining the In Vitro and In Vivo Critical Parameters for P-Glycoprotein, [I]/IC 50 and [I 2 ]/IC 50 , That Allow for the Exclusion of Drug Candidates from Clinical Digoxin Interaction Studies

Molecular pharmaceutics, 2010-04, Vol.7 (2), p.398-411

2010

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Kinetics, dynamics, and bioavailability of bumetanide in healthy subjects and patients with congestive heart failure

Clinical pharmacology and therapeutics, 1988-11, Vol.44 (5), p.487-500

1988

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An Industrial Implementation of the Biopharmaceutics Classification System

Dissolution technologies, 2002, Vol.9 (2), p.6-8

2002

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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

Ensuring diversity in clinical trials: The role of clinical pharmacology

P-glycoprotein related drug interactions: clinical importance and a consideration of disease states

Exposure‐Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies

Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

ITC Commentary on Metformin Clinical Drug–Drug Interaction Study Design That Enables an Efficacy‐ and Safety‐Based Dose Adjustment Decision

Correction to: Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products

Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products

A Technique to Estimate In Vivo Dissolution Profiles Without Data from a Solution

Development strategies for IVIVC in an industrial environment

The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Impact of Biopharmaceutics Classification System-Based Biowaivers

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

Pharmacokinetics of Pregabalin in Subjects with Various Degrees of Renal Function

Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

Summary workshop report: Biopharmaceutics classification system—implementation challenges and extension opportunities

Lack of a pharmacokinetic interaction between azithromycin and chloroquine

A Perspective on the Use of Concentration-QT Modeling in Drug Development

The use of clinical trial simulation to support dose selection: Application to development of a new treatment for chronic neuropathic pain

Investigation of EDTA anticoagulant in plasma to improve the throughput of liquid chromatography/tandem mass spectrometric assays

Refining the In Vitro and In Vivo Critical Parameters for P-Glycoprotein, [I]/IC 50 and [I 2 ]/IC 50 , That Allow for the Exclusion of Drug Candidates from Clinical Digoxin Interaction Studies

Kinetics, dynamics, and bioavailability of bumetanide in healthy subjects and patients with congestive heart failure

An Industrial Implementation of the Biopharmaceutics Classification System

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