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Clinical Pharmacokinetics and Pharmacodynamics of Dapagliflozin, a Selective Inhibitor of Sodium-Glucose Co-transporter Type 2

Clinical pharmacokinetics, 2014-01, Vol.53 (1), p.17-27

2014

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Reverse Translation: The Art of Cyclical Learning

Clinical pharmacology and therapeutics, 2018-02, Vol.103 (2), p.152-159

2018

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Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study

Diabetes care, 2015-03, Vol.38 (3), p.412-419

2015

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Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor

Clinical pharmacokinetics, 2018-07, Vol.57 (7), p.769-779

2018

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Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy

Clinical and translational science, 2022-08, Vol.15 (8), p.1818-1837

2022

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Pharmacokinetic and Pharmacodynamic Properties of Single- and Multiple-Dose of Dapagliflozin, a Selective Inhibitor of SGLT2, in Healthy Chinese Subjects

Clinical therapeutics, 2013-08, Vol.35 (8), p.1211-1222.e2

2013

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801 Risk-benefit ratio in immunotherapy (IO) with or without chemotherapy (CT) according to PD-L1 expression: a model-based approach to inform treatment decisions in metastatic non-small cell lung cancer

Journal for immunotherapy of cancer, 2023-11, Vol.11 (Suppl 1), p.A901-A901

2023

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Influence of Hepatic Impairment on the Pharmacokinetics and Safety Profile of Dapagliflozin: An Open-Label, Parallel-Group, Single-Dose Study

Clinical therapeutics, 2011-11, Vol.33 (11), p.1798-1808

2011

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Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: A randomized, open-label, multiple-dose, three-way crossover, exploratory study in healthy subjects

Clinical therapeutics, 2008-05, Vol.30 (5), p.909-916

2008

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Model Informed Dosing Regimen and Phase I Results of the Anti‐PD‐1 Antibody Budigalimab (ABBV‐181)

Clinical and translational science, 2021-01, Vol.14 (1), p.277-287

2021

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Quantification of 4-Beta-Hydroxycholesterol in Human Plasma Using Automated Sample Preparation and LC-ESI-MS/MS Analysis

Chemical research in toxicology, 2011-09, Vol.24 (9), p.1575-1585

2011

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Simultaneous analysis of insect repellent DEET, sunscreen oxybenzone and five relevant metabolites by reversed-phase HPLC with UV detection: Application to an in vivo study in a piglet model

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2005-08, Vol.822 (1), p.271-277

2005

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In vitro permeation of repellent DEET and sunscreen oxybenzone across three artificial membranes

International journal of pharmaceutics, 2006-03, Vol.310 (1), p.110-117

2006

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Bedside to Bench: Integrating Quantitative Clinical Pharmacology and Reverse Translation to Optimize Drug Development

Clinical pharmacology and therapeutics, 2018-02, Vol.103 (2), p.196-198

2018

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How comparable are outcomes for approved PD-1/PD-L1 checkpoint inhibitors (CPI)? A model-informed drug development approach to answer the question

Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.e21152-e21152

2023

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How Well Are We Applying Quantitative Methods to Reverse Translation to Inform Early Clinical Development?

Clinical pharmacology and therapeutics, 2018-02, Vol.103 (2), p.174-176

2018

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Informing Development of Bispecific Antibodies Using Physiologically Based Pharmacokinetic‐Pharmacodynamic Models: Current Capabilities and Future Opportunities

Journal of clinical pharmacology, 2020-10, Vol.60 (S1 Suppl 1), p.S132-S146

2020

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Characterization of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and Subjects With Type 2 Diabetes

Diabetes care, 2013-10, Vol.36 (10), p.3169-3176

2013

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A Population Pharmacokinetic Meta‐Analysis of Veliparib, a PARP Inhibitor, Across Phase 1/2/3 Trials in Cancer Patients

Journal of clinical pharmacology, 2021-09, Vol.61 (9), p.1195-1205

2021

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Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR‐T and TCR‐T Cell Therapies: An Industry Perspective

Clinical pharmacology and therapeutics, 2023-09, Vol.114 (3), p.530-557

2023

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The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus

British journal of clinical pharmacology, 2013-09, Vol.76 (3), p.432-444

2013

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Validation of 4β‐hydroxycholesterol and evaluation of other endogenous biomarkers for the assessment of CYP3A activity in healthy subjects

British journal of clinical pharmacology, 2014-11, Vol.78 (5), p.1122-1134

2014

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ABT-165 plus FOLFIRI versus bevacizumab plus FOLFIRI in patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine/oxaliplatin and bevacizumab

Journal of clinical oncology, 2019-02, Vol.37 (4_suppl), p.TPS720-TPS720

2019

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Assessment of pharmacokinetic interaction between rilotumumab and epirubicin, cisplatin and capecitabine (ECX) in a Phase 3 study in gastric cancer

British journal of clinical pharmacology, 2017-05, Vol.83 (5), p.1048-1055

2017

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Phase I Open-Label Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Dilpacimab in Patients with Advanced Solid Tumors

Molecular cancer therapeutics, 2021-10, Vol.20 (10), p.1988-1995

2021

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Clinical Pharmacokinetics and Pharmacodynamics of Dapagliflozin, a Selective Inhibitor of Sodium-Glucose Co-transporter Type 2

Reverse Translation: The Art of Cyclical Learning

Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study

Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor

Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy

Pharmacokinetic and Pharmacodynamic Properties of Single- and Multiple-Dose of Dapagliflozin, a Selective Inhibitor of SGLT2, in Healthy Chinese Subjects

801 Risk-benefit ratio in immunotherapy (IO) with or without chemotherapy (CT) according to PD-L1 expression: a model-based approach to inform treatment decisions in metastatic non-small cell lung cancer

Influence of Hepatic Impairment on the Pharmacokinetics and Safety Profile of Dapagliflozin: An Open-Label, Parallel-Group, Single-Dose Study

Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: A randomized, open-label, multiple-dose, three-way crossover, exploratory study in healthy subjects

Model Informed Dosing Regimen and Phase I Results of the Anti‐PD‐1 Antibody Budigalimab (ABBV‐181)

Quantification of 4-Beta-Hydroxycholesterol in Human Plasma Using Automated Sample Preparation and LC-ESI-MS/MS Analysis

Simultaneous analysis of insect repellent DEET, sunscreen oxybenzone and five relevant metabolites by reversed-phase HPLC with UV detection: Application to an in vivo study in a piglet model

In vitro permeation of repellent DEET and sunscreen oxybenzone across three artificial membranes

Bedside to Bench: Integrating Quantitative Clinical Pharmacology and Reverse Translation to Optimize Drug Development

How comparable are outcomes for approved PD-1/PD-L1 checkpoint inhibitors (CPI)? A model-informed drug development approach to answer the question

How Well Are We Applying Quantitative Methods to Reverse Translation to Inform Early Clinical Development?

Informing Development of Bispecific Antibodies Using Physiologically Based Pharmacokinetic‐Pharmacodynamic Models: Current Capabilities and Future Opportunities

Characterization of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and Subjects With Type 2 Diabetes

A Population Pharmacokinetic Meta‐Analysis of Veliparib, a PARP Inhibitor, Across Phase 1/2/3 Trials in Cancer Patients

Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR‐T and TCR‐T Cell Therapies: An Industry Perspective

The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus

Validation of 4β‐hydroxycholesterol and evaluation of other endogenous biomarkers for the assessment of CYP3A activity in healthy subjects

ABT-165 plus FOLFIRI versus bevacizumab plus FOLFIRI in patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine/oxaliplatin and bevacizumab

Assessment of pharmacokinetic interaction between rilotumumab and epirubicin, cisplatin and capecitabine (ECX) in a Phase 3 study in gastric cancer

Phase I Open-Label Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Dilpacimab in Patients with Advanced Solid Tumors

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