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Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies

Cancer chemotherapy and pharmacology, 2016-04, Vol.77 (4), p.767-776

2016

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Development, Verification, and Prediction of Osimertinib Drug–Drug Interactions Using PBPK Modeling Approach to Inform Drug Label

CPT: pharmacometrics and systems pharmacology, 2018-05, Vol.7 (5), p.321-330

2018

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Managing the Risk of CYP3A Induction in Drug Development: A Strategic Approach

Drug metabolism and disposition, 2017-01, Vol.45 (1), p.35-41

2017

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The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib

British journal of clinical pharmacology, 2018-06, Vol.84 (6), p.1156-1169

2018

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Population pharmacokinetics and exposure–response of selumetinib and its N‐desmethyl metabolite in pediatric patients with neurofibromatosis type 1 and inoperable plexiform neurofibromas

Cancer chemotherapy and pharmacology, 2021-08, Vol.88 (2), p.189-202

2021

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Effect of multiple‐dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin

British journal of clinical pharmacology, 2018-12, Vol.84 (12), p.2877-2888

2018

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Mechanistic physiology-based pharmacokinetic modeling to elucidate vincristine-induced peripheral neuropathy following treatment with novel kinase inhibitors

Cancer chemotherapy and pharmacology, 2021-09, Vol.88 (3), p.451-464

2021

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A mechanistic PK/PD model of AZD0171 (anti‐LIF) to support Phase II dose selection

CPT: pharmacometrics and systems pharmacology, 2024-10, Vol.13 (10), p.1670-1681

2024

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Absolute Bioavailability of Osimertinib in Healthy Adults

Clinical pharmacology in drug development, 2019-02, Vol.8 (2), p.198-207

2019

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Evaluation of the Drug–Drug Interaction Potential of Acalabrutinib and Its Active Metabolite, ACP‐5862, Using a Physiologically‐Based Pharmacokinetic Modeling Approach

CPT: pharmacometrics and systems pharmacology, 2019-07, Vol.8 (7), p.489-499

2019

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The metabotropic glutamate receptor 7 allosteric modulator AMN082: a monoaminergic agent in disguise?

The Journal of pharmacology and experimental therapeutics, 2011-07, Vol.338 (1), p.345-352

2011

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Brain exposure of osimertinib in patients with epidermal growth factor receptor mutation non‐small cell lung cancer and brain metastases: A positron emission tomography and magnetic resonance imaging study

Clinical and translational science, 2023-06, Vol.16 (6), p.955-965

2023

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Impact of Disease and Treatment Response in Drug–Drug Interaction Studies: Osimertinib and Simvastatin in Advanced Non‐Small Cell Lung Cancer

Clinical and translational science, 2020-01, Vol.13 (1), p.41-46

2020

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A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment

Pharmacology research & perspectives, 2020-08, Vol.8 (4), p.e00613-n/a

2020

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Determination of arginine and methylated arginines in human plasma by liquid chromatography–tandem mass spectrometry

Journal of chromatography. B, Biomedical sciences and applications, 2000-10, Vol.748 (1), p.157-166

2000

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Assessing Trends in Cytokine-CYP Drug Interactions and Relevance to Drug Dosing

Drug metabolism and disposition, 2024-10, Vol.52 (11), p.1196-1200

2024

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Osimertinib in Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer and Leptomeningeal Metastases: The BLOOM Study

Journal of clinical oncology, 2020-02, Vol.38 (6), p.538-547

2020

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Determination of moxifloxacin in human plasma by liquid chromatography electrospray ionization tandem mass spectrometry

Journal of pharmaceutical and biomedical analysis, 2002-11, Vol.30 (4), p.961-968

2002

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Harnessing Meta‐analysis to Refine an Oncology Patient Population for Physiology‐Based Pharmacokinetic Modeling of Drugs

Clinical pharmacology and therapeutics, 2018-02, Vol.103 (2), p.271-280

2018

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Population pharmacokinetics and exposure‐response of osimertinib in patients with non‐small cell lung cancer

British journal of clinical pharmacology, 2017-06, Vol.83 (6), p.1216-1226

2017

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Single-Dose Pharmacokinetics, Excretion, and Metabolism of Zoliflodacin, a Novel Spiropyrimidinetrione Antibiotic, in Healthy Volunteers

Antimicrobial agents and chemotherapy, 2019-01, Vol.63 (1)

2019

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Osimertinib for Patients With Leptomeningeal Metastases Associated With EGFR T790M-Positive Advanced NSCLC: The AURA Leptomeningeal Metastases Analysis

Journal of thoracic oncology, 2020-04, Vol.15 (4), p.637-648

2020

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Exposure-response modelling of osimertinib in patients with non-small cell lung cancer

British journal of clinical pharmacology, 2024-08

2024

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Resistance models to EGFR inhibition and chemotherapy in non-small cell lung cancer via analysis of tumour size dynamics

Cancer chemotherapy and pharmacology, 2019-07, Vol.84 (1), p.51-60

2019

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Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer

Clinical pharmacology and therapeutics, 2024-02, Vol.115 (2), p.349-360

2024

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Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies

Development, Verification, and Prediction of Osimertinib Drug–Drug Interactions Using PBPK Modeling Approach to Inform Drug Label

Managing the Risk of CYP3A Induction in Drug Development: A Strategic Approach

The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib

Population pharmacokinetics and exposure–response of selumetinib and its N‐desmethyl metabolite in pediatric patients with neurofibromatosis type 1 and inoperable plexiform neurofibromas

Effect of multiple‐dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin

Mechanistic physiology-based pharmacokinetic modeling to elucidate vincristine-induced peripheral neuropathy following treatment with novel kinase inhibitors

A mechanistic PK/PD model of AZD0171 (anti‐LIF) to support Phase II dose selection

Absolute Bioavailability of Osimertinib in Healthy Adults

Evaluation of the Drug–Drug Interaction Potential of Acalabrutinib and Its Active Metabolite, ACP‐5862, Using a Physiologically‐Based Pharmacokinetic Modeling Approach

The metabotropic glutamate receptor 7 allosteric modulator AMN082: a monoaminergic agent in disguise?

Brain exposure of osimertinib in patients with epidermal growth factor receptor mutation non‐small cell lung cancer and brain metastases: A positron emission tomography and magnetic resonance imaging study

Impact of Disease and Treatment Response in Drug–Drug Interaction Studies: Osimertinib and Simvastatin in Advanced Non‐Small Cell Lung Cancer

A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment

Determination of arginine and methylated arginines in human plasma by liquid chromatography–tandem mass spectrometry

Assessing Trends in Cytokine-CYP Drug Interactions and Relevance to Drug Dosing

Osimertinib in Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer and Leptomeningeal Metastases: The BLOOM Study

Determination of moxifloxacin in human plasma by liquid chromatography electrospray ionization tandem mass spectrometry

Harnessing Meta‐analysis to Refine an Oncology Patient Population for Physiology‐Based Pharmacokinetic Modeling of Drugs

Population pharmacokinetics and exposure‐response of osimertinib in patients with non‐small cell lung cancer

Single-Dose Pharmacokinetics, Excretion, and Metabolism of Zoliflodacin, a Novel Spiropyrimidinetrione Antibiotic, in Healthy Volunteers

Osimertinib for Patients With Leptomeningeal Metastases Associated With EGFR T790M-Positive Advanced NSCLC: The AURA Leptomeningeal Metastases Analysis

Exposure-response modelling of osimertinib in patients with non-small cell lung cancer

Resistance models to EGFR inhibition and chemotherapy in non-small cell lung cancer via analysis of tumour size dynamics

Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer

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