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FDA Approval: Blinatumomab

Clinical cancer research, 2015-09, Vol.21 (18), p.4035-4039

2015

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Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents

Clinical cancer research, 2017-01, Vol.23 (1), p.9-12

2017

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Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Clinical cancer research, 2016-06, Vol.22 (11), p.2623-2629

2016

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Minimal brain PBPK model to support the preclinical and clinical development of antibody therapeutics for CNS diseases

Journal of pharmacokinetics and pharmacodynamics, 2021-12, Vol.48 (6), p.861-871

2021

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Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward

The American heart journal, 2014-09, Vol.168 (3), p.262-272

2014

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Evaluation of Vancomycin Dosing Regimens in Preterm and Term Neonates Using Monte Carlo Simulations

Pharmacotherapy, 2012-05, Vol.32 (5), p.408-419

2012

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Quadrupolar asymmetry in shifted-stem vane-shaped-rod radio frequency quadrupole accelerator

Nuclear instruments & methods in physics research. Section A, Accelerators, spectrometers, detectors and associated equipment, 2018-04, Vol.886, p.119-124

Mehrotra, Nitin

2018

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A tandem mass spectrometry assay for the simultaneous determination of acetaminophen, caffeine, phenytoin, ranitidine, and theophylline in small volume pediatric plasma specimens

Clinica chimica acta, 2008-12, Vol.398 (1), p.105-112

2008

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Replicate Testing of Clinical Endpoints Can Prevent No-Go Decisions for Beneficial Vaccines

Vaccines (Basel), 2023-09, Vol.11 (9), p.1501

2023

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Identifying and characterising sources of variability in digital outcome measures in Parkinson’s disease

NPJ digital medicine, 2022-07, Vol.5 (1), p.93-93, Article 93

2022

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Liquid chromatography/tandem mass spectrometric study and analysis of xanthone and secoiridoid glycoside composition of Swertia chirata, a potent antidiabetic

Rapid communications in mass spectrometry, 2006-01, Vol.20 (24), p.3761-3768

2006

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Predictors of Mortality in Elderly Subjects with Obstructive Airway Disease: The PILE Score

Annals of epidemiology, 2010-03, Vol.20 (3), p.223-232

2010

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FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Clinical cancer research, 2015-06, Vol.21 (12), p.2666-2670

2015

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Neurodegenerative Diseases: The Value of Early Predictive End Points

Clinical pharmacology and therapeutics, 2022-04, Vol.111 (4), p.835-839

2022

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Driving Efficiency: Leveraging Model‐Informed Approaches in 505(b)(2) Regulatory Actions

Journal of clinical pharmacology, 2024-08

2024

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IMPROVING OUR UNDERSTANDING OF THE RELATIONSHIP BETWEEN QT PROLONGATION AND RISK OF TORSADE DE POINTES USING A QUANTITATIVE MODELING APPROACH

Journal of the American College of Cardiology, 2014-04, Vol.63 (12), p.A305-A305

2014

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FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

Clinical cancer research, 2014-09, Vol.20 (17), p.4436-4441

2014

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FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma

Clinical cancer research, 2015-04, Vol.21 (7), p.1525-1529

2015

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Quantitative Understanding of QTc Prolongation and Gender as Risk Factors for Torsade de Pointes

Clinical pharmacology and therapeutics, 2018-02, Vol.103 (2), p.304-309

2018

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FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease

Clinical cancer research, 2015-03, Vol.21 (5), p.950-954

2015

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Pattern profiling of the herbal preparation picroliv using liquid chromatography–tandem mass spectrometry

Journal of Chromatography A, 2004-08, Vol.1045 (1), p.145-152

2004

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In Vitro and In Vivo pharmacokinetic studies of bulaquine (analogue of primaquine), a novel antirelapse antimalarial, in rat, rabbit and monkey-highlighting species similarities and differences

Biopharmaceutics & drug disposition, 2007-07, Vol.28 (5), p.209-227

2007

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PDUFA VI: It Is Time to Unleash the Full Potential of Model‐Informed Drug Development

CPT: pharmacometrics and systems pharmacology, 2019-01, Vol.8 (1), p.5-8

2019

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Use of a Systems Pharmacology Model Based Approach Toward Dose Optimization of Parathyroid Hormone Therapy in Hypoparathyroidism

Clinical pharmacology and therapeutics, 2019-03, Vol.105 (3), p.710-718

2019

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FDA Approval: Blinatumomab

Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents

Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Minimal brain PBPK model to support the preclinical and clinical development of antibody therapeutics for CNS diseases

Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward

Evaluation of Vancomycin Dosing Regimens in Preterm and Term Neonates Using Monte Carlo Simulations

Quadrupolar asymmetry in shifted-stem vane-shaped-rod radio frequency quadrupole accelerator

A tandem mass spectrometry assay for the simultaneous determination of acetaminophen, caffeine, phenytoin, ranitidine, and theophylline in small volume pediatric plasma specimens

Replicate Testing of Clinical Endpoints Can Prevent No-Go Decisions for Beneficial Vaccines

Identifying and characterising sources of variability in digital outcome measures in Parkinson’s disease

Liquid chromatography/tandem mass spectrometric study and analysis of xanthone and secoiridoid glycoside composition of Swertia chirata, a potent antidiabetic

Considerations for assessing the potential effects of antidiabetes drugs on cardiac ventricular repolarization: A report from the Cardiac Safety Research Consortium

Predictors of Mortality in Elderly Subjects with Obstructive Airway Disease: The PILE Score

FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Neurodegenerative Diseases: The Value of Early Predictive End Points

Driving Efficiency: Leveraging Model‐Informed Approaches in 505(b)(2) Regulatory Actions

IMPROVING OUR UNDERSTANDING OF THE RELATIONSHIP BETWEEN QT PROLONGATION AND RISK OF TORSADE DE POINTES USING A QUANTITATIVE MODELING APPROACH

FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma

Quantitative Understanding of QTc Prolongation and Gender as Risk Factors for Torsade de Pointes

FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease

Pattern profiling of the herbal preparation picroliv using liquid chromatography–tandem mass spectrometry

In Vitro and In Vivo pharmacokinetic studies of bulaquine (analogue of primaquine), a novel antirelapse antimalarial, in rat, rabbit and monkey-highlighting species similarities and differences

PDUFA VI: It Is Time to Unleash the Full Potential of Model‐Informed Drug Development

Use of a Systems Pharmacology Model Based Approach Toward Dose Optimization of Parathyroid Hormone Therapy in Hypoparathyroidism

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