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Concentration-QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

Journal of clinical pharmacology, 2008-01, Vol.48 (1), p.13-18

2008

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Pharmacokinetics and Bioavailability of Herbal Medicinal Products

Phytomedicine (Stuttgart), 2002, Vol.9, p.1-33

2002

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Application of Model‐Informed Drug Development in Dose Selection and Optimization for siRNA Therapies

Journal of clinical pharmacology, 2024-07, Vol.64 (7), p.799-809

2024

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Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases

Journal of clinical pharmacology, 2022-12, Vol.62 (S2), p.S27-S37

2022

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Association of genetic mutations and loss of ambulation in childhood‐onset dystrophinopathy

Muscle & nerve, 2021-02, Vol.63 (2), p.181-191

2021

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Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective

Clinical pharmacology and therapeutics, 2022-10, Vol.112 (4), p.853-863

2022

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Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective

Journal of clinical pharmacology, 2023-11, Vol.63 (S2), p.S65-S77

2023

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Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Drug metabolism and disposition, 2016-07, Vol.44 (7), p.924-933

2016

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Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling

Journal of clinical pharmacology, 2019-09, Vol.59 (S1), p.S104-S111

2019

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Model‐Informed Drug Development in Pediatric Dose Selection

Journal of clinical pharmacology, 2021-06, Vol.61 (S1), p.S60-S69

2021

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CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations

The journal of clinical psychiatry, 2012-09, Vol.73 (9), p.1187

2012

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Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

The journal of clinical psychiatry, 2011-09, Vol.72 (9), p.1166

2011

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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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Isolation and characterization of metabolites of centpropazine in rat liver, intestine, and red blood cell homogenates

Journal of pharmaceutical sciences, 2002-09, Vol.91 (9), p.2067-2075

2002

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Evaluation of absorbability of centpropazine in rats: in-situ and in-vivo approaches

Journal of pharmacy and pharmacology, 2001-06, Vol.53 (6), p.901-906

2001

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Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease

Journal of Parkinson's disease, 2015-01, Vol.5 (3), p.581

2015

Volltextzugriff (PDF)

Evaluation of pharmacokinetics, brain levels and protein binding of centpropazine in rats

Biopharmaceutics & drug disposition, 2004-03, Vol.25 (2), p.69-75

2004

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Endpoints and Analyses to Discern Disease-Modifying Drug Effects in Early Parkinson’s Disease

The AAPS journal, 2009-09, Vol.11 (3), p.456-464, Article 456

2009

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Population pharmacokinetics of cilengitide in adult and pediatric cancer patients from a nonlinear mixed-effects analysis

Journal of clinical pharmacology, 2014-12, Vol.54 (12), p.1391-1399

2014

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Knowledge management for efficient quantitative analyses during regulatory reviews

Expert review of clinical pharmacology, 2011-11, Vol.4 (6), p.697-703

2011

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Abstract B214: Use of a pharmacokinetic model derived from early clinical studies to assess the relevance of covariates on cilengitide pharmacokinetics

Molecular cancer therapeutics, 2009-12, Vol.8 (12_Supplement), p.B214-B214

2009

Volltextzugriff (PDF)

Pharmacokinetic Studies of Florfenicol in Koi Carp and Threespot Gourami Trichogaster trichopterus after Oral and Intramuscular Treatment

Journal of aquatic animal health, 2005-06, Vol.17 (2), p.129-137

2005

Volltextzugriff (PDF)

Determination of centpropazine and its metabolite in rat serum by high-performance liquid chromatography and fluorescence detection

Journal of chromatography. B, Biomedical sciences and applications, 2000-10, Vol.748 (2), p.331-335

2000

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Population Pharmacokinetics of Eniporide and Its Metabolite in Healthy Subjects and Patients With Acute Myocardial Infarction

Journal of clinical pharmacology, 2005-06, Vol.45 (6), p.631-639

2005

Volltextzugriff (PDF)

Application of two-point assay of digoxin serum concentration in studying population pharmacokinetics in Egyptian pediatric patients with heart failure: does it make sense?

American journal of therapeutics, 2005-07, Vol.12 (4), p.320

2005

Volltextzugriff (PDF)

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Concentration-QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

Pharmacokinetics and Bioavailability of Herbal Medicinal Products

Application of Model‐Informed Drug Development in Dose Selection and Optimization for siRNA Therapies

Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases

Association of genetic mutations and loss of ambulation in childhood‐onset dystrophinopathy

Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective

Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective

Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling

Model‐Informed Drug Development in Pediatric Dose Selection

CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

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

Isolation and characterization of metabolites of centpropazine in rat liver, intestine, and red blood cell homogenates

Evaluation of absorbability of centpropazine in rats: in-situ and in-vivo approaches

Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease

Evaluation of pharmacokinetics, brain levels and protein binding of centpropazine in rats

Endpoints and Analyses to Discern Disease-Modifying Drug Effects in Early Parkinson’s Disease

Population pharmacokinetics of cilengitide in adult and pediatric cancer patients from a nonlinear mixed-effects analysis

Knowledge management for efficient quantitative analyses during regulatory reviews

Abstract B214: Use of a pharmacokinetic model derived from early clinical studies to assess the relevance of covariates on cilengitide pharmacokinetics

Pharmacokinetic Studies of Florfenicol in Koi Carp and Threespot Gourami Trichogaster trichopterus after Oral and Intramuscular Treatment

Determination of centpropazine and its metabolite in rat serum by high-performance liquid chromatography and fluorescence detection

Population Pharmacokinetics of Eniporide and Its Metabolite in Healthy Subjects and Patients With Acute Myocardial Infarction

Application of two-point assay of digoxin serum concentration in studying population pharmacokinetics in Egyptian pediatric patients with heart failure: does it make sense?

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