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Pediatric Drug–Drug Interaction Studies: Barriers and Opportunities

Clinical pharmacology and therapeutics, 2019-05, Vol.105 (5), p.1067-1070

2019

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Extrapolation of adult data and other data in pediatric drug-development programs

Pediatrics (Evanston), 2011-11, Vol.128 (5), p.e1242-e1249

2011

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Renal Clearance in Newborns and Infants: Predictive Performance of Population‐Based Modeling for Drug Development

Clinical pharmacology and therapeutics, 2019-06, Vol.105 (6), p.1462-1470

2019

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Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir

Journal of clinical pharmacology, 2020-02, Vol.60 (2), p.240-255

2020

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Creatinine‐Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs

Clinical pharmacology and therapeutics, 2021-01, Vol.109 (1), p.263-269

2021

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Pediatric Renal Ontogeny and Applications in Drug Development

Journal of clinical pharmacology, 2019-09, Vol.59 (S1), p.S9-S20

2019

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Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020

Clinical and translational science, 2023-10, Vol.16 (10), p.2046-2057

2023

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Epigenetic Changes in Gene Expression for Drug-Metabolizing Enzymes and Transporters

Pharmacotherapy, 2014-02, Vol.34 (2), p.140-150

2014

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Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Pharmacotherapy, 2008-08, Vol.28 (8), p.992-998

2008

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Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling

Frontiers in pediatrics, 2021-07, Vol.9, p.698611-698611

2021

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Need for Representation of Pediatric Patients with Obesity in Clinical Trials

Children (Basel), 2023-09, Vol.10 (10), p.1640

2023

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Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs

Pharmaceutics, 2020-07, Vol.12 (7), p.685

2020

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Tacrolimus Dosing in Pediatric Heart Transplant Patients is Related to CYP3A5 and MDR1 Gene Polymorphisms

American journal of transplantation, 2003-04, Vol.3 (4), p.477-483

2003

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A Randomized Trial of Inhaled Cyclosporine in Lung-Transplant Recipients

The New England journal of medicine, 2006-01, Vol.354 (2), p.141-150

2006

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Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity

Clinical pharmacology and therapeutics, 2023-05, Vol.113 (5), p.957-959

2023

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Assessing Information Gaps Associated with Initial Pediatric Study Plans for New Oncology Drug and Biological Products

Clinical pharmacology and therapeutics, 2023-09, Vol.114 (3), p.618-622

2023

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Addressing the Knowledge Gaps for Providing Optimal Drug Pharmacotherapy for the Obese

Journal of clinical pharmacology, 2023-11, Vol.63 (S2), p.S6-S7

2023

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Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities

Journal of clinical pharmacology, 2023-11, Vol.63 (S2), p.S10-S17

2023

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In Memoriam: Varsha Bhatt-Mehta, PharmD, MS, FCCP

Journal of clinical pharmacology, 2023-11, Vol.63 (S2), p.S8-S9

2023

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Genetic polymorphisms influence mycophenolate mofetil–related adverse events in pediatric heart transplant patients

The Journal of heart and lung transplantation, 2010-05, Vol.29 (5), p.509-516

2010

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Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

Journal of clinical pharmacology, 2021-06, Vol.61 (S1), p.S28-S35

2021

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Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics?

Frontiers in pediatrics, 2021-10, Vol.9

2021

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Nuclear Factor Kappa B: Important Transcription Factor and Therapeutic Target

Journal of clinical pharmacology, 1998-11, Vol.38 (11), p.981-993

1998

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Effect of Obesity on the Pharmacokinetics and Pharmacodynamics of Anticancer Agents

Journal of clinical pharmacology, 2023-11, Vol.63 (S2), p.S85-S102

2023

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Physiologically Based Pharmacokinetic Modeling of Nilotinib for Drug‐Drug Interactions, Pediatric Patients, and Pregnancy and Lactation

Journal of clinical pharmacology, 2024-03, Vol.64 (3), p.323-333

2024

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Pediatric Drug–Drug Interaction Studies: Barriers and Opportunities

Extrapolation of adult data and other data in pediatric drug-development programs

Renal Clearance in Newborns and Infants: Predictive Performance of Population‐Based Modeling for Drug Development

Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir

Creatinine‐Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs

Pediatric Renal Ontogeny and Applications in Drug Development

Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020

Epigenetic Changes in Gene Expression for Drug-Metabolizing Enzymes and Transporters

Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling

Need for Representation of Pediatric Patients with Obesity in Clinical Trials

Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs

Tacrolimus Dosing in Pediatric Heart Transplant Patients is Related to CYP3A5 and MDR1 Gene Polymorphisms

A Randomized Trial of Inhaled Cyclosporine in Lung-Transplant Recipients

Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity

Assessing Information Gaps Associated with Initial Pediatric Study Plans for New Oncology Drug and Biological Products

Addressing the Knowledge Gaps for Providing Optimal Drug Pharmacotherapy for the Obese

Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities

In Memoriam: Varsha Bhatt-Mehta, PharmD, MS, FCCP

Genetic polymorphisms influence mycophenolate mofetil–related adverse events in pediatric heart transplant patients

Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics?

Nuclear Factor Kappa B: Important Transcription Factor and Therapeutic Target

Effect of Obesity on the Pharmacokinetics and Pharmacodynamics of Anticancer Agents

Physiologically Based Pharmacokinetic Modeling of Nilotinib for Drug‐Drug Interactions, Pediatric Patients, and Pregnancy and Lactation

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