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Failed Pediatric Drug Development Trials

Clinical pharmacology and therapeutics, 2015-09, Vol.98 (3), p.245-251

2015

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Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

Clinical pharmacology and therapeutics, 2012-05, Vol.91 (5), p.926-931

2012

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Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications

Clinical pharmacology and therapeutics, 2009-03, Vol.85 (3), p.305-311

2009

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Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

Clinical pharmacology and therapeutics, 2017-06, Vol.101 (6), p.736-744

2017

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Pharmacogenomic information in FDA-approved drug labels: Application to pediatric patients

Clinical pharmacology and therapeutics, 2016-06, Vol.99 (6), p.622-632

2016

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A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development

Clinical pharmacology and therapeutics, 2015-09, Vol.98 (3), p.328-335

2015

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IMPDH1 Gene Polymorphisms and Association With Acute Rejection in Renal Transplant Patients

Clinical pharmacology and therapeutics, 2008-05, Vol.83 (5), p.711-717

2008

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The Influence of Race and Common Genetic Variations on Outcomes After Pediatric Heart Transplantation

American journal of transplantation, 2017-06, Vol.17 (6), p.1525-1539

2017

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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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Pediatric Dose Selection

Clinical pharmacology and therapeutics, 2010-03, Vol.87 (3), p.270-271

2010

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P-glycoprotein and Drug Therapy in Organ Transplantation

Journal of clinical pharmacology, 1999-10, Vol.39 (10), p.995-1005

1999

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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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Biomarkers in Solid‐Organ Transplantation

Clinical pharmacology and therapeutics, 2011-08, Vol.90 (2), p.217-220

2011

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Preservation of post-transplant lung function with aerosol cyclosporin

The European respiratory journal, 2004-03, Vol.23 (3), p.378-383

2004

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Tacrolimus Dosing in Adult Lung Transplant Patients Is Related to Cytochrome P4503A5 Gene Polymorphism

Journal of clinical pharmacology, 2004-02, Vol.44 (2), p.135-140

2004

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Cyclosporine A inhibits the expression of costimulatory molecules on in vitro-generated dendritic cells: association with reduced nuclear translocation of nuclear factor kappa B

Transplantation, 1999-11, Vol.68 (9), p.1255

1999

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The impact of pharmacogenomic factors on steroid dependency in pediatric heart transplant patients using logistic regression analysis

Pediatric transplantation, 2004-12, Vol.8 (6), p.551-557

2004

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The impact of pharmacogenomic factors on acute persistent rejection in adult lung transplant patients

Transplant immunology, 2005-03, Vol.14 (1), p.37-42

2005

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Tacrolimus: a new immunosuppressive agent

American journal of health-system pharmacy, 1995-07, Vol.52 (14), p.1521-1535

1995

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The MDR1 polymorphisms at exons 21 and 26 predict steroid weaning in pediatric heart transplant patients

Human immunology, 2002-09, Vol.63 (9), p.765-770

2002

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Pharmacogenomics and lung transplantation: clinical implications

The pharmacogenomics journal, 2006-09, Vol.6 (5), p.301-310

2006

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Species differences in the hepatic and intestinal metabolism of cyclosporine

Xenobiotica, 1999, Vol.29 (1), p.3-9

1999

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A comparison of ganciclovir and acyclovir to prevent cytomegalovirus after lung transplantation

American journal of respiratory and critical care medicine, 1994-07, Vol.150 (1), p.146-152

1994

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Aerosolized cyclosporine in lung recipients with refractory chronic rejection

American journal of respiratory and critical care medicine, 1996-04, Vol.153 (4 Pt 1), p.1451-1455

1996

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Species-dependent hepatic metabolism of immunosuppressive agent tacrolimus (FK-506)

Xenobiotica, 2009-10, Vol.39 (10), p.757-765

2009

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Failed Pediatric Drug Development Trials

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

Pharmacogenomic information in FDA-approved drug labels: Application to pediatric patients

A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development

IMPDH1 Gene Polymorphisms and Association With Acute Rejection in Renal Transplant Patients

The Influence of Race and Common Genetic Variations on Outcomes After Pediatric Heart Transplantation

Nuclear Factor Kappa B: Important Transcription Factor and Therapeutic Target

Pediatric Dose Selection

P-glycoprotein and Drug Therapy in Organ Transplantation

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

Biomarkers in Solid‐Organ Transplantation

Preservation of post-transplant lung function with aerosol cyclosporin

Tacrolimus Dosing in Adult Lung Transplant Patients Is Related to Cytochrome P4503A5 Gene Polymorphism

Cyclosporine A inhibits the expression of costimulatory molecules on in vitro-generated dendritic cells: association with reduced nuclear translocation of nuclear factor kappa B

The impact of pharmacogenomic factors on steroid dependency in pediatric heart transplant patients using logistic regression analysis

The impact of pharmacogenomic factors on acute persistent rejection in adult lung transplant patients

Tacrolimus: a new immunosuppressive agent

The MDR1 polymorphisms at exons 21 and 26 predict steroid weaning in pediatric heart transplant patients

Pharmacogenomics and lung transplantation: clinical implications

Species differences in the hepatic and intestinal metabolism of cyclosporine

A comparison of ganciclovir and acyclovir to prevent cytomegalovirus after lung transplantation

Aerosolized cyclosporine in lung recipients with refractory chronic rejection

Species-dependent hepatic metabolism of immunosuppressive agent tacrolimus (FK-506)

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