Bottom-up Meets Top-down: Complementary Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling for Regulatory Approval of a Dosing Algorithm of Valganciclovir in Very Young Children

A Physiologically Based Pharmacokinetic Model for Ganciclovir and Its Prodrug Valganciclovir in Adults and Children

(2016) V. Lukacova et al.   AAPS Journal

Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients 4 Months of Age and Younger

(2016) Denise Bradley et al.   PEDIATRIC INFECTIOUS DISEASE JOURNAL

Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease

(2015) David W. Kimberlin et al.   NEW ENGLAND JOURNAL OF MEDICINE

Dosing in Children: A Critical Review of the Pharmacokinetic Allometric Scaling and Modelling Approaches in Paediatric Drug Development and Clinical Settings

(2014) Iftekhar Mahmood   CLINICAL PHARMACOKINETICS

Population Pharmacokinetic Analysis during the First 2 Years of Life

(2012) Amélie Marsot et al.   CLINICAL PHARMACOKINETICS

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

(2012) R Leong et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

(2011) Malcolm Rowland et al.   Annual Review of Pharmacology and Toxicology

Paediatric drug development: are population models predictive of pharmacokinetics across paediatric populations?

(2011) Massimo Cella et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Development of a Physiologically Based Model for Oseltamivir and Simulation of Pharmacokinetics in Neonates and Infants

(2011) Neil Parrott et al.   CLINICAL PHARMACOKINETICS

Modelling and simulation as research tools in paediatric drug development

(2011) Francesco Bellanti et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Pediatric Dose Selection

(2010) D R Abernethy et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The role of population PK–PD modelling in paediatric clinical research

(2010) Roosmarijn F. W. De Cock et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice

(2010) Trevor N. Johnson et al.   PEDIATRIC ANESTHESIA

Ganciclovir Pharmacokinetic Parameters Do Not Change When Extending Valganciclovir Cytomegalovirus Prophylaxis From 100 to 200 Days

(2010) Horst Welker et al.   TRANSPLANTATION

Valganciclovir Dosing According to Body Surface Area and Renal Function in Pediatric Solid Organ Transplant Recipients

(2009) W. Vaudry et al.   AMERICAN JOURNAL OF TRANSPLANTATION

Cytomegalovirus in Solid Organ Transplant Recipients

(2009) A. Humar et al.   AMERICAN JOURNAL OF TRANSPLANTATION

Population Pharmacokinetics of Ganciclovir after Intravenous Ganciclovir and Oral Valganciclovir Administration in Solid Organ Transplant Patients Infected with Cytomegalovirus

(2009) A. Caldes et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

(2009) Efthymios Manolis et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

What is the right dose for children?

(2009) Massimo Cella et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Optimizing Pediatric Dosing: A Developmental Pharmacologic Approach

(2009) Gail D Anderson et al.   PHARMACOTHERAPY

Pharmacokinetics of oral valganciclovir solution and intravenous ganciclovir in pediatric renal and liver transplant recipients

(2009) M.D. Pescovitz et al.   Transplant Infectious Disease

Whole body physiologically-based pharmacokinetic models: their use in clinical drug development

(2008) Andrea N Edginton et al.   Expert Opinion on Drug Metabolism & Toxicology