Ammonia Control in Children with Urea Cycle Disorders (UCDs); Phase 2 Comparison of Sodium Phenylbutyrate and Glycerol Phenylbutyrate Publication Ammonia Control in Children with Urea Cycle Disorders (UCDs); Phase 2 Comparison of Sodium Phenylbutyrate and Glycerol Phenylbutyrate Twenty four hour ammonia profiles and correlates of drug effect were examined in a phase…CertaraAugust 1, 2011
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 Publication 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 This study had two primary aims: (i) To describe an example of the development work…CertaraMarch 1, 2011
Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome Publication Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome Teduglutide, a synthetic glucagon-like peptide-2 (GLP-2) analog with activity relating to the regeneration, maintenance, and…CertaraDecember 1, 2009
Population Pharmacokinetics of Intravenous Pantoprazole in Pediatric Intensive Care Patients Publication Population Pharmacokinetics of Intravenous Pantoprazole in Pediatric Intensive Care Patients What is already known about this subject The use of intravenous pantoprazole, a proton pump…CertaraFebruary 1, 2009
Intestinal Metabolism and Transport of Drugs in Children: The Effects of Age and Disease Publication Intestinal Metabolism and Transport of Drugs in Children: The Effects of Age and Disease The presence of cytochrome P450 enzymes in the small bowel results in the reduced bioavailability…CertaraJuly 1, 2008
Development of CYP2D6 and CYP3A4 in the First Year of Life Publication Development of CYP2D6 and CYP3A4 in the First Year of Life Recently, Blake et al . ‘‘Ontogeny of dextromethorphan O- and N-demethylation in the first year…CertaraMay 1, 2008
The Problems in Scaling Adult Drug Doses to Children Publication The Problems in Scaling Adult Drug Doses to Children Many drugs are unlicensed in children and consequently their doses have been scaled down from…CertaraMarch 15, 2007
Prediction of Clearance of Eleven Drugs and Associated Variability in Neonates Publication Prediction of Clearance of Eleven Drugs and Associated Variability in Neonates Prediction of the exposure of neonates, infants and children to xenobiotics is likely to be…CertaraSeptember 1, 2006
Changes in Liver Volume from Birth to Adulthood: A Meta-analysis Publication Changes in Liver Volume from Birth to Adulthood: A Meta-analysis A diversity of equations is available for the estimation of liver volume (LV), derived from…CertaraDecember 1, 2005
Model-based Covariate Pharmacokinetic Analysis and Lack of Cortisol Suppression by the New Inhaled Corticosteroid Ciclesonide Using a Novel Cortisol Release Model Publication Model-based Covariate Pharmacokinetic Analysis and Lack of Cortisol Suppression by the New Inhaled Corticosteroid Ciclesonide Using a Novel Cortisol Release Model Ciclesonide is a novel and effective inhaled corticosteroid for the treatment of asthma that is…CertaraSeptember 1, 2005