Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials
Cindy Hoi Ting Yeung, Ruud H J Verstegen, Rachel G. Greenberg, Tamorah Lewis
Abstract
Core clinical pharmacology principles must be considered when designing and executing neonatal clinical trials. In this review, the authors discuss important aspects of drug dose selection, pharmacokinetics, pharmacogenetics and pharmacodynamics that stakeholders may consider when undertaking a neonatal or infant clinical trial.
Topics & Concepts
MedicinePharmacodynamicsClinical trialPharmacokineticsClinical pharmacologyIntensive care medicinePharmacologyClinical study designPharmacogeneticsDrugInternal medicineBiochemistryGenotypeGeneChemistryPharmaceutical studies and practicesPharmacological Effects and Toxicity StudiesPharmacogenetics and Drug Metabolism