Publications by authors named "S C Goulooze"
Article Synopsis
- - Daprodustat, a new treatment for anemia in chronic kidney disease (CKD) patients, was analyzed to understand how various factors affect its pharmacokinetics in adults, focusing on its absorption, distribution, metabolism, and excretion in dialysis and non-dialysis patients.
- - The study involved data from multiple clinical trials with 707 participants, examining how body weight and the use of certain medications (like clopidogrel) influenced daprodustat's clearance and absorption.
- - Results indicated that daprodustat followed a three-compartment distribution model with specific influences from body weight and dialysis status, while other factors did not significantly impact the drug's effectiveness.
Time-varying covariates, overadjustment bias and mediation in pharmacokinetic/pharmacodynamic modeling.
CPT Pharmacometrics Syst Pharmacol
August 2024
Aims: Whether and when glomerular filtration rate (GFR) in preterms catches up with term peers is unknown. This study aims to develop a GFR maturation model for (pre)term-born individuals from birth to 18 years of age. Secondarily, the function is applied to data of different renally excreted drugs.
View Article and Find Full Text PDFIntroduction: Pharmacokinetic (PK)-Pharmacodynamic (PD) and exposure-response (E-R) modeling are critical parts of pediatric drug development. By integrating available knowledge and supportive data to support the design of future studies and pediatric dose selection, these techniques increase the efficiency of pediatric drug development and lowers the risk of exposing pediatric study participants to suboptimal or unsafe dose regimens.
Areas Covered: The role of PK, PK-PD and E-R modeling within pediatric drug development and pediatric dose selection is discussed.
Aims: To perform dose-exposure-response analyses to determine the effects of finerenone doses.
Materials And Methods: Two randomized, double-blind, placebo-controlled phase 3 trials enrolling 13 026 randomized participants with type 2 diabetes (T2D) from global sites, each with an estimated glomerular filtration rate (eGFR) of 25 to 90 mL/min/1.73 m , a urine albumin-creatinine ratio (UACR) of 30 to 5000 mg/g, and serum potassium ≤ 4.