Application of Quantitative Pharmacology Approaches in Bridging Pharmacokinetics and Pharmacodynamics of Domagrozumab From Adult Healthy Subjects to Pediatric Patients With Duchenne Muscular Disease

2017 ◽  
Vol 58 (3) ◽  
pp. 314-326 ◽  
Author(s):  
Indranil Bhattacharya ◽  
Zorayr Manukyan ◽  
Phylinda Chan ◽  
Anne Heatherington ◽  
Lutz Harnisch
Keyword(s):  
Healthy Subjects ◽  
Pediatric Patients ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Quantitative Pharmacology ◽  
Muscular Disease

scholarly journals Model-Informed Optimization of a Pediatric Clinical Pharmacokinetic Trial of a New Spironolactone Liquid Formulation

Pharmaceutics ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 849
Author(s):  
Manasa Tatipalli ◽  
Vijay Kumar Siripuram ◽  
Tao Long ◽  
Diana Shuster ◽  
Galina Bernstein ◽  
...  
Keyword(s):  
Pharmacokinetic Model ◽  
Allometric Scaling ◽  
Pediatric Patients ◽  
Reference Product ◽  
Population Pharmacokinetic ◽  
Liquid Formulation ◽  
Sampling Schemes ◽  
Quantitative Pharmacology ◽  
Using Data ◽  
Drug Pharmacokinetics

Quantitative pharmacology brings important advantages in the design and conduct of pediatric clinical trials. Herein, we demonstrate the application of a model-based approach to select doses and pharmacokinetic sampling scenarios for the clinical evaluation of a novel oral suspension of spironolactone in pediatric patients with edema. A population pharmacokinetic model was developed and qualified for spironolactone and its metabolite, canrenone, using data from adults and bridged to pediatrics (2 to <17 years old) using allometric scaling. The model was then used via simulation to explore different dosing and sampling scenarios. Doses of 0.5 and 1.5 mg/kg led to target exposures (i.e., similar to 25 and 100 mg of the reference product in adults) in all the reference pediatric ages (i.e., 2, 6, 12 and 17 years). Additionally, two different sampling scenarios were delineated to accommodate patients into sparse sampling schemes informative to characterize drug pharmacokinetics while minimizing phlebotomy and burden to participating children.

Pharmacokinetics and Pharmacodynamics of Intranasal Insulin Administered to Healthy Subjects in Escalating Doses

2005 ◽  
Vol 7 (1) ◽  
pp. 124-130 ◽  
Author(s):  
Andrew C. Leary ◽  
Robert M. Stote ◽  
H.J. Breedt ◽  
Jackie O'brien ◽  
Brendan Buckley
Keyword(s):  
Healthy Subjects ◽  
Intranasal Insulin ◽  
Pharmacokinetics And Pharmacodynamics

scholarly journals Pharmacokinetics and pharmacodynamics of γ-hydroxybutyrate in healthy subjects

2016 ◽  
Vol 81 (5) ◽  
pp. 980-988 ◽  
Author(s):  
Matthias E. Liechti ◽  
Boris B. Quednow ◽  
Evangelia Liakoni ◽  
Dario Dornbierer ◽  
Robin von Rotz ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Pharmacokinetics And Pharmacodynamics
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