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

• Main Authors: Manasa Tatipalli (Author), Vijay Kumar Siripuram (Author), Tao Long (Author), Diana Shuster (Author), Galina Bernstein (Author), Pierre Martineau (Author), Kim A. Cook (Author), Rodrigo Cristofoletti (Author), Stephan Schmidt (Author), Valvanera Vozmediano (Author)
• Format: Book
• Published: MDPI AG, 2021-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 spironolacto...