The Use of Modeling and Simulation to Guide Clinical Development of Olmesartan Medoxomil in Pediatric Subjects
| Autor: | D R Wada, Timothy J. Carrothers, Daniel E. Salazar, J Shi, Shashank Rohatagi, SaeHeum Song, Reinilde Heyrman |
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| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
Adolescent Urology Tetrazoles Blood Pressure Body weight Pharmacokinetics medicine Humans Computer Simulation Pharmacology (medical) Dosing Child Antihypertensive Agents Pharmacology Models Statistical Olmesartan Medoxomil Clinical Trials Phase I as Topic Dose-Response Relationship Drug Adult patients business.industry Imidazoles Infant Surgery Clinical trial Blood pressure Clinical Trials Phase III as Topic Child Preschool Hypertension Olmesartan business medicine.drug Pediatric population |
| Zdroj: | Clinical Pharmacology & Therapeutics. 91:250-256 |
| ISSN: | 1532-6535 0009-9236 |
| DOI: | 10.1038/clpt.2011.220 |
| Popis: | Modeling and simulation were used extensively in the development of an indication for the use of olmesartan medoxomil in pediatric patients with hypertension. Simulations based on models developed in adult patients indicated that two dose groups were sufficient to estimate a dose-response relationship, thereby reducing by one-third the number of subjects required for the phase III pediatric study. Model-based predictions for blood pressure reduction agreed with the observed results of the subsequent phase III study, showing statistically significant dose-response relationships with respect to both systolic and diastolic blood pressure. Previously established pharmacokinetic and exposure-response relationships in adults, adjusted for the influence of body weight on clearance (wt(0.80)), were confirmed in the pediatric population. Together, these findings support an olmesartan dosing recommendation in pediatric subjects aged 6 to 16 years of 10 mg for subjects weighing |
| Databáze: | OpenAIRE |
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