Clinical Research Directory

Pharmacometric Modeling of a Hospital Preparation

Sponsor: University Hospital, Rouen

Summary

Pediatric prescribers are very often faced with a lack of suitable therapies, particularly oral ones. This represents a major public health problem and necessitates adjustments to dosage or pharmaceutical form using medications marketed for adults, some of which contain excipients that may be harmful to children. This creates risks of dilution errors, administration errors, and the occurrence of adverse effects. Hospital pharmacy technicians are called upon daily to provide appropriate treatment for children. However, although this activity is authorized (Public Health Code, Good Preparation Practices), pharmacokinetic/pharmacodynamic studies on these preparations are only exceptionally carried out. Indeed, only stability studies are required to determine the expiration date of the preparation. Thus, prescribers are left without the necessary information to choose the dosage and administration schedule. Pediatric dosages are extrapolated from those for adults without any certainty of the treatment's effectiveness.

Official title: Pharmacometric Modeling of a Hospital Preparation of Nicardipine Hydrochloride Oral Solution at 2 mg/mL in Hypertensive Patients in Pediatric Hematology-oncology

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