Pediatric Patient Considerations During Dose Development

Pediatric clinical trials are becoming more prevalent and are now typically mandatory within clinical development plans. However, pediatric populations present significant development challenges related to dose form design. The absence of an available pediatric dosage forms can lead to increased potential for dosing errors or nonadherence. Therefore, specific dosing guidelines and acceptable dosage forms for pediatric patients need to be developed to optimize therapeutic efficacy and limit and prevent serious adverse side effects.