کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
946540 926197 2007 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Clinical Development of Antiepileptic Drugs for Children
موضوعات مرتبط
علوم زیستی و بیوفناوری علم عصب شناسی عصب شناسی
پیش نمایش صفحه اول مقاله
Clinical Development of Antiepileptic Drugs for Children
چکیده انگلیسی
A clinical development plan specific to children is a necessary component of every development plan for a new antiepileptic drug (AED). In the last decade, considerable discussion has occurred in the medical and regulatory communities, resulting in specific pediatric drug development legislation. Ethical issues are a foremost consideration in the design and conduct of studies. The timing of clinical studies differs between adults and children. In general, studies in children will not be performed until efficacy and safety has been demonstrated in adults. Exceptions include development of AEDs for seizure types seen only in children. Formulation preparation and dosing selection are often more challenging in children. Clinical trials including pharmacokinetic studies will be conducted in patients. A relatively small number of children, given subdivision into age groups and seizure types, are available for study. Clinical trials must be designed with children in mind, adjusting the length of the trials and the choice of controls. Efficacy extrapolation from adults may be considered for partial seizures in children, but not in infants. Seizure counts remain an appropriate efficacy endpoint; however, ascertainment in infants and younger children may require EEG monitoring. Safety specific to growing and developing children must be evaluated and long-term effects monitored.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Neurotherapeutics - Volume 4, Issue 1, January 2007, Pages 70-74
نویسندگان
,