title: Obtaining pediatric indications for new anti-epileptic drugs: how and when.
abstract: Drug development in children poses a number of challenges that must be overcome to obtain adequate information in product labeling. Trials in children must be supported by appropriate toxicology and formulation work, which tends to delay completion of work in children until after the drug is available for adults. The Pediatric Research Equity Act (PREA) contains a decision tree to help companies devise an appropriate pediatric program for drugs in development. The medical community does not currently endorse the assumption that the progression of epilepsy and response to treatment is the same in adults and children. Therefore, a complete drug development program in children is necessary and includes efficacy and safety trials along with pharmacokinetic studies. These studies are needed to justify the risk/benefit in children. Formulations appropriate for children are needed. Seizure diaries must be maintained by caretakers and in the case of infants, seizures may need to be counted by EEG. Early planning and discussion of a pediatric program with regulatory agencies will facilitate this work.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Garofalo
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D003663:Decision Trees; D004341:Drug Evaluation / Q000941:ethics / Q000331:legislation & jurisprudence; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D014481:United States
chemical_list: D000927:Anticonvulsants