TY - JOUR AU - U.S. Department of Health and Human Services Food and Drug Administration AU - Center for Drug Evaluation and Research (CDER) AU - Center for Biologics Evaluation and Research (CBER) KW - Safety Reporting Requirements for INDs and BA/BE Studies PY - 2012 TI - Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies UR - http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmorhttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm ER - TY - JOUR AB - Background More than 30 percent of patients with epilepsy have inadequate control of seizures with drug therapy, but why this happens and whether it can be predicted are unknown. We studied the res... AU - Atrick, P AU - Wan, K AU - Artin, M AU - Rodie, J B DA - 2009/8// DO - 10.1056/NEJM200002033420503 IS - 5 PB - Massachusetts Medical Society PY - 2009 SP - 314 EP - 319 TI - Early Identification of Refractory Epilepsy T2 - http://dx.doi.org/10.1056/NEJM200002033420503 UR - https://www.nejm.org/doi/full/10.1056/nejm200002033420503 VL - 342 ER -