title: Safety assessment in pediatric studies.
abstract: It typically takes many years before an association of a drug with a rare, serious adverse reaction is established. As related to pediatric drug use, evidence is even more erratic, as most drugs are used off labels. To enhance child safety, there is an urgent need to develop robust and rapid methods to identify such associations in as timely a manner as possible. In this chapter, several novel methods, both clinically based pharmacoepidemiological approaches and laboratory-based methods, are described.
authors: The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, M5G 1X8, ON, Canada. gidiup_2000@yahoo.com
authors: Gideon
authors: G
authors: Koren
authors: Abdelbasset
authors: A
authors: Elzagallaai
authors: Fatma
authors: F
authors: Etwel
mesh_terms: D000927:Anticonvulsants / Q000009:adverse effects / Q000276:immunology / Q000378:metabolism / Q000494:pharmacology; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D002170:Canada / Q000453:epidemiology; D016923:Cell Death / Q000187:drug effects; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000276:immunology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000276:immunology; D023381:Endpoint Determination / Q000379:methods*; D006801:Humans; D017114:Liver Failure, Acute / Q000139:chemically induced / Q000453:epidemiology; D008213:Lymphocyte Activation / Q000187:drug effects / Q000276:immunology; D008214:Lymphocytes / Q000187:drug effects / Q000276:immunology; D010372:Pediatrics / Q000379:methods*; D010389:Pemoline / Q000009:adverse effects / Q000627:therapeutic use; D017891:Pharmacoepidemiology; D011237:Predictive Value of Tests; D011358:Product Surveillance, Postmarketing; D012306:Risk; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D000927:Anticonvulsants; D010389:Pemoline