The STEP (Safety and Toxicity of Excipients for Paediatrics) database: Part 2 – The pilot version

Allegaert, 2010, Prospective assessment of short-term propylene glycol tolerance in neonates, Arch. Dis. Child., 95, 1054, 10.1136/adc.2010.190330 Balistreri, 1986, Lessons from the E-Ferol tragedy, Pediatrics, 78, 503, 10.1542/peds.78.3.503 Brandys, 2012, The STEP (Safety and Toxicity of Excipients for Paediatrics) Database Carter, 2011, Risk assessment for excipients for enhanced patient safety, Pharm. Technol., 35, 29 CHMP, 2006 Crump, 2010, The future use of in vitro data in risk assessment to set human exposure standards: challenging problems and familiar solutions, Environ. Health Perspect., 118, 1350, 10.1289/ehp.1001931 EMA, 2001 Ernest, 2007, Developing paediatric medicines: identifying the needs and recognizing the challenges, J. Pharm. Pharmacol., 59, 1043, 10.1211/jpp.59.8.0001 Fabiano, 2011, Paediatric pharmacology: remember the excipients, Pharmacol. Res., 63, 362, 10.1016/j.phrs.2011.01.006 FDA, 2011 Frazier, 1992 Guengerich, 2007, Applying mechanisms of chemical toxicity to predict drug safety, Chem. Res. Toxicol., 20, 344, 10.1021/tx600260a Judson, 2009, The toxicity data landscape for environmental chemicals, Environ. Health Perspect., 117, 685, 10.1289/ehp.0800168 Kulo, 2012, The propylene glycol research project to illustrate the feasibility and difficulties to study toxicokinetics in neonates, Int. J. Pharm., 435, 112, 10.1016/j.ijpharm.2012.05.014 Lass, 2012, Hospitalised neonates in Estonia commonly receive potentially harmful excipients, BMC Pediatr., 12, 136, 10.1186/1471-2431-12-136 Maldonado, 2011, Pediatric formulations, Am. Pharm. Rev. Nunn, 2005, Formulation of medicines for children, Br. J. Clin. Pharmacol., 59, 674, 10.1111/j.1365-2125.2005.02410.x Rowe, 2012 Shehab, 2009, Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates, Pediatr. Crit. Care Med., 10, 256, 10.1097/PCC.0b013e31819a383c Salunke, 2010, Pilot database addressing safety and toxicity aspects of excipients for paediatric medicines development Salunke, 2012, The STEP (Safety and Toxicity of Excipients for Paediatrics) database. Part 1—A need assessment study, Int. J. Pharm., 435, 101, 10.1016/j.ijpharm.2012.05.004 Vaconsin, 2012, ESNEE project: strategy for the extensive review of the literature on excipient toxicities, Eur. J. Hosp. Pharm.: Sci. Pract., 19, 183, 10.1136/ejhpharm-2012-000074.259 Vaconsin, 2013, GRP-001 1St ESNEE Excipient Monograph: information needed to formulate, prepare and prescribe medicines for neonates containing propylene glycol as an excipient, Eur. J. Hosp. Pharm.: Sci. Pract., 20, A1, 10.1136/ejhpharm-2013-000276.001 Tomasulo, 2002, ChemIDplus – super source for chemical and drug information, Med. Ref. Serv. Q., 21, 53, 10.1300/J115v21n01_04 Turner, 2012, European Study for Neonatal Excipient Exposure (ESNEE), Eur. J. Hosp. Pharm.: Sci. Pract., 19, 67, 10.1136/ejhpharm-2012-000065 Ursino, 2011, Excipients in medicinal products used in gastroenterology as a possible cause of side effects, Regul. Toxicol. Pharmacol., 60, 93, 10.1016/j.yrtph.2011.02.010 WHO, 1987, Principles for the safety assessment of food additives and contaminants in food