Author:
Cutroneo Paola M.,Isgrò Valentina,Russo Alessandra,Ientile Valentina,Sottosanti Laura,Pimpinella Giuseppe,Conforti Anita,Moretti Ugo,Caputi Achille P.,Trifirò Gianluca
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Toxicology
Reference22 articles.
1. Coordination Group for Mutual Recognition and Decentralised Procedures. Questions & answers biologicals. CMDh/269/2012, October 2012. http://www.hma.eu . Accessed 30 July 2014.
2. European Medicinal Agency. Questions and answers on biosimilar medicines (similar biological medicinal products) 2012. EMA/837805/2011. http://www.ema.europa.eu . Accessed 30 July 2014.
3. Giezen TJ, Mantel-Teeuwisse AK, Leufkens HGM. Pharmacovigilance of biopharmaceuticals. Drug Saf. 2009;32(10):811–7.
4. Giezen TJ, Mantel-Teeuwisse AK, Straus SMJM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA. 2008;300(16):1887–96.
5. European Medicines Agency, Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP)—module VI 2012. EMA/873138/2011. http://www.ema.europa.eu . Accessed 30 July 2014.
Cited by
36 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献