Author:
Makuch Robert W.,Shi Ruizhi
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Reference32 articles.
1. Marc Desgrousilliers OR. Drug Development Time Is Money for Some Life-and-Death for Others. Sunnyvale, CA: Clinical Data Solution; 2012.
2. Tanimoto T, Tsubokura M, Mori J, Pietrek M, Ono S, Kami M. Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin. Invest New Drugs. 2013;31:473–478.
3. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics: comparison of three regulatory agencies. N Engl J Med. 2012;366:2284–2293.
4. Malinowski HJ, Westelinck A, Sato J, Ong T. Same drug, different dosing: differences in dosing for drugs approved in the United States, Europe, and Japan. J Clin Pharmacol. 2008;48:900–908.
5. FDA. Is it true FDA is approving fewer new drugs lately? https://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM247465.pdf. Accessed January 5, 2013.
Cited by
8 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