Pharmacological and safety aspects of existing requirements and regulations when introducing a new drug.
作者信息
Kramer M
出版信息
Arzneimittelforschung. 1974 Apr;24(4):504-8.
PMID:4408328
Abstract
摘要
相似文献
1
Pharmacological and safety aspects of existing requirements and regulations when introducing a new drug.引入新药时现有要求和法规的药理学及安全性方面。
Arzneimittelforschung. 1974 Apr;24(4):504-8.
2
[Bioavailability, proof of efficacy and their consequences for drug legislation (author's transl)].[生物利用度、疗效证明及其对药品立法的影响（作者译）]
Arzneimittelforschung. 1976;26(1A):158-63.
3
The Food and Drug Administration's requirements for approval of new dental drugs.
Symp Pharmacol Ther Toxicol Group. 1975 Apr 6:5-12.
4
Towards a more rational regulation of the development of new medicines. Report of a European workshop held in Sestri Levante, Italy, September 28-30, 1976.
Eur J Clin Pharmacol. 1977 Mar 11;11(3):233-8.
5
Food and Drug Administration regulations and licensure.食品药品监督管理局的规定与许可
Fed Proc. 1975 May;34(6):1522-4.
6
Institute of Medicine's new drug safety report: implications for Canada.美国医学研究所的新药安全报告：对加拿大的影响。
CMAJ. 2006 Dec 5;175(12):1515-6. doi: 10.1503/cmaj.061437.
7
[Metabolism of drugs and drug security].
Dtsch Med Wochenschr. 1975 Oct 31;100(44):2285-92. doi: 10.1055/s-0028-1106537.
8
Current status of international drug regulation.
Med Mark Media. 1978 Feb;13(2):37-8, 40, 42-5.
9
Response to the applicability of proposed large volume parenteral regulations to small volume parenteral drug products.对拟议的大容量注射剂法规适用于小容量注射剂药品的回应。
Bull Parenter Drug Assoc. 1976 Nov-Dec;30(6):265-79.
10
The control of drugs and therapeutic freedom.药物管制与治疗自由
Proc R Soc Med. 1968 Aug;61(8):841-6. doi: 10.1177/003591576806100840.
Zotero 插件