兽药的生物等效度
摘要
在介绍生物等效度概念基础上 ,对生物等效度的适用范围、生物影响因素、试验方法选择和生物等效度与残留的关系等做了较为详尽的说明 ,可供我国兽药的研制开发。
出处
《中国兽药杂志》
2002年第3期47-50,共4页
Chinese Journal of Veterinary Drug
参考文献7
-
1[1]Toutain P-L, Koritz GD. Veterinary drug bioequivalence determination[J]. Journal of Veterinary Pharmacology and Therapeutics 1997; 20: 79-90.
-
2[2]European Commission. Conduct of bioequivalence studies in animals[R]. In The Rules Governing Medicinal Products in the European Union. Vol.7. Guidelines for the testing of veterinary medicinal products. 37-46.
-
3[3]CVM-FDA. Bioequivalence Guideline[S]. 1996; 1-26.
-
4[4]Steinijans VW, Hauschke D. International harmonization of regulatory bioequivalence requirements[J]. Clinical Research and Regulatory Affairs 1993; 10: 203-220.
-
5[5]Skelly JP, Van Buskirk GA, Savello DR, et al. Workshop report: scale-up of immediate release oral solid dosage forms[J]. European J Pharmacology and Biopharmacy 1992; 38: 213-216.
-
6[6]Blume H, McGilveray IJ, Midha KK. Bio-international 94' conference on bioavailability, bioequivalence and pharmacokinetic studies and pre-conference satellite on "in vivo/in vitro correction"[J]. European J Drug Metab Pharmacok. 1995; 20: 3-13.
-
7[7]Koritz GD. Human food safety: Human food safety considerations[J]. Journal of Veterinary Pharmacology and Therapeutics 1994; 17: 113-115.