Stainer D W
Stainer Associates, Richmond Hill, Ontario, Canada.
Dev Biol Stand. 1996;86:303-8.
The aim of potency testing is to ensure that vaccines under test will provide protection when used in human subjects. To achieve this, many potency tests for diphtheria and tetanus toxoids have been devised. the potency tests listed in the European Pharmacopoeia and the W.H.O. Requirements call for the use of large numbers of either guinea pigs or mice. These quantal assays are extremely expensive to perform and alternative, more economic methods are clearly needed. The results presented here illustrate that, provided certain rules are followed single point assays can provide the same degree of assurance of potency as the three-point assays currently in use.
效价检测的目的是确保受试疫苗用于人体时能提供保护。为实现这一目标，已设计出许多针对白喉和破伤风类毒素的效价检测方法。《欧洲药典》和世界卫生组织要求中列出的效价检测需要使用大量豚鼠或小鼠。这些定量分析实施起来极其昂贵，显然需要更经济的替代方法。此处给出的结果表明，只要遵循某些规则，单点分析就能提供与目前使用的三点分析相同程度的效价保证。
