生物活性检测方法的全生命周期研究是药理学的重要内容,广泛应于药品的活性测定、新药研究以及激素、神经介质等的生理活性测定等领域,对某些药品尤其是生化类药品、生物制品等的检测仍起着无法替代的作用。生物活性检测方法由于使用生物受试体(变异大)、影响因素多,且涉及较多的数理统计内容,因而此类方法涉及的专业术语也较多,在理解和使用当中容易产生混淆。而对术语的正确理解是从事生物活性检测方法相关研究工作的根本基础,因此,本文针对生物活性检测方法中部分常用的关键术语,如方法适用性、重复、平行性等进行初步汇总和深入解析,以期对相关从业人员开展生物活性检测方法评估和应用工作有所助益。
The whole life cycle study of bioassay is an important content of pharmacology. It is widely used in the fields of drug activity determination, new drug research and physiological activity determination of hormones and neurotransmitters. It still plays an irreplaceable role in the determination of some drugs, especially biochemical drugs. Bioassay is different from other physical and chemical determination methods because of its own characteristics and complicated analysis of statistics. Therefore, this kind of method involves more professional terms, which is prone to be confused in understanding and use. The correct understanding of terms is the fundamental basis for the research work related to bioassay. Therefore, this paper makes a preliminary summary and analysis of some key terms in bioassay (eg. method suitability, replicate, parallelism), in order to be helpful for relevant analysts to carry out bioassay.
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