An overview of the definition, the strengths and the limitations of bioassays in the quality control is made and the trend of their replacement by physical and chemical methods through a comparison of ChP and other countries’pharmacopeia is analyzed. Ideas and references of the establishment and the validation of the alternative methods are provided for different sorts of biochemical drugs. The review also summarizes the most common experimental design and two statistical analysis methods. At last, the importance of the combination and the promotion of different quality control modes is emphasized.
LI Zhen
,
ZHANG Yuan
,
GAO Hua
. Bioassays of biochemical drugs and their alternatives[J]. Science & Technology Review, 2017
, 35(13)
: 66
-69
.
DOI: 10.3981/j.issn.1000-7857.2017.11.010
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