Author(s): LI Zhan-jun, LIANG Cheng-gang, YANG Hua-xin, National Institutes for Food and Drug Control
Pages: 1524-1529
Year: 2014 Issue:  9
Journal: Chinese Journal of Pharmaceutical Analysis
Keyword:  rhFSH; in vivo bioassay; physicochemical methods; substitution; specific activity; batch-to-batch consistency;
Abstract: Limitations and role of the bioassay for recombinant human folliclestimulating hormone( rhFSH) were reviewed. It is clarified that the physicochemical determination will substitute the potency determination for rhFSH preparations which have long term batchtobatch consistency while bioassay would still be chosen in the research and development stage.