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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2008, Vol. 13 ›› Issue (9): 1024-1028.

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Several experimental designs for evaluating the bioactivity of low-molecular-weight heparin

ZHAO Hui-ling   

  1. Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China
  • Received:2008-03-26 Revised:2008-08-12 Online:2008-09-26 Published:2020-10-13

Abstract: AIM: To compare several experimental designs for detecting the bioactivity of low-molecularweight heparin (LMWH).METHODS: Chromogenic assay was used for detecting the bio-activity of LMWH by comparing the 4°4 method to 4°3, 3°4 or 3°3 method in quantity response parallel line design.RESULTS: In bioassay of LMWH with the quantity response parallel line analysis, there had no statistical difference (P>0.05) between 4°4 method with 4°3, 3°4 or 3°3 method.CONCLUSION: Quantity response parallel line design could be used in validation of the chromogenic assays for the potency assessment of LMWH.In parallel line design, 4°4, 4°3, 3°4 or 3°3 method of different dose groups all could be used according to the standard for LMWH.

Key words: LMWH, experimentaldesign, biostatistics, bioassay

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