ABSTRACT
OBJECTIVE：To provide reference for promoting individualized medication in clinic. METHODS ：Information on external quality assessment （EQA）projects and approved kits for the guidance of chemical drug use were collected from the websites of National Center for Clinical Laboratories （NCCL） and National Medical Products Administration （NMPA） as of December 31，2019. The number of laboratories participating in each evaluation project was count. Taking EQA projects of clopidogrel and warfarin drug metabolism gene polymorphism detection as examples ，who was with the highest participation rate ， the methods and reagent kits of each laboratory were analyzed so as to analyze the current status of the clinical pharmacogenomics （PGx）in China. RESULTS ：The number of PGx genetic test EQA projects conducted by NCCL increased from 3（2014）to 9 （2019）. The total number of participating laboratories was 926 in 2018，and 1 249 in 2019. The number of laboratories of warfarin and clopidogrel drug metabolism gene polymorphism detection increased from 57 to 300.5 for warfarin and from 124 to 374.5 for clopidogrel. The more widely used methods were fluorescent PCR and PCR-chip hybridization. The number of reagent kits currently approved by NMPA was 7 for warfarin and 15 for clopidogrel ，respectively. But some of the laboratories participating in EQA used self-prepared reagents yet. CONCLUSIONS ：The clinical PGx is in its infancy ，and the awareness of laboratories about EQA is improving；the main method was fluorescence PCR ，but the use of self-made reagents in laboratories is still common ，regulations concerning the approval ，use and supervision still need to be further improved.
ABSTRACT
Hot melt extrusion (HME) is an effective method to make the drugs form amorphous solid dispersions (ASD) in microstructure, through which we can improve the dissolution behavior so as to improve the bioavailability of hydrophobic drugs. This review mainly focuses on the screening of active pharmaceutical ingredients and polymer carriers, feasibility evaluation of the technique, and the control of key parameters of preparation process, summarizes the application of HME to develop drug delivery system.