| ABSTRACIn recent years，biologicals were playing an increasingly indispensable role in medical field with the rapid development. Compared to small molecules, biologicals had some different physicochemical properties including large molecular weight, complex structure and the different structure determines the different function. The safety, efficacy and stability of the biological had certain special risks may be associated with the production process, storage and transportation conditions and clinical application. This paper fully reviewed the drug risk and risk management of biological in the production, storage, transportation and clinical application. |
