General consideration of non-clinical evaluation for anti-tumor biologic products
WANG Hai-xue
WANG Qing-lin
PENG Jian
Abstract：Non-clinical evaluation for biologic products is widely different from conventional chemical prod-ucts. Since it is hard to confirm its structure,immunogenicity,the possible pollution in produce process,biologic products should assure the quality properties in safety,identification,purification,efficacy for pharmacy areas,then move to non-clinical tests based on rational animal models,including pharmacology,toxicology,and pharmacokinet-ics study. In non-clinical process,it is important to consider the bioactivities,immunogenicity/immunotoxicity and the disposal process in vivo. It would be so prudential when the non-clinical results were used to predict human study.
Keywords：antitumor drugbiologic productsnonclinicalevaluation
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2210-2214 )