Non-Clinical Safety Study's Role on Safety Reassessment of Post-Marketing Traditional Chinese Medicine

Abstract

Abstract: It was discussed that non-clinical safety study's role on safety reassessment of post -marketing Traditional Chinese Medicine(TCM) from aspects of toxic connotation, aim and effect of non-clinical safety study. It was proved by experience and fact that non-clinical safety study could provided referential testing data for clinical use, prompted the risk, weighed the advantage and disadvantage of drug and remedied the deficiency of clinical safety study, non-clinical safety study could gradually deepened and enriched safety evaluation and provided basic study support for new ADRs of post-marketing TCM as well. So it was strongly recommended that non-clinical safety study could played an considerable and indispensable role.

Key words: Traditional Chinese Medicine(TCM), non-clinical safety study, safety reassessment of post-marketing drug, adverse drug reaction(ADR)

CLC Number:

R954
R944.11

SONG Jun, ZHAO Jun-ning ,WU Cheng-yun ,ZHOU Ya-li. Non-Clinical Safety Study's Role on Safety Reassessment of Post-Marketing Traditional Chinese Medicine [J]. Chinese Journal of Pharmacovigilance, 2010, 7(12): 730-732.

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