Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (8): 449-451.

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The Safety Evaluation Study of C ASANT Sustained-release Anti-tumor Agent by Implanted Medication in the Lung of Beagle Dog

TANG Lian -sheng JIA Qing -wen*   

  1. Shandong Institute of Pharmaceutical Industry, Center for Drug Evaluation, Shandong Jinan 250033, China
  • Received:2013-01-18 Revised:2016-03-09 Online:2013-08-08 Published:2016-03-09

Abstract: Objective To evaluate the general toxicity of CASANT sustained-release anti-tumor agent by implanted medication in the lung of Beagle dog. Methods The test substance [1,2,4 mg/dog] was implanted into the lung of Beagle dog by using MyLabTwice ultrasonic diagnostic apparatus to guide positioning. After administration, the ani mals were continuously observed. The body temperature, urine, standard lead-ECG, hematology, serum chemistry indicators were detected, and the bone marrow examination, histological examination of major organs and tissues were conducted at 2,4,8,13 wk. Results There were no statistical significance between the test substance groups and control group in above indexes. The histological examination showed no tissue damage. Conclusion The CASANT does not have toxicity on Beagle dog.

Key words: sustained-release agent, implanted, non-clinical safety

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