The Target Animal Safety Test—Is it Still Relevant?

Biologicals ◽  
2002 ◽  
Vol 30 (4) ◽  
pp. 277-287
2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
L. DeTolla ◽  
R. Sanchez ◽  
E. Khan ◽  
B. Tyler ◽  
M. Guarnieri

Subcutaneous drug implants are convenient systems for the long-term delivery of drugs in animals. Lipid carriers are logical tools because they generally allow for higher doses and low toxicity. The present study used an US Food and Drug Administration Target Animal Safety test system to evaluate the safety of a subcutaneous implant of a cholesterol-triglyceride-buprenorphine powder in 120 BALB/c mice. Mice were evaluated in 4- and 12-day trials with 1- and 5-fold doses of the intended 3 mg/kg dose of drug. One male mouse treated with three 3 mg/kg doses and surgery on days 0, 4, and 8 died on day 9. The cause of death was not determined. In the surviving 119 mice there was no evidence of skin reaction at the site of the implant. Compared to control animals treated with saline, weight measurements, clinical pathology, histopathology, and clinical observations were unremarkable. These results demonstrate that the lipid carrier is substantially safe. Cholesterol-triglyceride-drug powders may provide a valuable research tool for studies of analgesic and inflammatory drug implants in veterinary medicine.


2017 ◽  
Vol 08 (06) ◽  
Author(s):  
David Xiang Yu ◽  
Zhiyong He ◽  
Colin Pouton ◽  
Frederic J Hoerr ◽  
Zhi cheng Xiao

2018 ◽  
Vol 117 ◽  
pp. 246-254 ◽  
Author(s):  
S.Y. Broeckx ◽  
J.H. Spaas ◽  
K. Chiers ◽  
L. Duchateau ◽  
L. Van Hecke ◽  
...  

2019 ◽  
Vol 103 ◽  
pp. 21-33
Author(s):  
Zhen Dong ◽  
Jichao Sun ◽  
Yubin Bai ◽  
Weiwei Wang ◽  
Yueming Zhu ◽  
...  

Author(s):  
Article Editorial

Neugodova N.P., Stepanyuk E.O., Sapozhnikova G.A., Sakanyan E.I., Ryabtseva M.S. Current approaches to the abnormal toxicity test. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya = The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2020;10(2):82–88. https://doi.org/10.30895/1991-2919-2020-10-2-82-88Dear readers, on page 84 (second paragraph from the bottom, left column) in issue 2 of The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products, 2020 (2020;10(2):82–88) the following statement: “The discussions centered around suppression of the abnormal toxicity test and target animal batch safety test for vaccines for human use, and the possibility of suppression of the laboratory animal batch safety test for veterinary vaccines” should read: “The discussions centered around suppression of the abnormal toxicity test for vaccines for human use, and the possibility of suppression of the laboratory animal batch safety test and target animal batch safety test for veterinary vaccines”. 


Lab Animal ◽  
2015 ◽  
Vol 45 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Alan Cowan ◽  
Rachel Sarabia-Estrada ◽  
Gina Wilkerson ◽  
Patrick McKnight ◽  
Michael Guarnieri

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