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BIOMEDICAL TESTING LABORATORY

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RESEARCH AND DEVELOPMENT INSTITUTE

BIOTECHNOLOGY AND BIOMEDICAL TESTING DEPARTMENT

BIOMEDICAL TESTING LABORATORY

Following the audit performed by the RS Ministry of Health competent auditors, the Biomedical Testing Laboratory was granted a Good Laboratory Practice Certificate on January 12, 2016, in accordance with the Law on Medicines and Medical Devices ("The Official Gazette of the RS” No.30/10).

By obtaining this certificate, the Biomedical Testing Laboratory joined the few laboratories in Serbia and in the Region that perform their activities in compliance with the Good Laboratory Practice principles. In addition to increasing the confidence in the quality of the tests performed, this certificate will also enable the Laboratory to provide non-clinical trial services to third parties. The tests performed at the Biomedical Testing Laboratory include non-clinical trials of medicines, biologically active substances and biocompatibility testing of medical devices for the purpose of new product development, quality control and marketing authorisation of products.



Toxicology tests:

  • Acute, subacute and subchronic systemic toxicity
  • Local tolerance (intramuscular, oral, dermal, vaginal, rectal, ocular, nasal and gingival) li>
  • Test for pyrogens
  • Abnormal toxicity test


Medical device biocompatibility testing:

  • Primary and cumulative skin irritation tests
  • Sensitisation tests
  • Test for local effects following implantation
  • Medical device systemic toxicity testing (acute, subacute, subchronic)


Animal model development

For the purpose of testing efficacy of substances, a number of animal models have been developed and verified, such as: hyperlipidaemia and obesity in rats, subcutaneous mice melanoma, multiple sclerosis models and rat osteoporosis model.




The staff performing the above tasks and activities includes:

four PhDs and two Masters of life and medical sciences, one Doctor of Veterinary Medicine and four technicians with years of professional experience.






 

 

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