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Article in Russian | MEDLINE | ID: mdl-27228672

ABSTRACT

AIM: Determination of values of coefficients of thermal stability of TEOVac for prognosis of conservation of the vaccine (specific biological activity) during the process of warranty period storage. MATERIALS AND METHOD: TEOVac (masticatory tablets) in primary packaging was kept at increased temperature (accelerated and stress-tests) and at the conditions established by PAP for the preparation (long-term tests). Biological activity of the vaccine was determined by titration on 12-day chicken embryos. RESULTS: A correlation between the value of coefficients of thermal stability and conservation of the prepared series of the condition preparation at the final date of storage was experimentally established. CONCLUSION: Coefficients of thermal stability could be used as a prognostic indicator of quality of the produced pelleted formulation of the preparation for evaluation of conservation of the vaccine during warranty period storage.


Subject(s)
Smallpox Vaccine/metabolism , Smallpox/prevention & control , Vaccines, Attenuated/metabolism , Animals , Chemistry, Pharmaceutical , Chick Embryo , Chickens , Humans , Smallpox/virology , Smallpox Vaccine/therapeutic use , Temperature , Vaccines, Attenuated/therapeutic use
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