Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN")
Relevance. Interpretation of the preclinical trials data is fundamental importance. The correctness of extrapolation of data obtained from animals to humans is due to the qualitative and quantitative diversity of the systems tested the recorded parameters and approaches to their interpretation, as w...
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| Format: | Article |
| Language: | Russian |
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LLC “Publisher OKI”
2022-12-01
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| Series: | Фармакокинетика и Фармакодинамика |
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| Online Access: | https://www.pharmacokinetica.ru/jour/article/view/333 |
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| author | V. B. Vasilyuk M. V. Faraponova G. I. Syraeva A. B. Verveda A. V. Belskaya A. V. Shults L. G. Kubarskaya E. A. Zolotoverkhaya |
| author_facet | V. B. Vasilyuk M. V. Faraponova G. I. Syraeva A. B. Verveda A. V. Belskaya A. V. Shults L. G. Kubarskaya E. A. Zolotoverkhaya |
| author_sort | V. B. Vasilyuk |
| collection | DOAJ |
| description | Relevance. Interpretation of the preclinical trials data is fundamental importance. The correctness of extrapolation of data obtained from animals to humans is due to the qualitative and quantitative diversity of the systems tested the recorded parameters and approaches to their interpretation, as well as statistical methods in determining the possible risk to humans. Aim. Comparative assessment of the safety and tolerability parameters obtained during the preclinical and clinical trials of the Reamberin® (LLC «POLYSAN») and the development of approaches to improving clinical trial planning processes for assessing safety and tolerability, taking into accounts the results of preclinical studies. Materials and methods. A comparative analysis of the safety parameters that arose during a clinical study involving healthy volunteers and deviations from the control levels of clinical and laboratory parameters established at the stage of a preclinical study on outbred rats and rabbits of the chinchilla breed of a drug with an international non-proprietary name (INN): meglumine sodium succinate (trade name (TN) Reamberin® (LLC «POLYSAN»)). Results. Unidirectional deviations from normal (control) values were established. Isolated cases of adverse events among healthy volunteers (increased activity of hepatic transaminases, changes in blood pressure) were identified. This facts didn't correlate with the preclinical study. The number of comparable indicators in laboratory animals, for which statistically significant differences were established between the experimental and control groups, significantly exceeded the number of signs in the form of adverse events among healthy volunteers. |
| format | Article |
| id | doaj-art-ccade6beb18f43569656c6d7dd4642d8 |
| institution | Kabale University |
| issn | 2587-7836 2686-8830 |
| language | Russian |
| publishDate | 2022-12-01 |
| publisher | LLC “Publisher OKI” |
| record_format | Article |
| series | Фармакокинетика и Фармакодинамика |
| spelling | doaj-art-ccade6beb18f43569656c6d7dd4642d82025-08-20T03:42:30ZrusLLC “Publisher OKI”Фармакокинетика и Фармакодинамика2587-78362686-88302022-12-0103526110.37489/2587-7836-2022-3-52-61312Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN")V. B. Vasilyuk0M. V. Faraponova1G. I. Syraeva2A. B. Verveda3A. V. Belskaya4A. V. Shults5L. G. Kubarskaya6E. A. Zolotoverkhaya7Limited Liability Company «Research Center Eco-safety»; North-Western State Medical University named I. I. MechnikovLimited Liability Company «Research Center Eco-safety»Limited Liability Company «Research Center Eco-safety»; FSBEI HE “Academician I. P. Pavlov First St. Petersburg State Medical University” of the Ministry of Healthcare of Russian FederationLimited Liability Company «Research Center Eco-safety»; Scientific and clinical center of toxicology named after academician S.N. Golikov Federal Medical and Biological AgencyScientific and clinical center of toxicology named after academician S.N. Golikov Federal Medical and Biological AgencyScientific and clinical center of toxicology named after academician S.N. Golikov Federal Medical and Biological AgencyScientific and clinical center of toxicology named after academician S.N. Golikov Federal Medical and Biological AgencyScientific and clinical center of toxicology named after academician S.N. Golikov Federal Medical and Biological AgencyRelevance. Interpretation of the preclinical trials data is fundamental importance. The correctness of extrapolation of data obtained from animals to humans is due to the qualitative and quantitative diversity of the systems tested the recorded parameters and approaches to their interpretation, as well as statistical methods in determining the possible risk to humans. Aim. Comparative assessment of the safety and tolerability parameters obtained during the preclinical and clinical trials of the Reamberin® (LLC «POLYSAN») and the development of approaches to improving clinical trial planning processes for assessing safety and tolerability, taking into accounts the results of preclinical studies. Materials and methods. A comparative analysis of the safety parameters that arose during a clinical study involving healthy volunteers and deviations from the control levels of clinical and laboratory parameters established at the stage of a preclinical study on outbred rats and rabbits of the chinchilla breed of a drug with an international non-proprietary name (INN): meglumine sodium succinate (trade name (TN) Reamberin® (LLC «POLYSAN»)). Results. Unidirectional deviations from normal (control) values were established. Isolated cases of adverse events among healthy volunteers (increased activity of hepatic transaminases, changes in blood pressure) were identified. This facts didn't correlate with the preclinical study. The number of comparable indicators in laboratory animals, for which statistically significant differences were established between the experimental and control groups, significantly exceeded the number of signs in the form of adverse events among healthy volunteers.https://www.pharmacokinetica.ru/jour/article/view/333reamberin®planningsafetyvolunteersratsrabbits |
| spellingShingle | V. B. Vasilyuk M. V. Faraponova G. I. Syraeva A. B. Verveda A. V. Belskaya A. V. Shults L. G. Kubarskaya E. A. Zolotoverkhaya Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN") Фармакокинетика и Фармакодинамика reamberin® planning safety volunteers rats rabbits |
| title | Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN") |
| title_full | Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN") |
| title_fullStr | Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN") |
| title_full_unstemmed | Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN") |
| title_short | Comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the Reamberin® (LLC "POLYSAN") |
| title_sort | comparative evaluation of safety parameters at the preclinical and clinical stages of the study of the reamberin r llc polysan |
| topic | reamberin® planning safety volunteers rats rabbits |
| url | https://www.pharmacokinetica.ru/jour/article/view/333 |
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