DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE
The danger of animal complications due to drug therapy increases the responsibility of developers/manufacturers for the safety of medicinal products for veterinary use, including those in civilian circulation. At the time of making a decision on the state registration of a drug, information obtained...
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| Format: | Article |
| Language: | Russian |
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Federal Scientific Centre VIEV
2019-09-01
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| Series: | Российский паразитологический журнал |
| Subjects: | |
| Online Access: | https://vniigis.elpub.ru/jour/article/view/371 |
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| author | N. P. Biryukova V. V. Napalkova A. V. Morozova |
| author_facet | N. P. Biryukova V. V. Napalkova A. V. Morozova |
| author_sort | N. P. Biryukova |
| collection | DOAJ |
| description | The danger of animal complications due to drug therapy increases the responsibility of developers/manufacturers for the safety of medicinal products for veterinary use, including those in civilian circulation. At the time of making a decision on the state registration of a drug, information obtained during its preclinical and clinical studies on undesirable reactions and side effects cannot be complete, since these studies are limited to a small number and similarity of experimental animals and a relatively short duration of experiments. In addition, with long-term use of the drug may be delayed adverse side reactions that can occur months and years after exposure of the drug to a living organism. Considering this, the pharmacovigilance system should function effectively in the producer (or developer) of the drug, the main task of which is monitoring monitoring of drug safety during the pre-registration period, tracking and analyzing data on the effect of the drug when it is in public circulation, and taking adequate measures to prevent adverse effects of drug therapy. As a result of the analysis, data on regulatory and methodological documents on the organization of monitoring the safety of pharmacological drugs were systematized, recommendations prepared with the provisions of international and domestic legislative regulatory and information documents related to the methodology of organizing pharmacovigilance and monitoring drug safety were prepared. |
| format | Article |
| id | doaj-art-bf38f54a8bf04b0ab65a1b08049e9b61 |
| institution | Matheson Library |
| issn | 1998-8435 2541-7843 |
| language | Russian |
| publishDate | 2019-09-01 |
| publisher | Federal Scientific Centre VIEV |
| record_format | Article |
| series | Российский паразитологический журнал |
| spelling | doaj-art-bf38f54a8bf04b0ab65a1b08049e9b612025-08-03T19:18:30ZrusFederal Scientific Centre VIEVРоссийский паразитологический журнал1998-84352541-78432019-09-01132738110.31016/1998-8435-2019-13-2-73-81368DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USEN. P. Biryukova0V. V. Napalkova1A. V. Morozova2All-Russian State Center for Quality and Standardization of Medicines for Animals and FeedAll-Russian State Center for Quality and Standardization of Medicines for Animals and FeedAll-Russian State Center for Quality and Standardization of Medicines for Animals and FeedThe danger of animal complications due to drug therapy increases the responsibility of developers/manufacturers for the safety of medicinal products for veterinary use, including those in civilian circulation. At the time of making a decision on the state registration of a drug, information obtained during its preclinical and clinical studies on undesirable reactions and side effects cannot be complete, since these studies are limited to a small number and similarity of experimental animals and a relatively short duration of experiments. In addition, with long-term use of the drug may be delayed adverse side reactions that can occur months and years after exposure of the drug to a living organism. Considering this, the pharmacovigilance system should function effectively in the producer (or developer) of the drug, the main task of which is monitoring monitoring of drug safety during the pre-registration period, tracking and analyzing data on the effect of the drug when it is in public circulation, and taking adequate measures to prevent adverse effects of drug therapy. As a result of the analysis, data on regulatory and methodological documents on the organization of monitoring the safety of pharmacological drugs were systematized, recommendations prepared with the provisions of international and domestic legislative regulatory and information documents related to the methodology of organizing pharmacovigilance and monitoring drug safety were prepared.https://vniigis.elpub.ru/jour/article/view/371monitoring studies of drug safetypharmacovigilancepost-registration studiesadverse reactionsside effects |
| spellingShingle | N. P. Biryukova V. V. Napalkova A. V. Morozova DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE Российский паразитологический журнал monitoring studies of drug safety pharmacovigilance post-registration studies adverse reactions side effects |
| title | DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE |
| title_full | DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE |
| title_fullStr | DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE |
| title_full_unstemmed | DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE |
| title_short | DRUG SAFETY MONITORING SERVICE IN DEVELOPING ORGANIZATIONS / MANUFACTURERS OF DRUGS FOR VETERINARY USE |
| title_sort | drug safety monitoring service in developing organizations manufacturers of drugs for veterinary use |
| topic | monitoring studies of drug safety pharmacovigilance post-registration studies adverse reactions side effects |
| url | https://vniigis.elpub.ru/jour/article/view/371 |
| work_keys_str_mv | AT npbiryukova drugsafetymonitoringserviceindevelopingorganizationsmanufacturersofdrugsforveterinaryuse AT vvnapalkova drugsafetymonitoringserviceindevelopingorganizationsmanufacturersofdrugsforveterinaryuse AT avmorozova drugsafetymonitoringserviceindevelopingorganizationsmanufacturersofdrugsforveterinaryuse |