Modern approaches to the assessment of orally inhaled products bioequivalence
The article analyses regulatory documents containing requirements for clinical (trials) documentation for orally inhaled products, including requirements for the demonstration of therapeutic equivalence of medicinal products for the treatment of bronchial asthma and chronic obstructive pulmonary dis...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/132 |
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| _version_ | 1849393966922858496 |
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| author | E. S. Petrova D. V. Goryachev M. V. Petrov |
| author_facet | E. S. Petrova D. V. Goryachev M. V. Petrov |
| author_sort | E. S. Petrova |
| collection | DOAJ |
| description | The article analyses regulatory documents containing requirements for clinical (trials) documentation for orally inhaled products, including requirements for the demonstration of therapeutic equivalence of medicinal products for the treatment of bronchial asthma and chronic obstructive pulmonary disease in adults and children. The article summarises the main approaches to the assessment of inhalers equivalence. It also systematizes and describes dosage forms and inhalation devices, as well as the necessary stages of inhaler evaluation, looks into the methodology of conducting therapeutic equivalence studies with due regard to the therapeutic class of the drug, duration of its action and proposed nosology. The methodology includes requirements for the selection of the study population, study design and conditions, and recommendations for the selection of drug dose, study duration, primary and secondary efficacy and safety endpoints in the context of orally inhaled products. |
| format | Article |
| id | doaj-art-935dfdd99da847c7b3a450beafa596c4 |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-935dfdd99da847c7b3a450beafa596c42025-08-20T03:40:14ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-0173135141130Modern approaches to the assessment of orally inhaled products bioequivalenceE. S. Petrova0D. V. Goryachev1M. V. Petrov2Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe article analyses regulatory documents containing requirements for clinical (trials) documentation for orally inhaled products, including requirements for the demonstration of therapeutic equivalence of medicinal products for the treatment of bronchial asthma and chronic obstructive pulmonary disease in adults and children. The article summarises the main approaches to the assessment of inhalers equivalence. It also systematizes and describes dosage forms and inhalation devices, as well as the necessary stages of inhaler evaluation, looks into the methodology of conducting therapeutic equivalence studies with due regard to the therapeutic class of the drug, duration of its action and proposed nosology. The methodology includes requirements for the selection of the study population, study design and conditions, and recommendations for the selection of drug dose, study duration, primary and secondary efficacy and safety endpoints in the context of orally inhaled products.https://www.vedomostincesmp.ru/jour/article/view/132ингаляционные лекарственные препаратыингаляционные устройствафармакокинетикафармакодинамикабиоэквивалентностьтерапевтическая эквивалентностьконечные точки клинических исследованийкритерии оценки эффективности и безопасностиorally inhaled productsinhalation devicespharmacokineticspharmacodynamicsbioequivalencetherapeutic equivalenceprimary endpoints of clinical trialsefficacy and safety criteria |
| spellingShingle | E. S. Petrova D. V. Goryachev M. V. Petrov Modern approaches to the assessment of orally inhaled products bioequivalence Регуляторные исследования и экспертиза лекарственных средств ингаляционные лекарственные препараты ингаляционные устройства фармакокинетика фармакодинамика биоэквивалентность терапевтическая эквивалентность конечные точки клинических исследований критерии оценки эффективности и безопасности orally inhaled products inhalation devices pharmacokinetics pharmacodynamics bioequivalence therapeutic equivalence primary endpoints of clinical trials efficacy and safety criteria |
| title | Modern approaches to the assessment of orally inhaled products bioequivalence |
| title_full | Modern approaches to the assessment of orally inhaled products bioequivalence |
| title_fullStr | Modern approaches to the assessment of orally inhaled products bioequivalence |
| title_full_unstemmed | Modern approaches to the assessment of orally inhaled products bioequivalence |
| title_short | Modern approaches to the assessment of orally inhaled products bioequivalence |
| title_sort | modern approaches to the assessment of orally inhaled products bioequivalence |
| topic | ингаляционные лекарственные препараты ингаляционные устройства фармакокинетика фармакодинамика биоэквивалентность терапевтическая эквивалентность конечные точки клинических исследований критерии оценки эффективности и безопасности orally inhaled products inhalation devices pharmacokinetics pharmacodynamics bioequivalence therapeutic equivalence primary endpoints of clinical trials efficacy and safety criteria |
| url | https://www.vedomostincesmp.ru/jour/article/view/132 |
| work_keys_str_mv | AT espetrova modernapproachestotheassessmentoforallyinhaledproductsbioequivalence AT dvgoryachev modernapproachestotheassessmentoforallyinhaledproductsbioequivalence AT mvpetrov modernapproachestotheassessmentoforallyinhaledproductsbioequivalence |