REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS
This article is intended for specialists on drug registration and specialists in clinical trials. There are analyzed the main projects of foreign documents regulating the amount of the registration program and the program of clinical trials required to bring to market the combined drugs. Article cla...
| Main Authors: | , |
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| Format: | Article |
| Language: | Russian |
| Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
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| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/179 |
| _version_ | 1826569805918896128 |
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| author | K. A. Yatsenko V. S. Berezina |
| author_facet | K. A. Yatsenko V. S. Berezina |
| author_sort | K. A. Yatsenko |
| collection | DOAJ |
| description | This article is intended for specialists on drug registration and specialists in clinical trials. There are analyzed the main projects of foreign documents regulating the amount of the registration program and the program of clinical trials required to bring to market the combined drugs. Article clarifies the principal possibility for development of certain combination types and gives comprehensive information about different clinical development strategy types of fixed combination medicinal products supported with evaluation of their applicability according to intended claim of the combination. Some practical recommendations for study design selection are also given. |
| first_indexed | 2024-04-10T01:41:24Z |
| format | Article |
| id | doaj.art-7368bbdbdec14020b2c3723525a8231d |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2025-03-14T11:45:11Z |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-7368bbdbdec14020b2c3723525a8231d2025-03-02T09:53:18ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0104222228179REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTSK. A. Yatsenko0V. S. Berezina1Centre of Clinical Trials. Co LtdCentre of Clinical Trials. Co LtdThis article is intended for specialists on drug registration and specialists in clinical trials. There are analyzed the main projects of foreign documents regulating the amount of the registration program and the program of clinical trials required to bring to market the combined drugs. Article clarifies the principal possibility for development of certain combination types and gives comprehensive information about different clinical development strategy types of fixed combination medicinal products supported with evaluation of their applicability according to intended claim of the combination. Some practical recommendations for study design selection are also given.https://www.pharmjournal.ru/jour/article/view/179clinical trialsclinical development programfixed combination medicinal products |
| spellingShingle | K. A. Yatsenko V. S. Berezina REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS Разработка и регистрация лекарственных средств clinical trials clinical development program fixed combination medicinal products |
| title | REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS |
| title_full | REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS |
| title_fullStr | REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS |
| title_full_unstemmed | REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS |
| title_short | REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS |
| title_sort | regulatory strategy of clinical development for fixed combination medicinal products |
| topic | clinical trials clinical development program fixed combination medicinal products |
| url | https://www.pharmjournal.ru/jour/article/view/179 |
| work_keys_str_mv | AT kayatsenko regulatorystrategyofclinicaldevelopmentforfixedcombinationmedicinalproducts AT vsberezina regulatorystrategyofclinicaldevelopmentforfixedcombinationmedicinalproducts |