ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS
During the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ICH GCP. Thorough industrial standards are iss...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
|
| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/99 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1839586803116408832 |
|---|---|
| author | O. S. Kobyakova E. S. Kulikov I. A. Deev A. A. Dmitriev N. A. Tabakaev I. D. Pimenov D. S. Tyufilin |
| author_facet | O. S. Kobyakova E. S. Kulikov I. A. Deev A. A. Dmitriev N. A. Tabakaev I. D. Pimenov D. S. Tyufilin |
| author_sort | O. S. Kobyakova |
| collection | DOAJ |
| description | During the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ICH GCP. Thorough industrial standards are issued by global regulators: FDA and EMA. Currently there is absence of local regulatory documents on designing clinical trials in Russia, thus there might be a distinct need in development of national regulatory documents and its harmonization with international standards for pharmaceutical industry. |
| format | Article |
| id | doaj-art-a595feac23f940febd750ee10c965ab2 |
| institution | Matheson Library |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-a595feac23f940febd750ee10c965ab22025-08-03T19:23:52ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-010217217899ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALSO. S. Kobyakova0E. S. Kulikov1I. A. Deev2A. A. Dmitriev3N. A. Tabakaev4I. D. Pimenov5D. S. Tyufilin6Siberian State Medical UniversitySiberian State Medical UniversitySiberian State Medical UniversitySiberian State Medical UniversitySiberian State Medical UniversitySiberian State Medical UniversitySiberian State Medical UniversityDuring the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ICH GCP. Thorough industrial standards are issued by global regulators: FDA and EMA. Currently there is absence of local regulatory documents on designing clinical trials in Russia, thus there might be a distinct need in development of national regulatory documents and its harmonization with international standards for pharmaceutical industry.https://www.pharmjournal.ru/jour/article/view/99clinical trials designharmonizationregulator y requirementsichfdaema |
| spellingShingle | O. S. Kobyakova E. S. Kulikov I. A. Deev A. A. Dmitriev N. A. Tabakaev I. D. Pimenov D. S. Tyufilin ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS Разработка и регистрация лекарственных средств clinical trials design harmonization regulator y requirements ich fda ema |
| title | ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS |
| title_full | ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS |
| title_fullStr | ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS |
| title_full_unstemmed | ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS |
| title_short | ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS |
| title_sort | analysis of international requirements for designing of clinical trials |
| topic | clinical trials design harmonization regulator y requirements ich fda ema |
| url | https://www.pharmjournal.ru/jour/article/view/99 |
| work_keys_str_mv | AT oskobyakova analysisofinternationalrequirementsfordesigningofclinicaltrials AT eskulikov analysisofinternationalrequirementsfordesigningofclinicaltrials AT iadeev analysisofinternationalrequirementsfordesigningofclinicaltrials AT aadmitriev analysisofinternationalrequirementsfordesigningofclinicaltrials AT natabakaev analysisofinternationalrequirementsfordesigningofclinicaltrials AT idpimenov analysisofinternationalrequirementsfordesigningofclinicaltrials AT dstyufilin analysisofinternationalrequirementsfordesigningofclinicaltrials |