CLINICAL DEVELOPMENT STRATEGY FOR COPIES OF PREVIOUSLY REGISTERED DRUGS. PART 3. PROTOCOL OF CLINICAL TRIAL OF BIOEQUIVALENCE
Recommendations presented in the article are based on current regulations and guidelines of regulatory authorities on clinical trials of bioequivalence and professional experience of authors and will be useful for medical writers to plan clinical trial lege artis. Article gives information about cho...
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| 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/97 |
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| Summary: | Recommendations presented in the article are based on current regulations and guidelines of regulatory authorities on clinical trials of bioequivalence and professional experience of authors and will be useful for medical writers to plan clinical trial lege artis. Article gives information about choice of inclusion / exclusion criteria, reference, dosages evaluated, study design, bioanalytical method validation, outcome measures and acceptance criteria for resulting protocol. |
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| ISSN: | 2305-2066 2658-5049 |