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Биостатистика, фармакокинетика и клинические исследования.

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  1. Биоэквивалентность. ANOVA. Часть I.
  2. Биоэквивалентность. ANOVA. Часть II.
  3. Биоэквивалентность. ANOVA. Пример.
  4. Phoenix WinNonlin проект подтверждения метода.
  5. Биоэквивалентность. Расчет выборки.
  6. Пример расчета выборки с помощью итеративной процедуры.
  7. Пример расчета pooled CV и доверительного интервала для CV.
  8. Фармакокинетика. Основные понятия.
  9. Фармакокинетика. Основные понятия. Пример расчета ФК параметров.
  10. Phoenix WinNonlin проект подтверждения примера расчета ФК параметров.
  11. Планирование клинического исследования.
  12. Биоэквивалентность. ANOVA. Часть III.
  13. Таблица данных для тестового расчета.

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Галерея

DJI 0030
20180202 161155
DJI 0083
20170731 132822
20180814 160000
20180814 180918
  • Generic Drug User Fee Amendments
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-30 By FDA
  • October - December 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • eCTD Submission Standards for eCTD v3.2.2 and Regional M1
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • eCTD Submission Standards for eCTD v4.0 and Regional M1
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • Internet Pharmacy Warning Letters
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 36, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-08-29
  • Human medicines European public assessment report (EPAR): Darzalex, daratumumab, Date of authorisation: 20/05/2016, Revision: 25, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-08-29
  • Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Date of authorisation: 20/06/2019, Revision: 11, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-08-29
  • Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-08-29 By FDA
  • Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Date of authorisation: 27/03/2020, Revision: 10, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-08-29
  • Human medicines European public assessment report (EPAR): Jeraygo, aprocitentan, Revision: 2, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-08-29
  • Human medicines European public assessment report (EPAR): Spexotras, trametinib, Date of authorisation: 05/01/2024, Revision: 8, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-08-29
Предыдущие записи
Тема: Scaffold от Danny Cooper.