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Биостатистика, фармакокинетика и клинические исследования.

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Небольшая подборка полезной литературы

Опубликовано 6 марта, 201930 июня, 2019 frozencat

Data And Safety Monitoring Committees In Clinical Trials

Epidemiology and Biostatistics An Introduction to Clinical Research

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R

Clinical trial data analysis with R and SAS

Clinical Trials Design in Operative and Non Operative Invasive Procedures

Analyzing Longitudinal Clinical Trial Data: A Practical Guide

Bioequivalence and Statistics in Clinical Pharmacology, Second Edition

Design and Analysis of Bioavailability and Bioequivalence Studies

Biomaterials in Clinical Practice : Advances in Clinical Research and Medical Devices

Fundamental Statistical Inference A Computational Approach

Statistics and Simulation

Medical biostatistics

Biostatistics

Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development

Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Рубрики: Блог, Общее

Навигация по записям

Предыдущая запись: Расчет доверительных интервалов для 2X2 биоэквивалентности: Julia concept code
Следующая запись: Протокол и отчет клинического исследования биоэквивалентности: шаблон

Свежие записи

  • Long WS Wide: или про то, как выполнить анализ разницы изменений между группами
  • Частые вопросы: Регистрация и экспертиза по правилам ЕАЭС
  • Главные ошибки при формировании базы данных в MS Excel
  • Тест ClinicalTrialUtilities и ReplicateBE на Raspberry Pi 4
  • Julia:ReplicateBE – release 0.2.0

Галерея

20170730 183005
20170730 121723
20170802 170633
20180131 140107
IMG-20170730-WA0010
20180811 235329
  • Generic Drug User Fee Amendments
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-07-19 By FDA
  • International Activities
    Source: FDA - What's New: Vaccines, Blood & Biologics RSS Feed Published on 2025-07-19 By FDA
  • GDUFA Implementation Quarterly Meetings between FDA and Industry
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-07-18 By FDA
  • List of Drug Master Files (DMFs)
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-07-18 By FDA
  • Regenerative Medicine Advanced Therapy Designation
    Source: FDA - What's New: Vaccines, Blood & Biologics RSS Feed Published on 2025-07-18 By FDA
  • Human medicines European public assessment report (EPAR): Apremilast Accord, apremilast, Date of authorisation: 19/04/2024, Revision: 1, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
  • Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Date of authorisation: 20/06/2019, Revision: 10, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
  • E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials
    Source: FDA - What's New: Drugs RSS Feed Published on 2025-07-18 By FDA
  • Human medicines European public assessment report (EPAR): Ztalmy, ganaxolone, Date of authorisation: 26/07/2023, Revision: 5, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
  • Human medicines European public assessment report (EPAR): Lazcluze, lazertinib, Date of authorisation: 20/01/2025, Revision: 1, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
  • Human medicines European public assessment report (EPAR): Afqlir, aflibercept, Date of authorisation: 13/11/2024, Revision: 3, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
  • European Medicines Agency Write PMS API implementation Guide
    Source: EMA - Regulatory and procedural guidelines (human and veterinary) Published on 2025-07-18
  • Human medicines European public assessment report (EPAR): Osenvelt, denosumab, Date of authorisation: 14/02/2025, Revision: 3, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
  • Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 5, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
  • Human medicines European public assessment report (EPAR): Fampridine Accord, fampridine, Date of authorisation: 24/09/2020, Revision: 5, Status: Authorised
    Source: EMA - Human medicines: European public assessment reports (EPARs) Published on 2025-07-18
Предыдущие записи
Тема: Scaffold от Danny Cooper.