Основы клинической эпидемиологии и доказательной медицины
ebm.org.uaРегуляторные органыichEfficacyICH E8: Общие соглашения относительно проведения клинических исследованийПриложение: Список применимых руководств и тем



Приложение: Список применимых руководств и тем

Приложение

Список соответствующих Руководств и Тем ICH
Code Topic
E1 The Extent of Population Exposure to Assess Clinical Safety for Drug Intended for Long-term Treatment of Non-Life-Threatening Conditions
E2A Clinical Safety Data Management: Definitions and Standards for expedited Reporting
E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
E3 Structure and Content of Clinical Study Reports
E4 Dose-Response Information to Support Drug Registration
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data
E6 Good Clinical Practice: Consolidated Guideline
E7 Studies in Support of Special Populations: Geriatrics
E8 General Considerations for Clinical Trials
E9 Statistical Considerations in the Design of Clinical Trials
E10 Choice of Control Group in Clinical Trials
M3 Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
S6 Safety Studies for Biotechnology-Derived Products







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