Guidelines - ICH
Guidelines - ICH
CPMP/ICH/135/95 - Note for Guidance on Good Clinical Practice
CPMP/ICH/379/95 - Note for Guidance on Studies in Support of Special Populations: Geriatrics
CPMP/ICH/291/95 - Note for Guidance on General Considerations for Clinical Trials
CPMP/ICH/363/96 - Note for Guidance on Statistical Principles for Clinical Trials
CPMP/ICH/364/96 - Note for Guidance on Choice of Control Group in Clinical Trials
CPMP/ICH/2711/99 Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population
CPMP/ICH/137/95 ¿Note for Guidance on Structure and Content of Clinical Study Reports
CPMP/ICH/378/95 - Note for Guidance on Dose Response Information to Support Drug Registration
EMA/CHMP/ICH/309348/2008 - ICH guideline E2F Note for guidance on development safety update reports
CPMP/ICH/375/95 - Note for Guidance on Population Exposure: The Extent of Population Exposure to Assess Clinical Safety
CPMP/ICH/377/95 - Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
EMA/CHMP/ICH/287/1995 - ICH guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide
CPMP/ICH/289/95 - Note for Guidance on Ethical Factors in the Acceptability of Foreign Clinical Data
QUESTIONS AND ANSWERS - (CPMP/ICH/289/95)
EMA/CPMP/ICH/286/1995 - ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals
Na seguinte página da Agência Europeia do Medicamento (EMA) podem ser consultadas todas as guidelines ICH e as restantes guidelines disponibilizadas pela EMA:
