The International Council for Harmonisation (ICH): 'E' group of guidelines

Below is the overview of 'E' group of ICH guidelines that collectively apply to different stages and types of pre- / clinical research and development.

 

ICH: ‘E’ group of guidelines overview

 

General Considerations for Clinical Studies:

E 8 (R1) ICH Consensus Guideline

 

Design and Analysis:

E4 Dose-Response Studies

E9 Statistical principles for Clinical Trials

E10 Choice of Control Group in Clinical Trials

E17 Multi-Regional Clinical Trials

Conduct and Reporting:

E3 Clinical Study Reports

Safety Reporting:

E1 Clinical Safety for Drugs used in Long-Term Treatment

E2A – E2F Pharmacovigilance

E14 Clinical Evaluation of QT

E19 Safety Data Collection

 

Populations:

E5 Ethnic Factors

E7 Clinical Trials in Geriatric Population

E11 – E11A Clinical Trials in Pediatric Polulations

E12 Clinical Evaluation by Therapeutic Category

Genetics / Genomics

E15 Definitions in Pharmacogenetics/Pharmacogenomics

E16 Qualification of Genomic Biomarkers

E18 Genomic Sampling

 

Other EU Guidelines:

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

 

 

Author: European Medicines Agency

Clinical Research News

The 'Hidden' Cholesterol Diet Can't Fix: New Drug to Be Tested on Heart Artery Plaque
The 'Hidden' Cholesterol Diet Can't Fix: New Drug to Be Tested on Heart Artery Plaque
When a Migraine Pill Doesn't Fully Work: Pfizer to Test Rimegepant Redosing
Psilocybin for Parkinson’s: Scientists Are Testing a Depression Treatment, Not a 'Magic Mushroom' Cure
When GLP-1 Fails: Novo Nordisk Explores a Different Path for Weight Management
Menopause Hot Flashes May Be More Than Just 'Heat': A Well-Known Drug to Be Tested for Vascular and Memory Links
Beyond Hormones: A New GLP-1 Drug Enters Early Trials for PCOS

Próximos ensaios clínicos

Clinical Research Jobs

More jobs

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

Se inscrever