Clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia - Scientific guideline
Table of contents
This document provides guidance on the clinical evaluation of medicinal products intended for the treatment of chronic immune thrombocytopenia.
Keywords: Chronic primary immune thrombocytopenia, thrombopoietin receptor agonists
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Overview of comments received on “Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia” (PDF/310.3 KB)
First published: 28/03/2014
Last updated: 28/03/2014
EMA/652909/2013 -
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Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia (PDF/180.98 KB)
Draft: consultation closed
First published: 20/03/2013
Last updated: 20/03/2013
Consultation dates: 20/03/2013 to 31/08/2013
EMA/CHMP/153191/2013
- Clinical efficacy and safety: blood and blood-forming organs
- Clinical efficacy and safety: antineoplastic and immunomodulating agents
- Directive 2001/83/EC
Good pharmacovigilance practices: Module V - Risk management systems- Application with 1. Meta-analyses; 2. One pivotal study - Scientific guideline
- Choice of a non-inferiority margin - Scientific guideline
- Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Scientific guideline
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety - Scientific guideline
- ICH E9 statistical principles for clinical trials - Scientific guideline
- ICH E10 Choice of control group in clinical trials - Scientific guideline
- ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline
- Investigation of drug interactions - Scientific guideline
- Missing data in confirmatory clinical trials - Scientific guideline