Reference glossary of clinical, pharmacological, regulatory and commercial terms used across the DEFRATAJ website.
A - B #
- ACTD
- ASEAN Common Technical Dossier - harmonised registration format for ASEAN.
- ALT / AST
- Liver-function enzymes monitored during chelation therapy.
- ANVISA
- Brazilian Health Regulatory Agency.
- APQR
- Annual Product Quality Review - GMP-required annual batch review.
- BE
- Bioequivalence - comparative PK study vs reference product.
C #
- CAPA
- Corrective and Preventive Action.
- Cardiac T2*
- MRI measure of myocardial iron; < 20 ms suggests cardiac iron risk.
- CoA
- Certificate of Analysis - batch-specific QC results.
- COFEPRIS
- Mexican regulatory authority.
- CoPP
- Certificate of Pharmaceutical Product - WHO-format for export registration.
- CQA
- Critical Quality Attribute.
- CPP
- Critical Process Parameter.
- CTD
- Common Technical Document - Module 1-5 dossier format.
D - E #
- DDP
- Delivered Duty Paid - Incoterm.
- DRESS
- Drug Reaction with Eosinophilia and Systemic Symptoms.
- EAEU
- Eurasian Economic Union harmonised registration.
- eCTD
- Electronic CTD format.
F - L #
- FOB
- Free On Board - Incoterm.
- Ferritin
- Serum iron-storage protein; primary iron-overload biomarker.
- HDPE
- High-Density Polyethylene - bottle material.
- ICH
- International Council for Harmonisation.
- ICSR
- Individual Case Safety Report.
- IPSS / IPSS-R
- MDS risk stratification.
- LIC
- Liver Iron Concentration - MRI R2/T2* gold standard.
M - P #
- MAH
- Marketing Authorization Holder.
- MDS
- Myelodysplastic Syndromes.
- NTDT
- Non-Transfusion-Dependent Thalassemia.
- OOS
- Out of Specification.
- PIC/S
- Pharmaceutical Inspection Co-operation Scheme.
- PPQ
- Process Performance Qualification.
- PSUR
- Periodic Safety Update Report.
Q - Z #
- QA / QC
- Quality Assurance / Quality Control.
- QP
- Qualified Person - batch release authority.
- SCAR
- Severe Cutaneous Adverse Reactions - SJS, TEN, DRESS.
- SCD
- Sickle Cell Disease.
- SJS
- Stevens-Johnson Syndrome - detachment < 10% BSA.
- SmPC
- Summary of Product Characteristics.
- TEN
- Toxic Epidermal Necrolysis - detachment > 30% BSA.
- UGT1A1
- Hepatic enzyme; deferasirox glucuronidation.
- WHO-GMP
- WHO Good Manufacturing Practices.
- WHO-PQ
- WHO Prequalification programme.