Selected references, guidelines and literature sources. Verify clinical statements against current local prescribing information and peer-reviewed literature.
Regulatory Guidelines #
- ICH Q1A(R2) Stability Testing
- ICH Q2(R1) Analytical Procedures Validation
- ICH Q3B(R2) Impurities
- ICH Q8 / Q9 / Q10 Development, Risk, Quality Systems
- WHO GMP Guidelines (WHO Technical Report Series)
- PIC/S PE 009 GMP Guide
- ISO 9001:2015 QMS Requirements
Clinical Guidelines #
- Thalassaemia International Federation (TIF) Guidelines
- British Society for Haematology - Iron Chelation
- NCCN Guidelines for MDS (current edition)
- American Society of Hematology - SCD Guidelines
Representative Clinical Studies #
- Cappellini MD et al. - deferasirox pivotal programme
- EPIC study programme
- Vichinsky E et al. - deferasirox in SCD
- List AF et al. - deferasirox in lower-risk MDS
- Pennell DJ et al. - cardiac iron mobilisation
Precise citations should be verified from original publications.
Regulatory Information Sources #
- EMA EPAR (deferasirox innovator)
- US FDA approved labelling
- CDSCO India prescribing information
- WHO Model List of Essential Medicines
Pharmacovigilance #
- CIOMS Working Group reports
- VigiAccess (WHO UMC)
- National PV authorities
Full Reference List #
Full citation lists supporting pharmacology, clinical and quality content are in the CTD Dossier Module 2, shared under CDA.