REFERENCES
- ICH, Stability testing on New Drug Substances and Products. International Conference on Harmonization, Q1A (R2) IFPMA, Geneva , 2003 .
- Sarvanan , G. ; Rao , B.M. ; Ravikumar , M. ; Suryanarayana , M.V. ; Someswararao , N. ; Acharyulu , P.V.R. Chromatographia 2007 , 66 , 287 – 290 .
- Ahuja , S. Impurities evaluation of pharmaceuticals ; Marcel Dekker, Inc. : New York , USA , 1998 .
- ICH, Harmonized Tripartite Guideline, Q1E: Evaluation of stability data , 2003 .
- ICH, Harmonized Tripartite Guideline, Q1F: Stability data package for registration applications in climatic zones III and IV , London , 2003 .
- ICH, Photo stability testing on New Drug Substances and Products. International Conference on Harmonization, Q1B 1996 .
- ICH, Guidance for Industry: Q3B (R2) Impurities in New Drug Products; Centre for Drug Evaluation and Research (CDER) , Rockville , 2006 .
- FDA: Drugs at FDA, Revlimid: http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/, http://www.revlimid.com/pdf/REVLIMID_PI.pdf,
- EMEA: European Medicines Agency, Revlimid, http://www.emea.europa.eu/humandocs/PDFs/EPAR/revlimid/H-717-en6.pdf,
- ICH, Validation of Analytical Procedures: Text and Methodology International Conference on Harmonization Q2 (R1) IFPMA , Geneva , 2005 .
- FDA, Guidance for Industry: Analytical Procedures and Methods Validation (Draft Guidance), Food and Drug administration , Rockville , 2000 .