1. A. Eylath at al., Pharm. Technol.
36 (5) 54–58 (2012).
2. FDA, Guidance for Industry: cGMP for Phase 1 Investigational Drugs (July 2008 FDA).
3. S.P. Boudreau et al., Pharm. Technol.
28 (11) 54–66 (2004).
4. M. Bloch, "Validation During Drug Product Development – Considerations as a Function of the Stage of Drug Development,"
Method Validation in Pharmaceutical Analysis, a Guide to Best Practice, Eds. J. Ermer, J.H. Miller (Wiley, 2005), pp. 243–264.
5. ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology (Nov. 2005).
6. ICH, Q7A Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients (Aug. 2001).
7. FDA, Draft Guidance for Industry: Analytical Procedures and Method Validation, Chemistry, Manufacturing and Controls Documentation (Aug. 2000).
8. EMA, Guideline on the Limits of Genotoxic Impurities (June 2006).
9. FDA, Draft Guidance for Industry: Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches