1. FDA. 2005. Guidance for industry. Nonclinical studies for the safety evaluation of pharmaceutical excipients. Available at: http://www.fda.gov/cder/guidances/5544fnl.pdf.
2. IPEC-Americas' update significant change guide for bulk pharmaceutical excipients;Silverstein;Pharm Technol,2005
3. PQRI survey of pharmaceutical excipient testing and control strategies used by excipient manufacturers, excipient distributors, and drug-product manufacturers;Larner;Pharm Technol,2006
4. FDA. 2004. Guidance for industry, PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance. Available at: http://www/fda.gov/cder/guidance/6419fnl.pdf.
5. FDA/ICH. 2006. Guidance for industry. Q8 pharmaceutical development. Available at: http://www.fda.gov/cder/guidance/6746fnl.pdf.