1. Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals. US Food and Drug Administration, July 2001 < http://www.fda.gov/cder/4461fnl.pdf > (2001).
2. ICH Final Draft Guidance for Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: Proposal for revision. 8 November 2000.
3. Pharmaceutical Research and Manufacturers of America (PhRMA), Phrma FAX of the Week, May 2, 2003, R&D Process: Long, Expensive, Risky Road.
4. Lin, J. H. & Lu, A. Y. Role of pharmacokinetics and metabolism in drug discovery and development. Pharmacol. Rev. 49, 403–449 (1997).
5. Gunaratna, C. Drug metabolism & pharmacokinetics in drug discovery: a primer for bioanalytical chemists, part I. Curr. Sep. 19, 17–23 (2000). This articles provides a good introduction to the fundamentals of drug metabolism