1. FDA nonclinical laboratory studies good laboratory practice regulations ( http://www.fda.gov/ora/compliance_ref/bimo/glp/78fr-glpfinalrule.pdf ).
2. FDA 21 CFR part 58 good laboratory practice regulations final rule ( http://www.fda.gov/ora/compliance_ref/bimo/glp/87fr-glpamendment.pdf ).
3. FDA, Guideline for submitting documentation for the stability of human drugs and biologics, 1987.
4. FDA, Guidance for industry: stability testing of drug substances and drug products (draft guidance), 1998.
5. Organisation for Economic Co-operation and Development (OECD) Principles of good laboratory practice, [ENV/MC/CHEM(98)17] 1998.