1. Timing of new black box warnings and withdrawals for prescription medications;Lasser;JAMA,2002
2. Guidance for Industry: Safety Testing of Drug Metabolites;Food and Drug Administration (FDA),2008
3. International Conference on Harmonization (ICH) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization of Pharmaceuticals,2010
4. FDA Guidance for Industry: Safety Testing of Drug Metabolites,2016
5. FDA Guidance for Industry: Safety Testing of Drug Metabolites Guidance for Industry,2020