The Importance of the Human Mass Balance Study in Regulatory
https://ascpt.onlinelibrary.wiley.com/doi/10.1002/psp4.12466
WEB19 rows · Sep 12, 2019 · In the EMA drug interaction guidance 3 (Appendix V of the guidance), consistent with the MIST guidance, it is suggested that effort should be made to identify as much of the dose-related material as possible. It is generally recommended that metabolites contributing to > 10% of the AUC of drug-related material (i.e., radioactivity in a well ...
DA: 87 PA: 100 MOZ Rank: 13