The Importance of the Human Mass Balance Study in Regulatory Submissions

• Main Authors: Paola Coppola (Author), Anita Andersson (Author), Susan Cole (Author)
• 格式: 图书
• 出版: Wiley, 2019-11-01T00:00:00Z.
• 主题: article
• 在线阅读: Connect to this object online.

The human mass balance study is a key study in the Clinical Pharmacology package of new drug applications. This study, along with the mass balance studies in toxicology species, provides essential information on the exposure of the parent compound and metabolites. Despite current regulatory guidance...