The Importance of the Human Mass Balance Study in Regulatory Submissions
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...
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| Main Authors: | , , |
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| Format: | Book |
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Wiley,
2019-11-01T00:00:00Z.
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Internet
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| Call Number: |
A1234.567 |
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