Which CTD section should the reports of bioanalytical and analytical methods for human PK study be presented?

刊登日期：2019-10-25 | 點閱次數 : 1102 次

The reports of bioanalytical and analytical methods for human PK study can be included in the clinical study report or be presented in CTD Module 5.3.1.4.

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Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation

Which CTD section should the reports of bioanalytical and analytical methods for human PK study be presented?

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