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RegisterBody surface area [Regulatives / Guidelines]
Dear Members
Please let me know, if body surface area (BSA) needs to be used for dose calculation in case of non-NTI drugs and in healthy subjects.
Also, confirm if an infusion study with long washout period which anticipated to significant change in weight, results in different dosages across the periods will require dose normalization?
Please let me know, if body surface area (BSA) needs to be used for dose calculation in case of non-NTI drugs and in healthy subjects.
Also, confirm if an infusion study with long washout period which anticipated to significant change in weight, results in different dosages across the periods will require dose normalization?
Complete thread:
- Body surface areaRock 2018-02-12 09:47 [Regulatives / Guidelines]
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Ing. Helmut Schütz