multiple dose studies [Regulatives / Guidelines]

posted by Loky do – Egypt, 2024-01-21 17:15 (365 d 15:22 ago) – Posting: # 23835
Views: 2,618

Dears

We are planning to perform a multiple-dose study for tamsulosin prolonged-release tablets,
the proposal will be dosing for 7 days under fed conditions and sampling on the 7th day with a washout period of one week, as it is the first time to conduct this study, should we confine the subjects in the clinical site for the whole 7 days of dosing?

Thanks in advance

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