Loky do

2024-01-21 17:15
(36 d 22:43 ago)

Posting: # 23835
Views: 518

 multiple dose studies [Regulatives / Guidelines]


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

India/United Kingdom,
2024-01-22 11:03
(36 d 04:55 ago)

@ Loky do
Posting: # 23836
Views: 414

 multiple dose studies

Dear Loky do!

It will be good to confine the subjects which can confirm that subject have taken dose on recommended time, not missed any dose, food is standardized (high fat/low fat/ standard food) and consumed by volunteers. There can be other things added- but if you plan not to confine till 7th day- how does that ensure that subjects have followed protocol compliance?


India/United Kingdom,
2024-01-26 11:03
(32 d 04:56 ago)

@ dshah
Posting: # 23841
Views: 314

 Css level?

Dear Loky do!

Further, few additional sampling will be required to show that steady state has reached.

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