Steady State achieve­ment [Design Issues]

posted by rajasekharkakarla – India, 2019-07-03 08:02  – Posting: # 20369
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Dear All,

Greetings for the day!!!

I am designing steady state protocol for Dalfampridine Extended Release Tablets 10 mg, as per EMEA Smpc I written protocol as daily twice dosing for 5 days with 12 hours interval and 6th day only morning dose followed by PK samples.

Here my doubt is for evaluating the steady state achievement whether consideration of predose samples at morning doses is sufficient or we need to take predose samples at evening dose also.

Generally to evaluate steady state achievement we will consider at least last 3 pre-dose samples including PK sampling day.

Please help me!!!

Regards,
Rajasekhar K


Edit: Category changed and subject line changed; see also this post #1, #2.
The EMEA was renamed to EMA back in 2005. There is no “EMA SmPC”, only SmPCs of the reference – which might differ between countries. [Helmut]

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