Stabilization period [Design Issues]

posted by Vismayi – India, 2023-06-26 21:55 (97 d 11:02 ago) – Posting: # 23614
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Good morning to one and all,

This is regarding patient PK study, we have upcoming study.

Indication: Ovary cancer

In this study,we need to stabilize patients but for how many days neither it is mentioned in specific guidance nor product leaflet. So, what duration we should we consider for stabilization.

Beside,study product can be taken until patient tolerate as per leaflet.

If the disease pre-valence is less and this may lead to challenge in recruitment. So can we consider replicate design over conventional two-way.

Edit: Category changed; see also this post #1[Helmut]

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