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Vismayi ☆ India, 2023-06-26 21:55 (469 d 17:08 ago) Posting: # 23614 Views: 2,037 |
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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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dshah ★★ India, 2023-06-27 10:46 (469 d 04:17 ago) @ Vismayi Posting: # 23618 Views: 1,665 |
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Dear Vismayi! ❝ 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. Generally patient are already on this medication. Stabilization periods means you have reached steady state with that formulation which generally takes about 3-5 half life of drug. Confirm after dosing for 3-5 halflife that C0 are constant. When changing the treatment, the same stabilization with new formulation needs to be applied. ❝ 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. If you are deviating from PSG- either design or healthy subject- kindly do CC with authority. Many a times, not even a single dose is recommended to HV. Regards, Divyen |
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Achievwin ★★ US, 2023-06-30 17:13 (465 d 21:50 ago) @ Vismayi Posting: # 23640 Views: 1,624 |
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❝ 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. Stabilization can be two things PK stabilization (close to steady state) or for treatment stabilization, you have to consult your medical expert or check the summary basis of approval it defines what is stable medication is (this may require certain cycles including drug free period). Once you determine what is this stabilization period you can always propose a replicate design to achieve efficient patient recruitment and retention. MY two cents |
Ing. Helmut Schütz