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RegisterRevised Imatinib Mesylate Tablets OGD by FDA [Design Issues]
Dear All,
FDA has revised the OGD of Imatinib Mesylate Tablets. Instead of steadystate, crossover in stabilized chronic phase CML or GIST patients with 400mg dose, FDA recommends a single dose, crossover study in the same patient population. Would like to know whether such study is feasible bearing in mind the patient regimen where patients will be on continuous dose of Imatinib 400mg. Also it may not be possible to conduct a single dose study as the patient population need to receive a stable dose of Imatinib 400mg.
Hence kindly let me know the reason for FDA recommending a study in patients when Imatinib, which is not cytotoxic can be dosed in healthy.
FDA has revised the OGD of Imatinib Mesylate Tablets. Instead of steadystate, crossover in stabilized chronic phase CML or GIST patients with 400mg dose, FDA recommends a single dose, crossover study in the same patient population. Would like to know whether such study is feasible bearing in mind the patient regimen where patients will be on continuous dose of Imatinib 400mg. Also it may not be possible to conduct a single dose study as the patient population need to receive a stable dose of Imatinib 400mg.
Hence kindly let me know the reason for FDA recommending a study in patients when Imatinib, which is not cytotoxic can be dosed in healthy.
Complete thread:
- Revised Imatinib Mesylate Tablets OGD by FDAshaanthi_4u 2013-04-16 07:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Revised Imatinib Mesylate Tablets OGD by FDA shaanthi_4u 2013-04-22 08:19
- Revised Imatinib Mesylate Tablets OGD by FDA jodywood 2013-08-14 08:47
- Revised Imatinib Mesylate Tablets OGD by FDA cloudmember 2013-08-29 15:25
Ing. Helmut Schütz