Bioequivalence and Bioavailability Forum • Revised Imatinib Mesylate Tablets OGD by FDA

shaanthi_4u
☆

India,
2013-04-16 09:16
(4817 d 22:10 ago)

Posting: # 10421
Views: 13,486

Revised 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.

shaanthi_4u
☆

India,
2013-04-22 10:19
(4811 d 21:07 ago)

@ shaanthi_4u
Posting: # 10447
Views: 8,708

Revised Imatinib Mesylate Tablets OGD by FDA

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Dear All,
Because of safety reasons FDA must have proposed the biostudy of Imatinib Mesylate in stabilized CML or GIST patients to whom it is indicated for. But, will anyone please let me know how the study is feasible as the patients were on continuous dose and half life of Imatinib varies from 14 to 18 hrs, respectively. In such case, how the washout can be achieved and how patients stabilized with Imatinib Mesylate 400mg can be enrolled?

Edit: Please see the Forum’s Policy. [Helmut]

jodywood
●

2013-08-14 10:47
(4697 d 20:40 ago)

@ shaanthi_4u
Posting: # 11276
Views: 8,322

Revised Imatinib Mesylate Tablets OGD by FDA

Post reply

❝ 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.

The US Food and Drug Administration (FDA) approved imatinib (Gleevec, Novartis) for the treatment of newly diagnosed pediatric acute lymphoblastic leukemia (ALL) that is Philadelphia chromosome (Ph) positive. Side effects of Gleevec include swelling, nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

cloudmember ☆ Canada, 2013-08-29 17:25 (4682 d 14:01 ago) (edited on 2013-08-29 20:47) @ jodywood Posting: # 11386 Views: 8,230	Revised Imatinib Mesylate Tablets OGD by FDA Post reply
	Only logical explanation: Mistake in the guidance or semantic issues Is there any way to find out if this is the case? How could it be ' a single dose' when patients are already on the medication (considering the fact that Cmax might still be not far at the time of the single dosing)? A wash-out would be unethical and in the end we would have to use Steady State parameters for the BE anyway.