Bioequivalence and Bioavailability Forum

Dear all,

we have panned to conduct a patient pk study for below indications.

patient population:

Advanced ovarian cancer
Recurrent ovarian cancer

Advanced ovarian cancer:
300 mg dose is recommended whose weight is greater than 77 kg.
200 mg dose is recommended whose weight is less than 77 kg.

Recurrent ovarian cancer:
300 mg dose.
No weight criteria.

Considering practical challenge, it is difficult to get patient whose weight is above 77 kg.
but we usually do study on highest strength.

So, I can't recruit patients for advanced ovarian cancer for 300 mg.

The only category left is recurrent cancer patients.

If i want to recruit advanced ovarian c. patients whose weight less than 77 to facilitate recruitment then what are statistical methods available which accepts mixed strength 300 mg and 200 mg.

Please share expert opinion.

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