Bioequivalence and Bioavailability Forum

Hi Luvbloom

❝ Using coomen sense I mentioned that but I have a bit different run in with FDA on couple of products

❝ a) in one of our filing they didn't ask for data of any other lot of API

❝ b) In recent submission they asked for all the data

Learning curve

❝ ❝ ❝ b) Highest strength or highest dose??? ...

❝ Totally agreed to your point. But common sense also tells me that may be BSA of 2.18 will not be the right BSA for cancer patient. So does using the "absolute highest therapeutic dose thinkable" really make sense?

❝ If so why to cut it off at 5600 mg? Why not even higher?

I don't get the the point here, sorry For a biowaiver the absolute highest dose makes sense to me. Only if you can show that e.g. 99% of patients receive "highly soluble" doses and only 1% is on "low solubility" dose in practice this would matter. IMHO

❝ ❝ ❝ c) In case one have to take the body surface area for highest dose calculation ...

❝

❝ Again the same augument!

So why to use BSA of 2.18?

I never mentioned that figure

❝ In past we had the some arguments with FDA on the dose calculation using BSA and after long discussion FDA finally agreed on calculations based on BSA of 1.78-1.91 m2.

Sounds good! Go ahead!

If you want clarity write some comment to include the "dosing based on bodyweight" thing into the guidance with some sound suggestions (based on clinical practice) and see what happenz. You will never know before you start...

Happy weekend!