OT: Reality vs Guidance [Regulatives / Guidelines]

posted by luvblooms  – India, 2015-05-15 14:09 (3559 d 11:06 ago) – Posting: # 14826
Views: 3,962

Hi Nobody

❝ Use common sense: All relevant batches should be studied, IMHO


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

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


❝ Again: Common sense, only the WORST CASE, i.e. absolute highest therapeutic dose thinkable makes sense. If there is a "switch" from high to low solubility within the therapeutic dose range, might be interesting to the authority...


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?

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


Again the same augument!
A recent study showed that in a total of 3613 patients receiving chemotherapy for head and neck, ovarian, lung, upper GI/pancreas, breast or colorectal cancers were included, The overall mean BSA was 1.79 m2 (95% CI 1.78–1.80) with a mean BSA for men of 1.91 m2 (1.90–1.92) and 1.71 m2 (1.70–1.72) for women. So why to use BSA of 2.18?

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.

So better to get clarity on the stupid questions that one have :-D

~A happy Soul~

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