OT: Reality vs Guidance [Regulatives / Guidelines]

posted by nobody – 2015-05-15 12:34 (3557 d 19:06 ago) – Posting: # 14824
Views: 3,991

❝ What baffles me the most is


❝ a) ...of different/all the lots of API used in different batches of formulation...


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

❝ 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...

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


See b)

;-)

Kindest regards, nobody

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