OT: Reality vs Guidance [Regulatives / Guidelines]
❝ 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
Kindest regards, nobody
Complete thread:
- FDA - Biowaiver Class III nobody 2015-05-12 10:01 [Regulatives / Guidelines]
- FDA - Biowaiver Class III Helmut 2015-05-12 12:27
- FDA - Biowaiver Class III nobody 2015-05-12 13:14
- FDA - Biowaiver Class III jag009 2015-05-14 16:31
- FDA - Biowaiver Class III Helmut 2015-05-14 18:51
- OT: Reality vs Guidance luvblooms 2015-05-15 07:31
- OT: Reality vs Guidancenobody 2015-05-15 10:34
- OT: Reality vs Guidance luvblooms 2015-05-15 12:09
- OT: Reality vs Guidance nobody 2015-05-15 16:40
- OT: Reality vs Guidance luvblooms 2015-05-15 12:09
- OT: Reality vs Guidancenobody 2015-05-15 10:34
- FDA - Biowaiver Class III Helmut 2015-05-12 12:27