Pipeline-in-a-drug, page-20

Responding to post https://hotcopper.com.au/posts/74173206/single
(Broken button - so clunky!)

What are commonly called 'phase trials' do not need to be repeated. What is required is in vivo bioequivalence studies to show that the different form of the drug is equivalent to the previously approved version (i.e.: uptake, metabolisation, etc.). This is nowhere near as taxing or time consuming as the phase trial process leading to approval to use and market the drug,
Bioequivalence can be more challenging to achieve when moving from intrathecal administration to IV administration (due to the blood-brain barrier), or from IV administration to oral administration. Moving from solid to liquid via the same administration pathway is unlikely to pose difficulties - in fact (depending on whether the 'liquid' is a solution or a suspension) it may well be taken up more readily in liquid form requiring a retitration to lower the amount of API needed to achieve the same concentration in the blood.

Cheers

Densy