Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

then you have two choices. file as a new drug starting from square 1 or file an amendment to your previously approved drug and jump directly to phase 3 testing. which do you think a company would do? if you choose go directly to phase 3 then continue.

NEVER HAPPEN

For one thing... it's not what the company wants... it's what the FDA REQUIRES or ACCEPTS.

Here are my feelings on it.

I'm also not sure they would not need to start with a phase 1 study, as that is the phase which primarily focuses on safety... after all IPCI claims that they can give a lethal dose of the drug without affecting the patient... you don't prove that in phase 3... you prove it, and very slowly and carefully, in phase 1 where you dose 1 person, wait to see results... dose 2 people, wait to see results... dose 4 people etc. etc... luckily, unlike cancer, we don't need to wait months or years to see results - you dose the first patient at night... and if he wakes up in the morning... you're good to go dose the next 2... LOL.

On second thought... I now believe that they will be required to do extensive in vitro BE tests before they are even allowed to begin phase 1

They will probably be required to assimilate gastric acidity levels (replicate an artificial gastro-intestinal environment) in vitro... drop ~ 10 Rexista PODRAS in the solution, and then measure the amount of oxycodone released in the solution to ascertain that it would be safe for human use... All this before they would allow even the first human patient to be dosed in the phase 1.

Of course, there is always naltraxone??? (sp) which would neutralize the oxycodone should something go wrong in the phase 1 study.