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Product Development :-
Definitions:-
This document outlines the Taj pharmaceuticals product development
portfolio as of
31-DEC-11
including new molecular entities and major line
extensions. The portfolio will change with time as compounds enter
from research, progress through to the next phase of development
or enter the market place. The high risk nature of the drug
development process also means that it is not unusual for some
projects to be terminated if they do not meet the criteria for
progression and this will be particularly true in the early
stages.
Definitions:-
Phase 0:
Successful lead optimisation compounds will move into what we
call phase zero. These are compounds where specific studies for
registration have been initiated and preparation is underway for
entry into humans.
Phase 1: Phase 1 is defined as the stage of development
where safety studies are initiated and the drug first enter
humans.
Phase 2: This phase of development represents the first
trials of study efficacy of the compound in humans.
Phase 3: This represents the larger clinical trial usually
involving a comparision against a standard comparator compound in
preparation for the registration of the compound and approval by
regulatory authorities.
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