In the current environment, the pharmaceutical technologist is faced with an ever changing series of regulations, difficult to process drug substances and the time to make market entry and reach maximum product potential.
For many drug substance candidates, the inherent physicochemical and pharmacokinetic properties pose unique challenges necessitating the application of advanced solid dosage form technologies.
The same is true for innovators as well as generic firms that are manufacturing bioavailable products; which are seamlessly reviewed and reach the market quickly. Imbedded in this technical tapestry is the inevitable question of how large a batch needs to be, or more fundamentally, ‘what scale do I need to achieve?’. In many cases, the need for scaleup and the effort to achieve this are looked at as a major technical challenge.
To read more go to http://ipsdb.com/pdfs/IPS_Technologies_Tours.pdf#page=10"