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Quintiles Limited - Articles and news items
Industry news / 24 April 2014 / Biogen Idec
Quintiles and Biogen Idec have entered into a five-year strategic clinical development agreement…
Q1: Please outline the general process of Phase I clinical trials.
Burnand: Phase I is the screening for safety process and it’s the first time that a product is given to a human being. The aim at this stage is to demonstrate that the product isn’t dangerous. The data will alsol be used to determine the dosage for the Phase II stage and we estimate that between 20 – 100 healthy volunteers participate (and in some cases they are not healthy volunteers, where there will be some known side effects, but generally they are healthy).
Drug development has become more complex and significantly more expensive. There has been an estimated 55% increase in the critical path development costs since the year 20001. More than 50% of these costs are incurred in later phase development (Phase IIb and III studies).
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