Newsletter - July 13, 2017
Why is India a Great Location for BA/BE Studies But Not For Clinical Trials?
About half of all BA/BE studies to support generic drug applications are conducted in India. On the other hand, only about 2% of interventional clinical trials have sites in India. And it does not seem that these numbers will change in the near future. To see the cause for this huge disparity, one needs to.. Read More
Innovative Trial Design to Speed Up FDA Approval
Traditional clinical trials are designed to evaluate one drug in the treatment of one indication. Many patients are screened to find the few that perfectly match the inclusion criteria of the trial and rest are rejected. Screen failures could account for as high as half of the patients who initially showed interest in participating in a given trial. Read More
Why is India a Great Location for BA/BE Studies But Not For Clinical Trials?
About half of all BA/BE studies to support generic drug applications are conducted in India. On the other hand, only about 2% of interventional clinical trials have sites in India. And it does not seem that these numbers will change in the near future. To see the cause for this huge disparity, one needs to.. Read More
Innovative Trial Design to Speed Up FDA Approval
Traditional clinical trials are designed to evaluate one drug in the treatment of one indication. Many patients are screened to find the few that perfectly match the inclusion criteria of the trial and rest are rejected. Screen failures could account for as high as half of the patients who initially showed interest in participating in a given trial. Read More
