QbD Comes to India

Two good QbD seminars have been slated for March in Hyderabad and Mumbai, featuring consultant Line Lundsberg and Dhaval Trivedi of Intas Pharmaceuticals. Click here for more.

Global Outsourcing of Clinical Trials: Patient Concerns and Hope for Change

I've seen a number of news items come across my desk of late about Western companies forging partnerships to outsource clinical trials around the globe, particularly to India. Today's OpEd piece from UK's Guardian looks at some of the growing concern over fair treatment of patients as this trend plays out. The primary concern: "informed consent" can look good on paper but not necessarily be honored and practiced in situations in which trial patients are severely economically disadvantaged.

There are positives about the continued trend towards outsourcing trials overseas, of course. It's an opportunity to speed drug development, and to increase the availability of medications for "local diseases" around the world.

--Paul Thomas