Minimum QbD, Enhanced QbD, and R&D QbD – How Are They Different?
I know what you are thinking. “We have no resources for implementing a full QbD. What is the minimum requirement to call our development process a QbD?” This article addresses that question. But it also provides a roadmap to enhance the “minimum QbD” over a period of time. Ildikó...
Cost of Developing Drugs: Why is it so High?
How much does it cost to develop a new drug? The answer, of course, depends on which product and which company we are dealing with. However, a Forbes journalist, Herper (2013) attempted to answer this question at a high level based on a study done by Dimasi (2003). As with...