Problem Definition: In 1992, FDA instituted the accelerated approval pathway (AP) to allow promising drugs to enter the market based on limited evidence of efficacy, thereby permitting manufacturers to verify true clinical benefits through post-market studies. However, most post-market studies...

One of the most important trends in the pharmaceutical industry is the rapid growth of specialty drugs. Specialty drugs, mostly bio-based, tend to be high-risk, high-priced, and more regulated than traditional drugs, resulting in unprecedented challenges in distribution. Such challenges lead to...