While significant progress has been made in developing treatments for rare diseases—highlighted by the approval of over 800 drugs for orphan diseases since ...

A major part of the drug development process is to weed out those compounds whose side effects overwhelm their therapeutic effects. This gets to the fundamental issue of efficacy vs effectiveness.

In conventional drug development, QA processes often ... For instance, automated testing platforms can rapidly process samples and generate detailed reports in real-time. This capability is ...

Drug discovery and development is an extremely lengthy and expensive process; yet drug safety, a fundamental part of this process, continues to be a major unaddressed problem. The problem of ...

$802 million = Cost to develop a new drug. 12-15 years = Time required from ... adverse events/toxicities. Obtain and process blood samples or other specialized samples. Facilitate referrals ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

The preparation of the Common Technical Document (CTD), a mandatory component involving extensive data compilation for regulatory submissions, exemplifies a process that could benefit from AI ...

"C-Path was built on the vision that no single entity can solve the challenges of the drug development process alone," said former C-Path CEO Dr. Woosley. "Over the last 20 years, C-Path has ...