Demystifying Highly Potent API And Cytotoxic Drug Products

By Sharada Kolindrekar, Director of Continuous Improvement, Technology, and Validation (CITV), and Devan Patel, Senior Director, Project Management, Pharmaceutics International, Inc. (Pii)

Thirteenth century philosopher Ibn Yami is credited with the origins of a design framework referred to as “Knowns and Unknowns.” He initially captured the idea in a verse, “one who knows and knows that he knows…his horse of wisdom will reach the skies.”

This framework re-emerged in the 1950s as the Johari Window, a tool used to help people better understand their relationship with themselves and others. Several decades later NASA used the same framework to develop the re-entry plan for the Space Shuttle that factored in all the known and unknown risks.

At Pii, although we aren’t involved in interplanetary navigation, we do apply the concept of the “Knowns and Unknowns” framework in drug development and process design, especially for highly potent active pharmaceutical ingredients (HPAPI) and cytoxic drug products.