125 - Dissolution Testing & Bioequivalence (S9E5)

Explore dissolution testing's vital role in predicting in vivo drug performance and supporting bioequivalence, especially for generic drugs. Uncover how it uses a variety of specialized apparatus to replicate various stomach and intestinal environments, and then simulates digestion. The analysis highlights the significance of carefully choosing the right liquid medium and apparatus to truly capture dissolution dynamics. Discuss how it helps ensure generic and brand name versions release the drug in a similar way.The analysis then walks you through interpreting the results, particularly around evaluating the dissolution profile, where it shows a graph of what percentage dissolves over time. Find out how new drugs get assessed, for not only getting the drug to work, but also to help understand its safety and effectiveness. Gain insight into what changes are made to the process, such as when changes to the excipients may occur, to ensure bioequivalence. Gain insight into how dissolution testing helps create safe and effective medication and why it is essential.