01.10.23 -- Micronization Technology For HPAPI Development & Manufacturing

Explore how to classify HPAPIs in early development and recommendations for safe product handling, from clinical manufacturing to commercialization, as well as key advantages of using micronization technology for the development and manufacture of HPAPIs.

A QbD approach was used to solve a high-performance liquid chromatography analytical method problem where impurity peaks had shifting retention times, making identification and quantitation problematic.

Experts share principles, advantages, and disadvantages of different dose forms and considerations for selecting a suitable dosage form for early-phase development programs to commercialization.