行业会议

海外活动

Presentation title:

“The Best Use of 10 mg” - Achieve CMC Success through a Unique Optimization of Compound Benchwork and Computational Analysis

Abstract: Small Molecule drug discovery scientists have been trained to believe that they need gram scale quantities of API to determine CMC properties such as solubility, oral absorption, and salt selection to understand the formulation strategy. Crystal Pharmatech will unveil its proven approach to understanding the developmental risks through focused laboratory work and the most advanced computational approaches. You will understand how, with only 10 mg of material, you can move from late lead-op to FIH with a line-of-sight of your compound’s development path and significantly enhance your probability of success in the clinic.

Presentation title:

First in Human (FIH) Tablet Development for an Amorphous Unstable Prodrug with Enteric Coating Using an API Sparing Approach

Abstract: This presentation will explore the formulation and development process of First-In-Human (FIH) enteric-coated tablets at three dose strengths for an amorphous prodrug highly susceptible to hydrolysis under both acidic and basic conditions. We will delve into the scientific approaches employed to mitigate degradation pathways, ensure product stability through carefully selected excipients and optimized manufacturing techniques, and how material science-based approaches can lead to successful FIH product development within tight timelines.