Formulation Development

FORMULATION DEVELOPMENT – Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form

John Baumann, Dan Dobry, and Rod Ray, PhD, review the development and use of amorphous SDDs and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms.

GENOMIC BIOMARKERS – EGFR Mutations, Apoptosis & Gefitinib Response: A Model for Integrating Genomic Biomarkers Into Successful Precision Medicine

Sirosh Bokhari, PhD, says by not recognizing the importance of integrating biomarkers early in drug development and not considering companion diagnostics as an ultimate goal, companies would not be ready to select a companion diagnostic partner and negotiate agreements with long-term implications.