Unique Considerations for Biopharmaceutics

This chapter contains sections titled: Introduction and Background Selection of the Molecule: Contrasts to Small-Molecule Considerations Production and Process Considerations in Pre-FIH Development Bioanalytical Assay Considerations Objectives and Implementation of Pre-FIH Safety Assessment Programs Post-IND Considerations: Support of Phases II and III and Registration The TeGenero Incident and Implications for Biopharmaceutic Nonclinical Safety Evaluation Programs Conclusions References