This PBSS workshop, titled “Human PK and Dose Projection for Small Molecules: Fundamentals, Applications and Case Studies,” will cover strategies, best practices, and regulatory guidance for toxicological assessments to assess workplace safety, product quality/patient safety, and environmental toxicology. These assessments are critical for manufacturing, and essential for successful drug development. Included will be a discussion on occupational safety, toxicological risk assessment, impurities, and cleaning validation, and will cover different modalities such as biologics or small molecules.

In attendance from our Simulations Plus team will be John DiBella and Arlene Padron. Be sure to stop by our table and say hello.

We hope to see you there!

List of Topics:

• Prediction of Human Clearance
• Prediction of Human Volume of Distribution
• Prediction of Human Oral Absorption
• Prediction of Transporter-Mediated Hepatobiliary and Renal Clearance
• PK/PD and Human Dose Prediction
• Case Studies of Human PK and Dose Prediction
• Human PK & Dose Projection from the Tox Perspective: Relationship to First-in-Human Starting Dose and Dosing Regimen

Simulations Plus Staff in Attendance: 

• John DiBella, President, Physiologically Based Pharmacokinetics (PBPK), Cheminformatics
• Arlene Padron, Senior Director, Business Development