API Supply for Pre-Clinical and Clinical Studies – Balancing Speed, Quality, and Cost

Speaker: Walter E. Stalzer, P.E., Director - Chemistry Consulting Services

Date: Tuesday, July 27, 2010
Time: 11:00 pm EDT

Introduction

Join us for a presentation on API Supply for Pre-Clinical and Clinical Studies – Balancing Speed, Quality, and Cost presented by Walter E. Stalzer, P.E., Director - Chemistry Consulting Services, of Ricerca Biosciences, LLC.

The on-time and cost-effective supply of high quality API is a vital component of any IP to IND drug development program. This presentation will discuss how to progress from the API discovery route to delivery of the released cGMP-grade API drug substance lot to be used for the Phase I clinical trials. Specific topics that will be covered are:

• Project Requirements and Expectations
• API Form Considerations
• Process Research Considerations
• Determination of API Requirements
• Preparation Risk Management
• Preparation Strategies and Planning
• Execution and Control

Registration

Registration here