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EVENT OVERVIEW
This webinar will present strategies for fast, efficient, and effective analytical method development for preclinical and early clinical development programs. In most cases, development and qualification of analytical methods is rate-limiting for drug candidates moving rapidly from discovery to first-in-man studies. The key to success is to balance the tasks of performing sufficient method development to ensure safety in the clinical programs; building a base of scientific knowledge to support development; and meeting development timelines with available resources. Presentations will include discussions and case studies for:
• rapid chromatographic method development
for preclinical drug programs
• analytical method problem solving for early
clinical development formulations
KEY LEARNING OBJECTIVES
• Understand how to rapidly develop analytical
methods for preclinical drug programs
• Identify and solve problems with analytical
methods for early clinical formulations
• Understand trade-offs between available scientific
knowledge and project deadlines from an analytical
method development perspective
WHO SHOULD ATTEND
• Analytical development scientists responsible for
development and validation of test methods for preclinical
and early clinical development programs
• Project managers responsible for coordination of
preclinical and early clinical development program
• Regulatory CMC specialists involved with preparation
of IND/CTX documentation for first-in-man studies
• Formulation scientists involved with early-stage formulation
for toxicology and Phase I clinical studies
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