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Preclinical, Clinical, and Translational Sciences
Partner Presentation

PK/TK Strategy in Drug Development: Optimizing Design, Execution, and Data Integrity

Monday, November 10, 2025
12:00 PM - 1:00 PM CT
Location:360 Stage #3, Exhibit Hall

Sponsored By 
Preclinical & Translation Sciences Partner Presentation-Preclinical

    Partner Presentation Speaker(s)

  • Sara Underwood

    Senior Pharmacokineticist
    Alturas Analytics, Inc.
    Moscow, Idaho

Description: Pharmacokinetic and toxicokinetic data must inform regulatory and development decisions with precision. This session highlights how suboptimal study design, flawed exposure profiles, and operational errors degrade data utility. We’ll explore best practices in dose selection, matrix and timepoint planning, and executional rigor — all within the context of regulatory expectations. Attendees will gain actionable insights to strengthen study design and interpretability across early-phase development.

Learning Objectives:

  • Design and justify PK/TK protocols that support IND-enabling objectives and regulatory requirements.
  • Identify and mitigate common sources of variability in sampling strategies and protocol execution.
  • Evaluate the impact of strategic CRO alignment on data integrity, timeline adherence, and regulatory review readiness.