Clinical Pharmacology: Modeling and Simulation M

1
Clinical Pharmacology Modeling and Simulation
(MS)

• Lawrence J. Lesko
• Office of Clinical Pharmacology and
  Biopharmaceutics (OCPB)
• Food and Drug Administration
• Advisory Committee for Pharmaceutical Science
• Rockville, Maryland
• 16 November 2000

2
The Past

• MS is already an integral part of the way the
  FDA conducts business
• applications in clinical pharmacology,
  biostatistics, and clinical medicine
• Consensus view of need
• better integration of MS across discipline lines
• common technical framework to ensure usefulness

3
Success Stories

• BE of metered dose inhaler, and topical
  corticosteroid products
• Approval of products for Rx and OTC use where
  there are specific safety questions
• Approval of changes in doses, dosing regimens and
  routes of administration
• Guidances in the clinical pharmacology master
  plan

4
Future Vision

• An integrated MS environment that will develop,
  apply and/or rely upon models and simulations
  that support
• regulatory decision-making process
• drug development activities
• advanced planning for clinical trials

5
Significant Opportunities

• Animal PK/TK data to support FDIM
• Dose-response data to develop and refine the
  process for clinical dose selection
• PK/PD relationships to interpret observational PK
  changes in patient subsets
• CTS to explore the full range of critical study
  design issues to allow for trade-off decisions

6
High Potential Payoffs

• Reduce cost, in time and money, of the drug
  development process
• Increase the assurance and quality of regulatory
  decision making
• Better drug products, and information for use,
  made available to the American public

7
Plan for Today

• New trends in MS that can be employed in drug
  development (M. Hale)
• Joint FDA working group looking into MS
  technologies and standards (P. Lee)
• Expertise of advanced users of MS technology (D.
  Mould and R. LaLonde)