Introduction to the Meeting Clinical Pharmacology Subcommittee Advisory Committee for Pharmaceutical Sciences April 22-23, 2003 Rockville, Maryland - PowerPoint PPT Presentation

Loading...

PPT – Introduction to the Meeting Clinical Pharmacology Subcommittee Advisory Committee for Pharmaceutical Sciences April 22-23, 2003 Rockville, Maryland PowerPoint presentation | free to view - id: 43e27b-ZTdkY



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

Introduction to the Meeting Clinical Pharmacology Subcommittee Advisory Committee for Pharmaceutical Sciences April 22-23, 2003 Rockville, Maryland

Description:

Introduction to the Meeting Clinical Pharmacology Subcommittee Advisory Committee for Pharmaceutical Sciences April 22-23, 2003 Rockville, Maryland – PowerPoint PPT presentation

Number of Views:45
Avg rating:3.0/5.0

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: Introduction to the Meeting Clinical Pharmacology Subcommittee Advisory Committee for Pharmaceutical Sciences April 22-23, 2003 Rockville, Maryland


1
Introduction to the MeetingClinical
Pharmacology SubcommitteeAdvisory Committee for
Pharmaceutical SciencesApril 22-23,
2003Rockville, Maryland
  • Lawrence J. Lesko, Ph.D.
  • Director, Office of Clinical Pharmacology and
    Biopharmaceutics
  • Center for Drug Evaluation and Research
  • Food and Drug Administration

2
Whats New?
Improving Innovation in Medical Technology
Beyond 2002- Pink Sheet, February 3, 2003
3
Improving the Review Process Through A Quality
Systems Approach
  • Goals
  • application of advances in science
  • use of new technology
  • rigorous, analytic reviewer tools (how to do it)
  • quality reviews (effective, efficient,
    consistent)

4
Premarketing Risk Assessment
The process of identifying, estimating and
evaluating the nature and severity of risk from a
productRobert J. Meyer, M.D.ODE II
DirectorRisk Assessment Public MeetingApril 9,
2003
5
Ideal Safety Database
  • Complete characterization of the clinical
    exposure-response relationship
  • important E-R data for dose adjustments
  • Good search for individualization factors
  • studying individual plasma drug levels
  • always need assessment of polymorphic metabolism
  • Pediatrics
  • pose special issues related to dose, PK and PD

- Robert J. Temple, M.D., Associate Director
Medical Policy, April 9, 2003
6
Integrating Scientific Advances into Regulation
Pharmacogenetics
Genetic contributions to variability in toxicity
include differences in metabolism, e.g.,
thiopurine methyltransferase use of genetic
tests for metabolizer status to predict
dosingJanet Woodcock, M.D.Director, CDERFDA
Science Board MeetingApril 9, 2003
7
Topic 1 Proposal
  • Standardized approach to quantitate the impact of
    changes in exposure, related to efficacy or
    safety, that result from changes in PK caused by
    intrinsic and extrinsic factors
  • rational scientific basis for dosing adjustments
  • goal of identifying individualization factors
  • consistency in label recommendations

8
Topic 2 Proposal
  • Pediatric PPK study design template
  • use to develop pediatric PK (PD) information
    during drug development
  • Research proposal to analyze the FDA pediatric
    database
  • patterns of changes in PK (PD) related to age
  • re-evaluate the pediatric decision tree

9
Topic 3 Work in Progress
  • Pharmacogenetics to improve existing drug
    treatments
  • polymorphic drug metabolizing enzymes that
    influence variability in drug response,
    especially toxicity
  • how much of PK variability does genetics explain?
  • how much of an effect on drug response will
    genetics explain?
  • what criteria is needed to support genomic
    information in label?
  • develop a rationale scientific basis for
    regulatory processes and policies

10
Topic 4 New
  • Metabolism- and transport-based drug-drug
    interactions
  • some matters always need assessment, including
    new interactions, e.g., inhibition of
    glucuronidation and PGP
  • Issues and questions
  • use and extension of a classification system for
    CYP 3A4 inhibition for single and multiple drug
    interactions
  • when and how should the role of p-glycoprotein in
    drug interactions be investigated?

11
Broad Questions Specific Questions for
Discussion Come Later
  • Are the proposals (topics 1 and 2) being made
    today reasonable and feasible?
  • Will they enhance the quality of drug
    development and regulatory review?
  • Will the works in progress (topics 3 and 4)
    achieve worthwhile objectives?
  • What is the best way to integrate the new science
    and technology into therapeutics and regulatory
    review?

12
Conclusion
We look forward to the discussionWe are sure
that the experience and expertise of this
subcommittee can refine and expand on the
proposals and ideas presented today
About PowerShow.com