Índice

  • 01

    COURSE INFORMATION

  • 02

    Cross-contamination and European Regulation

    • GMP Chapters

    • EMA Guidelines and EMA Q&A
  • 03

    Establishing Exposure Limits: PDE Calculation

    • PDE Definition

    • Regulation
  • 04

    Steps for Toxicological reports

    • PDE Strategy
  • 05

    Hazard identification

    • Pharmacodynamic

    • Acute Toxicity

    • Repeated dose toxicity

    • Carcinogenicity

    • Toxicity for reproduction
  • 06

    Critical effects

    • Preclinical data

    • Clinical data
  • 07

    Point of departure

    • Selection criteria

    • Options
  • 08

    Adjustement factors

    • From F1 to F5

    • Pharmacokinetic correction
  • 09

    Expert report content

    • Cover page according guidelines

    • PDE report content
  • 10

    EVALUATION

    • Exam