Early Clinical Development Plan

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4. Types of Study and Their Objectives

Clinical studies classification according to Objective (ICH E8):


Clinical Phase
Type of Study
Objective of Study
Examples
Phase I
Human Pharmacology - Pharmacokinetics and Tolerability
  • Assess Tolerance.
  • Define/Describe PK and PD.
  • Explore metabolism of medicine and interactions.
  • Estimate activity.
  • Dose-tolerance studies.
  • Single and multiple dose PK and/or PD studies.
  • Medicine interaction studies.
Phase II
Therapeutic Exploratory - Effect
  • Explore use for the targeted indication.
  • Estimate dosage for later studies.
  • Provide basis for confirmatory study design, endpoints, methodologies.
  • Earliest trials of relatively short duration in well-defined small patient populations, using surrogate or pharmacological endpoints or clinical measures.
  • Dose-response exploration studies.