Topic outline

Key Principles of Pharmacology

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The early clinical development plan: the objectives, designs including minimisation of bias, conduct and analysis of early exploratory development studies, incl. role of Pos; “Exploratory” and “confirmatoryclinical development versus “Phases I-IV of clinical development

Clinical Research from ECRAN project.

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Phases of Clinical Development - image
phases clinical development

Studies in early clinical development

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The objective of ADME studies is to understand and characterise a medicine’s absorption, distribution, metabolism, and excretion. Although usually associated with Phase I, these studies may be performed throughout the development of a medicinal product. These studies are typically performed using a single dose in healthy males (n=4-6) using the intended route of administration.

The information gained from ADME studies is:
  • Distribution of parent medicine and metabolites in different body compartments (e.g. after crossing the blood-brain barrier)
  • Proportion of parent medicine converted into metabolite(s)
  • Primary mechanism(s) of elimination and excretion from the body

Human Pharmacology (Phase I) & Therapeutic Exploratory (Phase II)

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Definition of biomarkers and efficacy end-points

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Early Clinical Development plan

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Assessment

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