Topic outline
Key Principles of Pharmacology
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 “confirmatory” clinical development versus
“Phases I-IV of clinical development”
Clinical Research from ECRAN project.
Phases of Clinical Development - image
Studies in early clinical development
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)
Definition of biomarkers and efficacy end-points
Early Clinical Development plan
Assessment
Quiz
Assessment Quiz
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