Early Clinical Development

Topic outline

• Select section Key Principles of Pharmacology

  Key Principles of Pharmacology

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  After completing this course, you will be able to:

  • Understand the principles of pharmacology, methods of measuring and;
  • Describe the types of studies in early clinical development (Phase I and Phase II studies).

   

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• Select section Key Principles of Pharmacology

  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.

  If you would like to watch this video in any of 18 other languages, please click here: http://vimeo.com/ecranproject/videos/sort:alphabetical/format:thumbnail
  

  Phases of Clinical Development - image

  

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• Select section Studies in early clinical development

  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

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• Select section Human Pharmacology (Phase I) & Therapeutic Exploratory (Phase II)

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

  • Select activity Phase I - Human Pharmacology

    

    Phase I - Human Pharmacology Book

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  • Select activity Phase II - Typically Therapeutic Exploratory

    

    Phase II - Typically Therapeutic Exploratory Book

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• Select section Definition of biomarkers and efficacy end-points

  Definition of biomarkers and efficacy end-points

  • Select activity Preamble: The Concept of Biomarkers

    

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  • Select activity Definition of biomarkers and efficacy end-points

    

    Definition of biomarkers and efficacy end-points Book

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• Select section Early Clinical Development plan

  Early Clinical Development plan

  • Select activity Early Clinical Development Plan

    

    Early Clinical Development Plan Book

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• Select section Assessment

  Assessment

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