C2-M3 Exploratory and Confirmatory Clinical Development

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Learning outcomes module 3:

3A    Define intended therapeutic indication, its limitations and criteria for “go” “no-go” decisions and its final description

3B    Describe the early clinical development plan and clinical study types (phases) and their objectives beginning with “first in human” and the different ways in which Patients/POs can contribute

3C    Critically appraise the role of pharmacogenetics / pharmacogenomics in the development of medicines and discuss the ethical challenges

3D    Outline the basic principles of pharmacokinetics and their application to dose-finding and in subsequent phases of drug development

3E    Define Life Cycle Management of a medicine, its purposes and possible approaches via post marketing trials

3F    Evaluate and compare the emerging techniques in specific product development or disease areas

3G    Discuss the advantages and critical aspects of global coordination / harmonisation of clinical trial programmes before and after marketing authorisation

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