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The PharmaSchool JargonBuster is an online searchable dictionary of clinical research terms. You can either select the letter to display a list of terms or search by term.
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JargonBuster Result |
Adverse Drug Reaction (ADR) |
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function |
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PharmaSchool Regulatory Updates
PharmaSchool GCP & Regulatory Updates are notifications about changes, additions and new documents relating to the conduct of Clinical Trials. These are updated as and when new information is available. To access the searchable database of updates please click below:
GCP & Regulations Updates
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