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clinical trial application
Definition
A clinical trials application is the required tools in which a sponsor (and individual, corporate body, institution or organization) applies to have a new drug product approved for sale in or importation to a region . The sponsor is expected to show scientific evidence of the drug's safety, efficacy and quality. While the effects of a new drug on people can be measured in other ways, such as astute observation or anecdotal evidence, a clinical trial is the best scientific approach to provide clear and reliable data. Specifically, a clinical trial is used to determine whether a drug is safe and effective, what dosages are most effective, and what side effects a drug may cause.
Abbreviation for
CTA
Related Term
application type
clinical trial authorization
investigational medicinal product dossier
 

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