Phase IV Trials

What is Phase IV Trials?

Phase IV Trials definition and meaning on Health terms:
Phase IV trials are usually conducted after marketing authorisation is granted and the medicine is in general use. Phase IV studies are also known as post-authorisation safety studies (PASS) and may be voluntary or imposed by the regulatory authorities. The possibility also exists of requesting the marketing authorisation holder to conduct post-authorisation efficacy studies (PAESs) in order to complement efficacy data that are available at the time of the initial authorisation. Phase IV studies collect additional information about side-effects and safety, long-term risks and benefits, and/or how well the medicine works when used widely. [mla_gallery meta_key=”eupasset_name” meta_value=”phases-clinical-development” columns=”1″ mla_caption=”{+caption+}” link=”file” size=”full”]

 

reference: https://www.eupati.eu/glossary/

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