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Create PK CDISC Domains in Minutes Using PK Submit™️

In this 30-minute webinar, you will learn about PK Submit, a new add-on to Phoenix WinNonlin that automates the creation of PK CDISC domains during NCA analysis.  It can generate both Study Data Tabulation Model (SDTM) and Standard for Exchange of Nonclinical Data (SEND) datasets. PK Submit was designed to create the entire PK regulatory … Continued

FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts

Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued

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