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- An alias for the actual product name is used rather than the actual product name.
- Exposure data are collected in non-protocol-specified units.
- Scheduled and/or missed exposures are collected.
- Planned doses (e.g., a calculation based on body weight) exposures are collected in addition to actual doses givenexposures.
A sponsor An applicant may choose to always collect exposure data using the CDASHIG EC domain.Extensive discussion of the use of the EC and EX domains, including examples of data collection, is available in the SDTMIG.
Specifications
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Exposure (EX)
Exposure as Collected (EC)
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Overview
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