- This domain contains details regarding the collection of PK samples from subjects (e.g., timing of sample collection, associated specimen properties) at the investigational site. Typically, collection does not include concentration results generated by a bioanalytical laboratory. However, if the applicant has occasion to collect concentration results on the same CRF, variables may be created based on CDASH Model variables, using the rules previously discussed.
- Other data (e.g., demographics, vital signs, substance use, exposure) may be needed for PK analysis. See the TIG collection sections for these related domains.
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