myCSG © |Area: SDTM| Concept: PP : Pharmacokinetics Parameters | Lesson: L101 : Pharmacokinetics Parameters - Drug in plasma |
Basic programming of SDTM.PP domain
Parameters are derived for samples collected on day 1 and day 11 dosing
5 Parameters are reported
Pharamcokinetic parameter data is generally obtained from vendors and not directly collected on CRF
Lesson description will be added soon
Parameters are derived for samples collected on day 1 and day 11 dosing
5 Parameters are reported
Pharamcokinetic parameter data is generally obtained from vendors and not directly collected on CRF
Lesson description will be added soon
PCON : Pharamcokinetic concentrations
| Question | Response |
|---|---|
| Dosing day [GRPID] |
Day 1 Day 11 |
| Date/time of dosing [DOSING_TIME] |
|
| Planned Timepoint [PCTPT] |
PREDOSE 1H30MIN 6H 24H |
| Date of collection [PCDAT_RAW] |
|
| Time of collection [PCTIM] |
|
| Specimen [SPEC] |
Plasma |
| Analyte [ANALYTE] |
Drug A |
| Unit [UNIT] |
ng/mL |
| Concentration [RESULT] |
|
PPARAM : Pharamcokinetic parameters (vendor)
| Question | Response |
|---|---|
| Dosing day [GRPID] |
Day 1_DrugA Day 11_DrugA |
| Specimen [SPEC] |
Plasma |
| Parameter [PARAM] |
TMAX (H) CMAX (ug/L) AUCALL (h*mg/L) LAMZHL (H) VZO (L) |
| Result [RESULT] |
|
| SUPP | VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT | FORM_PPARAM |
|---|---|---|---|---|---|
| _ | STUDYID | Study Identifier | Char | Populate as "statschoice" | |
| _ | DOMAIN | Domain Abbreviation | Char | Populate as "PP" | |
| _ | USUBJID | Unique Subject Identifier | Char | Populate by concatenating "statschoice-" to the value of subject as a prefix. | |
| _ | PPSEQ | Sequence Number | Num | Sort the records by USUBJID, PPCAT, PPTESTCD, VISITNUM and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject.  |
|
| _ | PPGRPID | Group ID | Char | Populate with the value from GRPID variable. | |
| _ | PPTESTCD | Parameter Short Name | Char | Populate with the first word from PARAM variable where '(' is the delimiter. | |
| _ | PPTEST | Parameter Name | Char | Set to "Time of CMAX" when PPTESTCD="TMAX". Set to "Max Conc" when PPTESTCD="CMAX". Set to "AUC All" when PPTESTCD="AUCALL". Set to "Half-Life Lambda z" when PPTESTCD="LAMZHL". Set to "Vz Obs" when PPTESTCD="VZO". |
|
| _ | PPCAT | Parameter Category | Char | Populate with the second word from GRPID variable where '_' is the delimiter. | |
| _ | PPORRES | Result or Finding in Original Units | Char | Populate with the value from RESULT variable. | |
| _ | PPORRESU | Original Units | Char | Populate with the second word from PARAM variable where '(', ')' are the delimiters. | |
| _ | PPSTRESC | Character Result/Finding in Std Format | Char | Populate with the value from PPORRES variable | |
| _ | PPSTRESN | Numeric Result/Finding in Standard Units | Num | Convert PPSTRESC to numeric value where applicable. | |
| _ | PPSTRESU | Standard Units | Char | Populate with the value from PPORRESU variable | |
| _ | PPSPEC | Specimen Material Type | Char | Populate with the value from SPEC variable. | |
| _ | PPRFTDTC | Date/Time of Reference Point | Char | Populate using PCON dataset. Merge PPARAM and PCON datasets at subject and GRPID variables level and fetch DOSING_TIME from PCON as PPRFTDTC. Notes: 1) Use only first word from GRPID variable of PPARAM dataset. 2) Multiple records exist in PCON for each SUBJECT and GRPID - first record can be used as DOSING_TIME is expected to be same on all records of a GRPID. |
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