mwagh ☆ India, 2016-12-16 12:07 (2659 d 19:51 ago) Posting: # 16848 Views: 3,363 |
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Hi, For a bioequivalence study, while creating the TS.xpt which approach should be followed
Or is there any other suggested option? Thanks, |
Helmut ★★★ Vienna, Austria, 2016-12-16 14:19 (2659 d 17:40 ago) @ mwagh Posting: # 16849 Views: 2,944 |
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Hi mwagh, ❝ For a bioequivalence study, while creating the TS.xpt which approach should be followed ❝ ❝ 1. Assign the drugname value to TRT variable and Keep COMPTRT blank. ❝ 2. Assign the same drug name value to both TRT and COMPTRT variable. #1 would be wrong. According to CDISC SDTM, Appendix C:
TSPARMCD TSPARM TSVAL Record with Notes UNII (Unique Ingredient Identifier) is an identifier for a single defined substance. The UNII is a non-proprietary, free, unique, unambiguous, non semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. Use the FDA’s SRS/UNII search. Example: Warfarin gives 5Q7ZVV76EI .Just my two cents for the warfarin example:
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