Bioequivalence and Bioavailability Forum

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
                                              this Parameter
─────────────────────────────────────────────────────────────────────────────────────────
TRT       Investigational Ther-  UNII         Conditionally   If study type is
          apy or Treatment                    Required        “INTERVENTIONAL” this para-
                                                              meter is required.
COMPTRT   Comparative Treat-     SRS Prefer-  If Applicable   If applicable.
          ment Name              red Sub-                     Don’t include if there are
                                 stance Name                  no active comparators.
                                                              Use as many rows as needed.
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:

• The study is interventional. Hence TRT is required and the name of the test product given in TSPARAM and 5Q7ZVV76EI given in TSVAL.
  
• In BE we have an active comparator. For the FDA it is the RLD used in the study (Warfarin Sodium 10 mg of BMS Pharma). Hence, COUMADIN in TSPARAM and Warfarin in TSVAL.