mwagh
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India,
2016-12-16 12:07
(2659 d 19:51 ago)

Posting: # 16848
Views: 3,363
 

 TS.xpt for bioequivalence study [Regulatives / Guidelines]

Hi,

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.

Or is there any other suggested option?

Thanks,
Helmut
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Vienna, Austria,
2016-12-16 14:19
(2659 d 17:40 ago)

@ mwagh
Posting: # 16849
Views: 2,944
 

 CDISC SDTM

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.

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