Bioequivalence and Bioavailability Forum

lin-up/log-down any regulatory recommendation? [🇷 for BE/BA]

posted by pjs – India, 2017-05-21 21:08 (3318 d 16:05 ago) – Posting: # 17381
Views: 9,942

Dear Helmut,

Thanks for the explanation . Is there any regulatory requirement for the use of linup-logdown method.

As u explained there could be more bias in the AUC estimation in case of missing samples.

Do this needs to be defined in the Protocol?

This could become crucial incase of borderline study results for AUC.

Regards
pjs

Complete thread:

• AUC calculation in bear pjs 2017-05-21 15:57 
  • lin-up/log-down is bear’s default Helmut 2017-05-21 17:32
    • lin-up/log-down any regulatory recommendation?pjs 2017-05-21 19:08
      • lin-up/log-down any regulatory recommendation? Helmut 2017-05-21 19:14
        • lin-up/log-down any regulatory recommendation? pjs 2017-05-21 19:33
    • lin-up/log-down is bear’s default yjlee168 2017-05-21 20:08
      • lin-up/log-down is bear’s default Yura 2017-05-25 12:52
        • zero (0), missing (NA), or BLLOQ (0 or NA) in bear (II) yjlee168 2017-05-25 14:38
          • zero (0), missing (NA), or BLLOQ (0 or NA) in bear (II) Yura 2017-05-25 15:17
    • lin-up/log-down is bear’s default Astea 2017-05-22 02:12
      • Never use Excel Helmut 2017-05-22 13:19