Bioequivalence and Bioavailability Forum • lin-up/log-down any regulatory recommendation?

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

posted by Helmut – Vienna, Austria, 2017-05-21 21:14 (2525 d 00:53 ago) – Posting: # 17382
Views: 7,461

Hi Pjs,

❝ Thanks for the explanation :-) .

Would you mind answer my question from above? Did you use more significant digits?

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

No. Was recommended in the previous version of the WHO’s GL.

❝ Do this needs to be defined in the Protocol?

Exactly. Go ahead and update your SOP.

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Complete thread:

AUC calculation in bear pjs 2017-05-21 15:57 [🇷 for BE/BA]
- 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

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