Bioequivalence and Bioavailability Forum

Zero Data in Suppositories BE Test Siswanto 2023-08-12 09:18 [Study Assessment]
- Zero Data in Suppositories BE Test dshah 2023-08-14 16:15
  - Zero Data in Suppositories BE Test Siswanto 2023-08-15 02:18
    - Zero Data in Suppositories BE Test dshah 2023-08-15 11:07

Fed-fasted BE studies using different polymorphs london12 2009-08-25 14:21 [Regulatives / Guidelines]
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44
  - Fed-fasted BE studies using different polymorphs Ohlbe 2009-08-31 01:34
    - Submission of 'failed' studies Helmut 2009-08-31 15:36
      - Submission of 'failed' studies Ohlbe 2009-08-31 23:01
  - Fed-fasted BE studies using different polymorphs qualityassurance 2023-08-03 10:44

BCS class I (dispersible tablet): selection of reference product yuva 2023-08-01 11:23 [Regulatives / Guidelines]
- BCS class I (dispersible tablet): selection of reference product dshah 2023-08-01 12:36

a bug of bear 2.9.1 froot 2023-08-01 07:13 [🇷 for BE/BA]

non-accuracy and precision validation runs in ICH M10 guideline avinash 2023-06-30 09:28 [Regulatives / Guidelines]
- Inaccuracy, precision acc. to IUPAC Helmut 2023-06-30 11:33
  - Inaccuracy, precision acc. to IUPAC avinash 2023-07-03 08:21
- non-accuracy and precision validation runs in ICH M10 guideline Ohlbe 2023-07-10 09:29
  - non-accuracy and precision validation runs in ICH M10 guideline avinash 2023-07-28 05:25

Non-accuracy and precision validation runs as per M10 guideline avinash 2023-07-27 13:16 [Regulatives / Guidelines]

M-CERSI in-person workshop on PBBM: Aug 29-31 SMA 2023-07-17 14:53 [Conferences / Workshops]

Adhesion Score Analysis durga09 2023-07-17 11:15 [Design Issues]

FDA: PD BE study balakotu 2023-07-12 04:24 [Power / Sample Size]
- FDA: PD BE study dshah 2023-07-13 08:45

any SAS or R-macro for 3 period two sequence RSABEIs Achievwin 2023-07-05 18:38 [RSABE / ABEL]
- Use the one for TRTR | RTRT Helmut 2023-07-06 08:46
  - RSABE R coded by Detlew mittyri 2023-07-06 14:07
    - ‘dlat’ for 3-period full replicate? Helmut 2023-07-07 14:41
      - ‘dlat’ for 3-period full replicate? mittyri 2023-07-07 16:04
        
        Likely wrong workaround? Helmut 2023-07-07 20:06
        
        a bit corrected workaround mittyri 2023-07-07 22:52
        
        THX! Another attempt… Helmut 2023-07-08 12:15
        
        complete.cases for dlat and ilat? mittyri 2023-07-09 21:45
        
        a bit corrected workaround Achievwin 2023-07-10 20:43

missing points around tmax Imph 2023-07-02 11:33 [NCA / SHAM]
- Exclude the subject(s) Helmut 2023-07-02 14:15
  - predose sample is missing Imph 2023-07-04 10:15
    - predose sample is missing Helmut 2023-07-04 10:25
    - predose sample is missing dshah 2023-07-05 07:37
      - predose sample is missing Helmut 2023-07-05 09:08
        
        predose sample is missing Imph 2023-07-06 07:07
        
        predose sample is missing dshah 2023-07-10 16:57
- missing points around tmax dshah 2023-07-03 08:25

Specificity requirement for FDC and concomitant medication karthik0210 2023-07-01 08:19 [Bioanalytics]
- Specificity requirement for FDC and concomitant medication qualityassurance 2023-07-07 09:06
- Specificity requirement for FDC and concomitant medication Ohlbe 2023-07-10 09:43

SFDA BE GL v3.1 (also GCC?) Helmut 2023-06-23 08:55 [Regulatives / Guidelines]
- SFDA BE GL v3.1 (also GCC?) khaledazeid 2023-07-01 18:09
  - SFDA BE GL v3.1 (GCC reference?) Helmut 2023-07-01 21:54
- SFDA BE GL v3.1 (also GCC?) wienui 2023-07-04 17:35
  - SFDA BE GL v3.1 (also GCC) Helmut 2023-07-04 19:46

Stabilization period Vismayi 2023-06-26 19:55 [Design Issues]
- Stabilization period dshah 2023-06-27 08:46
- Stabilization period Achievwin 2023-06-30 15:13

Sensitization test Kelen 2023-06-30 13:13 [Regulatives / Guidelines]

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