Bioequivalence and Bioavailability Forum

Terminology: Fed study Pharma_88 2021-01-20 11:15

Definition of Generic Drug in Mexico jag009 2021-01-05 00:25

Chinese BE GL Helmut 2020-12-30 11:37
- Chinese BE GL ElMaestro 2020-12-30 11:54
  - Chinese BE GL Helmut 2020-12-30 12:16
- no luck so far... mittyri 2020-12-30 22:23
- Chinese BE GL 0521 2021-01-04 08:31
  - HVD(P)s? Helmut 2021-01-04 10:47
    - HVD(P)s? 0521 2021-01-04 12:10
      - China RSABE Helmut 2021-01-04 15:49
        
        China DNS != Google DNS mittyri 2021-01-04 22:16

WHO frequent deficiencies in protocols and reports Ohlbe 2020-12-04 12:04
- WHO frequent deficiencies in protocols and reports ElMaestro 2020-12-04 14:10
  - CI inclusion ≠ TOST Helmut 2020-12-04 20:30
    - CI inclusion ≠ TOST d_labes 2020-12-05 16:19
      - CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
        
        CI inclusion ≠ TOST d_labes 2020-12-07 11:39
      - CI inclusion ≠ TOST Helmut 2020-12-06 22:09
        
        CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
        
        WHO lamenting about terminology? Helmut 2020-12-07 13:02
        
        WHO lamenting about terminology? ElMaestro 2020-12-07 14:54
        WHO lamenting about terminology? d_labes 2020-12-07 15:35
- WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 19:00
  - "obtain balanced groups" vs randomisation ElMaestro 2020-12-23 08:12

Biowaiver for Lower Strength vandee 2020-11-23 06:52
- Biowaiver for Lower Strength Ohlbe 2020-11-23 10:41
  - Biowaiver for Lower Strength vandee 2020-11-25 06:17
- Biowaiver for Lower Strength wienui 2020-11-24 10:42
  - Biowaiver for Lower Strength vandee 2020-11-25 06:21

ambulatory samples in bioequivalence studies yoyo87 2020-11-22 10:06
- large deviations from schedule Helmut 2020-11-23 12:18

Accepted time deviations in Ambulatory PK intervals Researcher101 2020-11-20 17:59
- Accepted time deviations in Ambulatory PK intervals ElMaestro 2020-11-21 10:08
  - Accepted time deviations in Ambulatory PK intervals Researcher101 2020-11-22 11:52
  - Accepted time deviations in Ambulatory PK intervals Helmut 2020-11-23 11:49

highly variable drugs-Cmax nuka2020 2020-11-19 11:09
- GCC: HV Cmax (fixed limits) Helmut 2020-11-19 12:05
- highly variable drugs-Cmax wienui 2020-11-19 18:04
  - highly variable drugs-Cmax Helmut 2020-11-19 20:58

Reference product in bioequivalence slebr 2020-11-04 10:02

Thailand FDA Bioequivalence Guideline Pharma_88 2020-10-22 06:49
- Thailand FDA Bioequivalence Guideline Brus 2020-10-22 09:16

Russia BE Study Anand 2015-03-27 05:28
- Russia BE Study Beholder 2015-03-27 09:46
  - Russia BE Study Anand 2015-03-27 10:24
    - Russia BE Study Beholder 2015-03-27 12:21
      - Red Book? Helmut 2015-03-27 14:16
        
        Red Book? Yeah... Beholder 2015-03-29 16:36
        
        Red Book? Yeah... Alyssa 2020-10-05 06:00
        
        Red Book? Yeah... Beholder 2020-10-05 11:34
  - Russia BE Study Brus 2020-10-01 16:05
    - Russia BE Study Helmut 2020-10-01 16:47
      - Russia BE Study Brus 2020-10-01 16:51
        
        Russia BE Study Helmut 2020-10-01 17:02
        
        Russia BE Study Beholder 2020-10-02 09:24
    - Russia BE Study Beholder 2020-10-03 19:51
      - Russia BE Study Brus 2020-10-21 10:42
- Russia BE guidelines Ohlbe 2015-03-27 09:52

Retention period and quantity for Malaysian submission Sriramprasad 2020-07-18 09:06
- Retention period and quantity for Malaysian submission cakhatri 2020-08-10 08:04
  - Retention period and quantity for Malaysian submission Sriramprasad 2020-10-17 13:54

bioequivalence criteria for NTID Biostats 2018-03-29 12:39
- bioequivalence criteria for NTID Helmut 2018-03-29 14:27
  - bioequivalence criteria for NTID Biostats 2018-03-30 06:25
    - GMR not relevant in ABE Helmut 2018-03-30 11:19
      - Presentation of data in report and SAS output arl_stat 2020-10-15 16:12
- bioequivalence criteria for NTID jag009 2018-03-29 17:20

ICH M9 - reverse engineering? MSimoes 2020-09-16 16:01
- ICH M9 - reverse engineering? dshah 2020-09-17 06:46
  - ICH M9 - reverse engineering? MSimoes 2020-09-17 15:56
    - ICH M9 - reverse engineering? dshah 2020-09-30 07:27

Bioequivalence Limit, Power and interpretation Pharma_88 2020-09-22 13:27
- Bioequivalence Limit, Power and interpretation Helmut 2020-09-22 13:59
- Power and sensitivity analyses Helmut 2020-09-25 13:42

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