Bioequivalence and Bioavailability Forum

ICH E6(R3) draft Guideline reaches Step 2 of the ICH process SMA 2023-05-24 08:37 [BE/BA News]
- Validation of sample size estimations? Helmut 2023-05-29 08:34

Washout based on mean ± SD of t½ Imph 2022-09-25 13:52 [Design Issues]
- Washout based on mean ± SD of t½ Helmut 2022-09-25 16:08
  - Washout based on mean ± SD of t½ Imph 2022-09-26 15:24
    - Washout based on mean ± SD of t½ Shuanghe 2022-09-26 17:34
    - Washout based on mean ± SD of t½ Helmut 2022-09-26 17:35
    - If you have data… Helmut 2022-09-27 11:52
      - If you have data… Imph 2022-10-25 09:21
  - Washout based on mean ± SD of t½ Imph 2023-05-26 23:31
    - Washout based on mean ± SD of t½ Helmut 2023-05-27 06:52
      - Washout based on mean ± SD of t½ Imph 2023-05-27 08:36

Sample Size Benefits of Replicate Design with ABE Sereng 2023-05-24 15:41 [Power / Sample Size]
- Sample Size Benefits of Replicate Design with ABE dshah 2023-05-25 09:56
- Dropouts less problematic Helmut 2023-05-25 16:27

Data analysis and sample size for replicate study designs as per recent FDA guidance balakotu 2023-05-23 12:16 [Regulatives / Guidelines]

regulatory guideline wock 2023-05-22 06:06 [Regulatives / Guidelines]

Sexy… Helmut 2023-05-19 20:32 [Off Topic]
- Apotex vs MSN mittyri 2023-05-20 20:38

FDA’s mixed model for ABE: another round Helmut 2019-08-19 13:07 [🇷 for BE/BA]
- emmeans for lme when the data is incomplete mittyri 2023-05-20 20:19

Design for the EMA ryraman2661 2023-05-15 13:03 [Regulatives / Guidelines]
- BE for the EMA Helmut 2023-05-15 13:40
  - BE for the EMA ryraman2661 2023-05-16 08:04
  - BE for the EMA Ohlbe 2023-05-16 08:51

R Validation Imph 2023-05-14 13:48 [Power / Sample Size]
- R Validation Helmut 2023-05-15 11:54
  - R Validation Imph 2023-05-15 13:35
    - R Validation Helmut 2023-05-15 13:42

Gender Effect on Clarithromycin Neera 2023-05-15 09:24 [Regulatives / Guidelines]

Inclusion criteria in BE studies Loky do 2020-05-22 18:16 [Design Issues]
- BE: ♀♂ Helmut 2020-05-23 17:12
- Inclusion criteria in BE studies jag009 2020-05-25 07:43
  - Stratify for sex? Helmut 2020-05-25 12:48
    - Stratify for sex? jag009 2020-05-25 21:10
- Inclusion criteria in BE studies ElMaestro 2020-05-25 14:39
  - Inclusion criteria in BE studies Loky do 2020-06-10 13:19
  - Inclusion criteria in BE studies BEQool 2023-05-05 10:42
    - Sex-by-treatment interaction Helmut 2023-05-05 12:44
      - Sex-by-treatment interaction BEQool 2023-05-11 09:12

505 b(2) application & requirement of bioequivalence Mithu 2023-05-04 04:59 [Regulatives / Guidelines]
- 505 b(2) application & requirement of bioequivalence dshah 2023-05-05 13:38
  - 505 b(2) application & requirement of bioequivalence Mithu 2023-05-11 07:58
- 505 b(2) application & requirement of bioequivalence Achievwin 2023-05-05 16:08
  - 505 b(2) application & requirement of bioequivalence Mithu 2023-05-11 07:58

Chile regulatory Pharma_88 2023-05-10 04:19 [Regulatives / Guidelines]

Sample size estimation for parallel design Nav Coelho 2007-07-20 16:14 [Power / Sample Size]
- Parallel designs (total variance) Helmut 2007-07-20 16:29
  - Parallel designs (total variance) Nav Coelho 2007-07-20 18:38
    - CV-intra # 60% CV-inter Helmut 2007-07-22 01:17
    - total (pooled) variance: examples Helmut 2007-07-23 17:44
      - total (pooled) variance: examples Nav Coelho 2007-07-23 19:58
      - total (pooled) variance: examples BEQool 2023-04-18 09:59
        
        Higher-Order Crossovers Helmut 2023-04-20 10:19
        
        Higher-Order Crossovers BEQool 2023-04-21 07:53
        
        total (pooled) variance: examples zizou 2023-04-21 21:23
        
        total (pooled) variance: examples BEQool 2023-04-22 18:20
        
        total (pooled) variance: examples zizou 2023-04-22 21:06
        
        total (pooled) variance: examples BEQool 2023-04-25 10:57
        
        total (pooled) variance: examples zizou 2023-04-25 22:43
        
        total (pooled) variance: examples BEQool 2023-05-04 08:17
- Sample size estimation for parallel design Dipesh Jayswal 2007-07-24 08:52

ABE results from SAS and WinNolin are not matched weiguo2122 2023-04-19 14:43 [Regulatives / Guidelines]
- ABE results from SAS and WinNolin are not matched BEQool 2023-04-20 06:21
- Variable names, lexical order? Helmut 2023-04-20 08:13
  - Variable names, lexical order? PharmCat 2023-04-20 19:58
  - Variable names, lexical order? weiguo2122 2023-04-21 14:15
    - Variable names, lexical order? Helmut 2023-04-21 15:45

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