Bioequivalence and Bioavailability Forum

Sample Size Estimation in Bioequivalence 💯 Helmut 2020-05-20 22:39 [Surveys]📌
- Evaluation ☑️ Helmut 2020-06-03 12:36

⚠️ Read before registering Helmut 2016-04-14 23:39 [Tips / Tricks]📌

Is Cmax 95% Upper bound 0.0024.= Zero? Sereng 2020-10-22 20:30 [RSABE / ABEL]

Thailand FDA Bioequivalence Guideline Pharma_88 2020-10-22 06:49 [Regulatives / Guidelines]
- Thailand FDA Bioequivalence Guideline Brus 2020-10-22 09:16

bear: it's time to say goodbye yjlee168 2020-10-20 09:53 [R for BE/BA]
- So sad! Helmut 2020-10-20 11:30
  - So sad! yjlee168 2020-10-20 13:39
    - THX! Helmut 2020-10-20 13:58
- bear: it's time to say goodbye krish85 2020-10-20 13:01
  - bear: it's time to say goodbye yjlee168 2020-10-20 13:43
    - bear: it's time to say goodbye Astea 2020-10-21 14:36
      - Thanks! yjlee168 2020-10-21 20:07

Russia BE Study Anand 2015-03-27 05:28 [Regulatives / Guidelines]
- 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

Data manipulation / fraud in BE ElMaestro 2020-10-21 09:56 [Study Assessment]

Multiple dose design Sample size Researcher101 2020-10-14 10:21 [Power / Sample Size]
- CV of Css,max ≤ CV of Cmax Helmut 2020-10-14 11:27
- Multiple dose design Sample size Researcher101 2020-10-14 13:37
  - Sample size based on worst case Helmut 2020-10-19 16:17
  - Multiple dose design Sample size dshah 2020-10-20 06:43

Au sujet de la conservation du plasma frais congelé vierge Developper bioanalyste 2020-10-14 16:33 [Bioanalytics]
- Conservation du plasma frais congelé vierge - storage of blank plasma Ohlbe 2020-10-14 23:37
  - OT: Preferred language in the forum Helmut 2020-10-15 00:40
    - OT: Preferred language in the forum yjlee168 2020-10-15 01:50
      - OT: Preferred language in the forum Helmut 2020-10-15 11:37
    - OT: Preferred language in the forum ElMaestro 2020-10-15 08:19
      - OT: Preferred language in the forum Helmut 2020-10-15 12:02
    - Just to annoy Helmut jag009 2020-10-19 19:52
      - Easy, Fritz! Helmut 2020-10-19 20:42

Sample size for NTI using FDA method by excel macro dshah 2020-10-16 06:20 [Power / Sample Size]
- Sample size for NTI using FDA method by excel macro d_labes 2020-10-16 11:09
  - Sample size for NTI using FDA method by excel macro dshah 2020-10-16 12:11
- Simulating studies in Excel not possible Helmut 2020-10-16 11:11
  - Simulating studies in Excel not possible dshah 2020-10-16 12:12
    - Simulating studies in Excel not possible martin 2020-10-16 12:52
      - Simulating studies in Excel not possible dshah 2020-10-20 06:59
  - may be possible -> Simulating studies in Excel not possible yjlee168 2020-10-17 08:09
    - Simulating studies in Excel possible but slow 🐌 Helmut 2020-10-17 11:30
      - Have you upgraded to R v4.0.3 yet? yjlee168 2020-10-19 02:16
        
        Run on R v4.0.3 Helmut 2020-10-19 12:12

FARTSSIE v2.5 Helmut 2020-10-18 11:09 [Software]

Retention period and quantity for Malaysian submission Sriramprasad 2020-07-18 09:06 [Regulatives / Guidelines]
- 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

Linear and Non-linear pharmacokinetics Sridhar.E 2020-10-08 12:23 [PK / PD]
- Linear and Non-linear pharmacokinetics ElMaestro 2020-10-08 13:13
  - Linear and Non-linear pharmacokinetics Sridhar.E 2020-10-08 13:23
- Linear and Non-linear pharmacokinetics Helmut 2020-10-08 13:44
- Linear and Non-linear pharmacokinetics martin 2020-10-16 08:34
  - OT: The Wild Bunch Helmut 2020-10-16 15:38

bioequivalence criteria for NTID Biostats 2018-03-29 12:39 [Regulatives / Guidelines]
- 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

Parallel design from crossover CV arl_stat 2020-10-14 06:39 [Power / Sample Size]
- No relationship between inter- and intra-subject CV Helmut 2020-10-14 11:00
  - No relationship between inter- and intra-subject CV arl_stat 2020-10-14 15:02

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