Bioequivalence and Bioavailability Forum

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

Ethics comittee wisdom 2019-04-23 10:43 [Regulatives / Guidelines]

R code for analysis of data from partial replicate design "2x3x3" BE study mahmoud-teaima 2017-06-08 17:45 [R for BE/BA]
- R code for the EMA’s ABEL Helmut 2017-06-10 01:44
  - R code for the EMA’s ABEL mahmoud-teaima 2017-06-10 22:48
    - R code for the EMA’s ABEL Helmut 2017-06-11 01:24
      - R code for the EMA’s ABEL mahmoud-teaima 2017-06-11 03:01
  - R code for the EMA’s ABEL Yura 2017-09-04 21:22
    - R code for the EMA’s ABEL Helmut 2017-09-05 01:55
      - R code for the EMA’s ABEL Yura 2017-09-05 22:21
        
        R code for the EMA’s ABEL Helmut 2017-09-06 14:24
        
        R code for the EMA’s ABEL Yura 2017-09-08 08:54
  - R code for the EMA’s ABEL sschivu 2019-04-22 13:50
    - package replicateBE for R Helmut 2019-04-22 18:46

Expiration of Reference drug during Bioanalysis wienui 2019-04-14 11:51 [Bioanalytics]
- Expiration of Reference drug during Bioanalysis Helmut 2019-04-14 12:56
- Expiration of Reference drug during Bioanalysis jag009 2019-04-15 06:51
- Expiration of Reference drug during Bioanalysis wienui 2019-04-15 20:58
  - Expiration of Reference drug during Bioanalysis Helmut 2019-04-16 13:20
    - Expiration of Reference drug during Bioanalysis wienui 2019-04-18 10:04
      - OT: Regulatory persons d_labes 2019-04-20 20:46

SAS code for the mixed effects model with sequence mistakenly assigned libaiyi 2019-04-19 09:32 [Study Assessment]
- Failure in randomization Helmut 2019-04-19 12:07
  - Real sensitivity mittyri 2019-04-19 16:19
- What is your root cause? ElMaestro 2019-04-19 15:14

Is FDA dissolution database more preferable to product specific FDA BE guidance? yuvaneshwari 2019-04-18 11:12 [Dissolution / BCS / IVIVC]

Metrics for absorption Helmut 2019-04-15 12:08 [NCA / SHAM]
- Metrics for absorption nobody 2019-04-15 12:15
  - Metrics for absorption ElMaestro 2019-04-15 12:23
    - Metrics for absorption nobody 2019-04-15 12:39
  - Metrics for absorption Helmut 2019-04-15 13:02
    - Metrics for absorption nobody 2019-04-15 13:48
      - Metrics for absorption Helmut 2019-04-15 19:31
        
        Metrics for absorption nobody 2019-04-16 09:34
        
        Metrics for absorption nobody 2019-04-16 15:15
        
        Metrics for absorption Helmut 2019-04-16 17:01
        
        Metrics for absorption nobody 2019-04-17 11:15
        
        Simulation framework mittyri 2019-04-17 01:21
        
        Simulation framework Helmut 2019-04-17 13:31
        
        Conclusion mittyri 2019-04-17 15:42
        
        Conclusion & beyond Helmut 2019-04-17 17:05

Non-inferiority Sample Size Estimation sury 2019-04-16 08:44 [Power / Sample Size]
- Non-inferiority Sample Size Estimation Helmut 2019-04-16 16:53
  - Non-inferiority Sample Size Estimation sury 2019-04-17 06:55
    - Read, read, read! Helmut 2019-04-17 10:59

1+1=2 ? nobody 2019-04-15 09:38 [Off Topic]

WHO Questions and Answers: similar biotherapeutic products Helmut 2019-04-15 00:25 [BE/BA News]

Tmax in three treatment, three period, three sequence design libaiyi 2019-04-09 07:15 [Nonparametrics]
- Tmax in three treatment, three period, three sequence design jag009 2019-04-12 18:19
  - Going beyond two periods Helmut 2019-04-12 19:14

Sample Shipment (dry ice) ☣ Helmut 2019-04-10 15:03 [GxP / QC / QA]
- Sample Shipment (dry ice) ☣ jag009 2019-04-12 07:32
  - Sample Shipment (dry ice) ☣ Helmut 2019-04-12 10:08
    - Satisfaction? mittyri 2019-04-12 15:14
      - Satisfaction? Helmut 2019-04-12 18:59

Storage conditions of plasma samples Erol 2019-04-09 11:51 [Bioanalytics]
- Storage conditions of plasma samples Ohlbe 2019-04-10 10:25
  - OT: Free access to the AAPS J Helmut 2019-04-10 10:46
    - OT: Free access to the AAPS J Ohlbe 2019-04-10 11:45
    - OT: Free access to the AAPS J nobody 2019-04-10 12:26
      - Forum internal: ★ Helmut 2019-04-10 15:26
        
        Forum internal: ★ nobody 2019-04-10 15:42
        
        Forum internal: ★ Helmut 2019-04-10 15:57
        
        Forum internal: ★ nobody 2019-04-10 16:10
        
        Forum internal: ★ Helmut 2019-04-10 16:17
        
        Forum internal: ★ nobody 2019-04-10 16:33
        
        Unique statuses mittyri 2019-04-10 16:02
        
        Unique statuses Helmut 2019-04-10 16:16
        
        Unique statuses nobody 2019-04-12 10:43
  - Storage conditions of plasma samples Erol 2019-04-10 20:29

Clinical Endpoint Bioequivalence study sury 2019-04-08 13:29 [Regulatives / Guidelines]
- Clinical Endpoint Bioequivalence study Ohlbe 2019-04-08 15:18
  - Clinical Endpoint Bioequivalence study sury 2019-04-09 06:19
- Scores Helmut 2019-04-08 15:38

Clinical end point acceptance limit PKS 2019-04-05 08:45 [Study Assessment]
- Clinical end point acceptance limit ElMaestro 2019-04-05 08:51
  - Clinical end point acceptance limit nobody 2019-04-05 09:04
  - Clinical end point acceptance limit PKS 2019-04-05 09:17
    - –0.2025 < –0.2, right? Helmut 2019-04-05 10:53

Bioequivalence and Bioavailability Forum | Admin contact
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