Bioequivalence and Bioavailability Forum

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

Validation of PhEq_bootstrap Helmut 2018-07-12 17:47 [Software]
- Validation of PhEq_bootstrap ElMaestro 2018-07-12 22:21
  - Validation of PhEq_bootstrap Helmut 2018-07-13 01:29
    - Validation of PhEq_bootstrap ElMaestro 2018-07-13 10:14
      - Validation of PhEq_bootstrap Helmut 2018-07-13 12:54
        
        Validation of PhEq_bootstrap ElMaestro 2018-07-13 14:28
- Validation of PhEq_bootstrap Shuanghe 2018-07-17 15:54
- PhEq_bootstrap in R d_labes 2018-08-15 09:45
  - bootf2BCA v1.2 Helmut 2019-10-05 00:59
    - bootf2BCA v1.2: seed Helmut 2020-09-25 19:37
      - bootf2BCA v1.2: seed PTM139 2021-04-16 07:53
        
        Which packages, working drectory? Helmut 2021-04-16 10:50

Retention samples vinodvasala 2021-04-13 13:27 [Regulatives / Guidelines]
- Retention samples dshah 2021-04-13 19:07

Cataplasms and study design Pharma_88 2021-04-13 06:31 [Regulatives / Guidelines]

WHO guideline on data integrity Ohlbe 2021-04-08 11:03 [Regulatives / Guidelines]

New software for PK analysis - PKMP. Any good ? WhiteCoatWriter 2021-04-02 06:37 [Software]
- New software for PK analysis - PKMP. Any good ? dshah 2021-04-08 05:42

ICH GCP type of the data Beholder 2021-04-05 11:56 [GxP / QC / QA]
- ICH GCP type of the data ElMaestro 2021-04-05 21:35

Exclusion due to adverse event Loky do 2021-03-29 15:59 [Design Issues]
- State it in the SAP & observe it Helmut 2021-03-29 18:08
- Exclusion due to adverse event dshah 2021-03-31 14:43

BE study designing related doubts gsrao2022 2021-03-28 20:12 [Design Issues]
- BE study designing related doubts Helmut 2021-03-29 00:41

Regulations about bioequivalence studies in Turkey Mohamed Yehia 2021-02-22 17:32 [Regulatives / Guidelines]
- Regulations about bioequivalence studies in Turkey akif 2021-03-23 06:46
  - Regulations about bioequivalence studies in Turkey Mohamed Yehia 2021-03-28 16:36

Why is just Cmax out of specification? akif 2021-03-22 20:36 [PK / PD]
- AUC passes, Cmax fails: biopharmaceutical difference Helmut 2021-03-23 11:03
  - AUC passes, Cmax fails: biopharmaceutical difference akif 2021-03-24 16:59

Regulatory Submission in Europe in Absence of Reference product Abhay Patil 2021-03-23 08:58 [Regulatives / Guidelines]
- Regulatory Submission in Europe in Absence of Reference product dshah 2021-03-23 09:51
  - Regulatory Submission in Europe in Absence of Reference product Abhay Patil 2021-03-23 10:00

Question raised by the PMDA Helmut 2021-02-26 15:46 [Design Issues]
- Question raised by the PMDA Ben 2021-03-19 15:47
  - Question raised by the PMDA Helmut 2021-03-19 18:06

List of reference drug Elzbieta 2021-03-15 19:56 [Study Performance]
- List of reference drug dshah 2021-03-16 06:15
- List of reference drug Helmut 2021-03-16 16:33

higher order crossover methodology sweiner 2020-06-30 01:07 [General Statistics]
- All dosed subjects have to be analyzed Helmut 2020-06-30 12:19
  - All dosed subjects have to be analyzed sweiner 2020-06-30 17:08
  - All dosed subjects have to be analyzed sedhosen 2021-03-16 08:30
    - All dosed subjects have to be analyzed Helmut 2021-03-16 16:00
- higher order crossover methodology Relaxation 2020-06-30 14:10
  - higher order crossover methodology sweiner 2020-06-30 17:10
    - higher order crossover methodology ElMaestro 2020-06-30 18:17
      - Fed (IBD) → fasting Helmut 2020-07-01 11:14
        
        Fed (IBD) → fasting sweiner 2020-07-07 03:00

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There is one certainty in drug development
and statistics that one can depend on:
the data are always late. Scott Patterson and Byron Jones

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Ing. Helmut Schütz