Bioequivalence and Bioavailability Forum

ICHM13/High risk products Mikkabel 2024-11-20 09:00 [Regulatives / Guidelines]
- ICHM13/High risk products Helmut 2024-11-21 09:23
  - ICHM13/High risk products Mikkabel 2024-11-21 10:38
    - ICHM13/High risk products Ohlbe 2024-11-21 11:49
      - ICHM13/High risk products Mikkabel 2024-11-21 15:26
        
        ICHM13/High risk products Ohlbe 2024-11-22 10:51
        
        Generic vs. hybrid Helmut 2024-11-22 13:17

Baseline correction vs non-baseline correction jag009 2015-09-15 20:29 [Regulatives / Guidelines]
- Baseline correction vs non-baseline correction Lucas 2015-09-16 14:16
  - Baseline correction vs non-baseline correction Relaxation 2015-09-18 10:25
- Baseline correction or supra-therapeutic dose Helmut 2015-09-16 15:16
  - Baseline correction or supra-therapeutic dose Ohlbe 2015-09-16 17:55
    - Baseline profile prior to each period? Helmut 2015-09-16 18:15
    - Baseline correction examples Helmut 2015-09-17 15:44
      - Baseline correction examples Lucas 2015-09-18 14:19
        
        Baseline correction examples Helmut 2015-09-18 17:28
        
        Baseline correction examples Mauricio Sampaio 2016-02-07 03:05
        
        Baseline correction examples Lucas 2016-02-10 11:48
        
        Postmenopausal women Helmut 2016-02-10 12:26
        Baseline correction examples Mauricio Sampaio 2016-02-11 01:38
        Baseline correction examples Dr_Dan 2016-02-11 09:22
        
        Postmenopausal women Mauricio Sampaio 2016-02-12 03:24
        
        Postmenopausal women Dr_Dan 2016-02-15 17:45
        
        Baseline correction examples BEQool 2024-11-11 07:34
        
        Baseline correction GeoMean and Median mittyri 2024-11-11 11:20
        
        Geometric mean? Helmut 2024-11-11 14:53
        
        Geometric mean? BEQool 2024-11-14 08:19
        
        Geometric mean ≈ MLE of median Helmut 2024-11-14 09:54
        
        Geometric mean ≈ MLE of median Mahmoud 2024-11-15 11:26
        
        Bias? Helmut 2024-11-16 08:43
        
        Bias? Mahmoud 2024-11-16 11:12
    - Baseline; another example Helmut 2015-09-18 17:16
      - Baseline; another example nobody 2016-02-12 09:10
        
        Baseline; another example Helmut 2016-02-12 13:37
        
        Baseline; another example nobody 2016-02-12 14:08
        
        Slowly going OT: BE study simulations Helmut 2016-02-12 15:47
        
        Slowly going OT: BE study simulations nobody 2016-02-12 16:15
        
        Religious debate Helmut 2016-02-12 17:04
        
        Religious debate nobody 2016-02-12 17:26
        
        Religious debate ElMaestro 2016-02-13 12:53
        
        Religious debate nobody 2016-02-14 15:23
        
        Slowly going OT: BE study simulations Ohlbe 2016-02-13 13:10
        
        Slowly going OT: BE study simulations Helmut 2016-02-13 15:02
        
        Slowly going OT: BE study simulations lizhao 2016-02-25 17:31
        
        Business as usual Helmut 2016-02-25 17:44
        
        Business as usual lizhao 2016-02-25 17:59

reason to exclude volunteer Loky do 2024-11-10 11:52 [Study Assessment]
- FDC: No measurable concentrations of one drug Helmut 2024-11-10 12:33
  - FDC: No measurable concentrations of one drug Loky do 2024-11-10 12:48

Calculating 90% CIs in R vs Python Dorota_ 2024-11-08 18:35 [Software]

‘alpha’ of scaled ABE? d_labes 2013-03-15 15:56 [RSABE / ABEL]
- ‘alpha’ of scaled ABE? Helmut 2013-03-15 17:27
  - ’alpha’ of scaled ABE: design d_labes 2013-03-16 20:10
    - N=24, 48 d_labes 2013-03-18 08:11
      - adaptive design without adjustment martin 2013-03-25 20:47
        
        α adjustment? Helmut 2013-03-26 15:21
        
        iteratively adjusted alpha martin 2013-03-26 16:19
        
        throw away our sample size tables? Helmut 2013-03-26 18:02
        
        if real martin 2013-03-26 19:44
        
        regulators don’t care? Helmut 2013-03-26 21:18
        
        adjusting α Helmut 2013-08-11 16:19
        
        missing letter apapanas 2024-10-31 06:02
        
        PowerTOST: sampleN.scABEL.ad() Helmut 2024-10-31 08:41
        
        PowerTOST: sampleN.scABEL.ad() apapanas 2024-11-08 10:48
        
        Molins et al. (2017) Helmut 2024-11-08 14:34
        
        target α in sim’s? Helmut 2013-03-27 15:38
        
        target α in sim’s? martin 2013-03-27 16:36
        
        If it is real: results Helmut 2013-03-28 23:20
        
        having alpha martin 2013-03-28 15:08
        
        fixed swr Helmut 2013-03-28 23:34
        
        fixed swr martin 2013-03-29 15:07
        
        Yes but no but yes but no but… Helmut 2013-03-29 16:10

Shipment of Investigational Medicinal products qualityassurance 2024-10-30 13:47 [Regulatives / Guidelines]
- Shipment of Investigational Medicinal products Ohlbe 2024-11-05 22:11
  - Shipment of Investigational Medicinal products qualityassurance 2024-11-06 14:15

Reanalysis reason Loky do 2024-11-04 11:15 [Bioanalytics]
- Daylight saving time Helmut 2024-11-04 11:49
  - Daylight saving time Loky do 2024-11-04 15:37

FDA: Update of PSGs to align with ICH M13A Helmut 2024-10-03 15:58 [Regulatives / Guidelines]
- FDA: ICH M13A, Q&A, PSGs, and a rant Helmut 2024-11-01 08:58

PK Sampling Time Points - SR Formulation TitusBen 2024-10-17 05:40 [Design Issues]
- PK Sampling Time Points - SR Formulation Helmut 2024-10-17 10:56
  - PK Sampling Time Points - SR Formulation TitusBen 2024-10-18 06:24
    - PK Sampling Time Points - DR Formulation Helmut 2024-10-18 09:16
      - PK Sampling Time Points - DR Formulation TitusBen 2024-10-18 16:45
        
        lag-time – another round Helmut 2024-10-19 08:20

Question about computing 90% CI w data from 2 separate studies jag009 2024-10-14 01:44 [General Statistics]
- Question about computing 90% CI w data from 2 separate studies dshah 2024-10-14 08:38
  - Question about computing 90% CI w data from 2 separate studies jag009 2024-10-14 15:40
- Question about computing 90% CI w data from 2 separate studies BEQool 2024-10-14 11:37
  - Question about computing 90% CI w data from 2 separate studies jag009 2024-10-14 15:45
    - Question about computing 90% CI w data from 2 separate studies BEQool 2024-10-18 12:03
  - Question about computing 90% CI w data from 2 separate studies dshah 2024-10-15 06:11

Bioequivalence centre and In vitro (formulation lab) ryraman2661 2024-10-18 11:14 [Dissolution / BCS / IVIVC]

Sulfasalazine: Bioequivalence Study ramesh_7779 2011-06-25 10:54 [Design Issues]
- Sulfasalazine: Bioequivalence Study Helmut 2011-06-25 13:18
  - Sulfasalazine: Bioequivalence Study dshah 2024-10-15 06:05
    - Sulfasalazine: Sources Helmut 2024-10-15 09:03
      - Sulfasalazine: Sources dshah 2024-10-16 06:16

"Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 01:14 [Regulatives / Guidelines]
- "Dose or Strength to be Studied" in ICH M13A BEQool 2024-10-07 10:33
  - "Dose or Strength to be Studied" in ICH M13A Darborn 2024-10-08 00:58

Draft guideline on quality and equivalence of topical products – still stuck? mittyri 2024-09-14 20:24 [Regulatives / Guidelines]
- Patience… Helmut 2024-09-18 08:22
  - MWP Ohlbe 2024-09-18 10:26
    - Final & published Helmut 2024-10-03 11:44

EMA: GL on quality and equivalence of LALA cutaneous products Helmut 2024-10-03 11:41 [BE/BA News]