Bioequivalence and Bioavailability Forum

Comp in-vitro disso studies for generics in India jag009 2020-03-12 15:41
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-12 19:18
  - Comp in-vitro disso studies for generics in India jag009 2020-03-13 17:34
    - Comp in-vitro disso studies for generics in India ping4santosh 2020-03-14 23:20
      - Comp in-vitro disso studies for generics in India jag009 2020-03-15 07:25
        
        Comp in-vitro disso studies for generics in India ping4santosh 2020-03-15 10:05

Glycopyrrolate BCS Class AB661 2020-01-29 10:12
- Glycopyrrolate BCS Class Achievwin 2020-02-04 23:17

Bio-waiver of Sapropterin dihydrochloride powder for oral solution AB661 2019-11-22 17:49
- Please do your homework first Helmut 2019-11-24 10:51
- Bio-waiver of Sapropterin dihydrochloride powder for oral solution Achievwin 2019-12-03 17:06

Dissolution Testing Requirement - ANDA jag009 2019-10-30 02:29

If method doesn't exist in FDA Disso Database jag009 2019-10-24 20:54
- USP should be fine Helmut 2019-10-25 00:33
  - USP should be fine jag009 2019-10-30 02:23

EMA: Mahalanobis distance is dead... Helmut 2018-11-09 18:01
- EMA: Mahalanobis distance is dead... ElMaestro 2018-11-09 19:12
  - Is ƒ2 dead as well – always bootstrapping? Helmut 2019-10-06 15:27
    - Is ƒ2 dead as well – always bootstrapping? ElMaestro 2019-10-06 17:54
      - Ahem – number of units? Helmut 2019-10-06 18:14
        
        Ahem – number of units? ElMaestro 2019-10-06 22:45
        
        Ahem – number of units? wienui 2019-10-07 19:11

Dissolution Media for Comparative Dissolution Study ilee9009 2019-09-20 11:00

predicting in vivo PK profiles from in vitro data after establishing IVIVC amer 2019-09-09 05:04
- external predictability for ivivc yjlee168 2019-09-09 10:46
  - external predictability for ivivc amer 2019-09-10 02:31
    - identical pH Helmut 2019-09-10 10:58
      - identical pH yjlee168 2019-09-10 15:30
    - R scripts/codes for in-vivo conc. yjlee168 2019-09-10 15:13
      - Software validation, another round Helmut 2019-09-10 15:37
        
        Deconvolution mittyri 2019-09-10 15:54
        Software validation, another round yjlee168 2019-09-11 10:29
        
        Software validation, another round Helmut 2019-09-11 13:39
        
        Software validation, another round amer 2019-09-12 05:26
        
        Should we also consider to validate the validation? yjlee168 2019-09-12 09:46
        
        Who inspects the inspectors? Helmut 2019-09-13 12:07
        
        Who inspects the inspectors? nobody 2019-09-13 12:55
        
        Sapienti sat Helmut 2019-09-13 12:59
      - R scripts/codes for in-vivo conc. amer 2019-09-11 05:35
        
        Bioavailabity term in predicted in-vivo conc. yjlee168 2019-09-11 10:16

Biorelevant Dissolution - FeSSGF with Ensure Plus thalita_m 2019-07-26 15:55

BSC approach at each strength? Mauricio Sampaio 2019-07-19 22:29
- BSC approach at each strength? jag009 2019-07-22 19:56
  - BSC approach at each strength? Mauricio Sampaio 2019-07-22 21:43
    - BSC approach at each strength? Ohlbe 2019-07-22 23:58
      - BSC approach at each strength? Mauricio Sampaio 2019-07-23 04:48
        
        BCS approach at each strength? Mauricio Sampaio 2019-07-26 15:32

Statistical comparison of dissolution profiles - variable nr of units MSimoes 2019-07-17 18:13
- Statistical comparison of dissolution profiles - variable nr of units ElMaestro 2019-07-17 21:02
  - Statistical comparison of dissolution profiles - variable nr of units MSimoes 2019-07-18 10:22
- EU: No Mahalanobis Helmut 2019-07-18 13:06

Virtual Bioequivalence: a myth or coming reality? mittyri 2018-06-09 22:39
- Virtual Bioequivalence: a myth or coming reality? jag009 2018-06-13 02:40
- Virtual Bioequivalence: a myth or coming reality? elba.romero 2018-10-19 01:17
- Virtual Bioequivalence: an update from PAGE (+TSD!) mittyri 2019-06-21 13:50
  - FDA not concerned about the type I error? Helmut 2019-06-22 18:11

IVIVC with Bioequivalence Data thalita_m 2019-06-18 01:55
- IVIVC or not IVIVC? yjlee168 2019-06-18 20:57
  - IVIVC or not IVIVC? thalita_m 2019-06-20 22:40
- Get Fabs if no iv data... yjlee168 2019-06-19 09:36

IVIVC calculations mahendra 2013-10-24 16:10
- IVIVC calculations yjlee168 2013-10-24 19:22
  - IVIVC calculations mahendra 2013-10-24 19:45
    - IVIVC calculations yjlee168 2013-10-24 22:21
      - Mergers Helmut 2013-10-25 14:38
      - IVIVC calculations mahendra 2013-10-25 16:49
        
        PCDCON ⇒ IVIVC calculations yjlee168 2013-10-27 05:41
      - IVIVC calculations thalita_m 2019-06-18 02:51
- IVIVC calculations jag009 2013-10-24 23:17
  - Minitab etc. Helmut 2013-10-25 14:43
    - Minitab etc. jag009 2013-10-25 16:27
      - XL Helmut 2013-10-25 16:38
        
        XL jag009 2013-10-28 20:42
        
        XL luvblooms 2013-10-29 05:08
        
        XL jag009 2013-10-29 15:07
        
        XL luvblooms 2013-10-30 07:00
        
        Broken link Helmut 2013-10-30 14:40
        XL jag009 2013-10-30 16:35
        
        XL luvblooms 2013-10-31 08:15
        
        XL jag009 2013-10-31 20:31
        Any news? jag009 2013-11-06 16:44
        
        Good News luvblooms 2013-11-07 10:50
        
        PBPK IVIVC jag009 2013-11-27 16:44
        
        PBPK IVIVC luvblooms 2013-11-27 19:31
        
        PBPK IVIVC jag009 2013-11-27 20:04
        
        Good News jag009 2013-11-28 06:01
        
        Contact Helmut 2013-11-07 14:50
        
        Contact jag009 2013-11-27 16:42
        
        XL thalita_m 2019-06-18 02:46
        
        Jean-Michel Helmut 2019-06-18 11:08
        
        Jean-Michel thalita_m 2019-06-20 22:18
  - IVIVC calculations mahendra 2013-10-25 16:48
- IVIVC calculations vinayshed 2013-10-28 08:54

Is FDA dissolution database more preferable to product specific FDA BE guidance? yuvaneshwari 2019-04-18 11:12
- Is FDA dissolution database more preferable to product specific FDA BE guidance? Vineeth KE 2019-04-25 13:15