Bioequivalence and Bioavailability Forum

Biowaiver for lower strength using different OGD media dshah 2020-07-13 08:09
- EMA: No biowaivers for NTIDs Helmut 2020-07-15 19:08
  - EMA: No biowaivers for NTIDs Relaxation 2020-07-16 10:54
    - Biowaiver only for BCS I and – under certain conditions – BCS III drugs Helmut 2020-07-16 11:27
      - Biowaiver only for BCS I and – under certain conditions – BCS III drugs Obinoscopy 2020-07-16 14:36
        
        Biowaiver only for BCS I and – under certain conditions – BCS III drugs dshah 2020-07-17 06:27
        
        Additional Strength Biowaiver Requirements Obinoscopy 2020-07-18 03:13
        Additional strength Biowaiver wienui 2020-07-18 18:00

how to use Loo Riegelman method and deconvolution laili 2012-05-07 09:40
- how to use Loo Riegelman method and deconvolution SDavis 2012-05-18 12:32
- how to use Loo Riegelman method and deconvolution vjkumar 2012-08-23 12:03
  - how to use Loo Riegelman method and deconvolution Gobardhan 2020-07-16 13:31

Weibull method for Dissolution Similarlies Jainee 2020-04-30 18:10
- Weibull method for Dissolution Similarlies yjlee168 2020-04-30 18:31
  - Weibull method for Dissolution Similarlies Nirali 2020-05-01 07:37
- Weibull method for Dissolution Similarlies Achievwin 2020-05-07 03:49
  - Weibull method for Dissolution Similarlies Jainee 2020-05-10 11:35

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

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

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

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

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