Bioequivalence and Bioavailability Forum

multilayer tablet exclusion criteria from PK analysis due to emesis Mahesh M 2016-01-08 10:56
- multilayer tablet exclusion criteria from PK analysis due to emesis Mahesh M 2016-01-13 12:46
  - multilayer tablet exclusion criteria from PK analysis due to emesis jag009 2016-01-26 17:56
    - tmax IR > tmax MR? Dr_Dan 2016-01-28 08:57
      - tmax IR > tmax MR? jag009 2016-01-29 22:51
- multilayer tablet exclusion criteria from PK analysis due to emesis Shuanghe 2016-01-28 13:00
  - multilayer tablet exclusion criteria from PK analysis due to emesis jag009 2016-01-29 23:02
    - multilayer tablet exclusion criteria from PK analysis due to emesis Shuanghe 2016-02-01 11:01
      - multilayer tablet exclusion criteria from PK analysis due to emesis Mahesh M 2016-02-01 13:14

Regarding regulatory acceptability of Pilot study data as submission study kumarnaidu 2016-01-28 09:58
- Regarding regulatory acceptability of Pilot study data as submission study ElMaestro 2016-01-29 00:07

Newly Added Recommendations since December 31, 2015 (35 New; 12 Revisions) Mahesh M 2016-01-28 12:57
- abiraterone: fasting+fed Helmut 2016-01-28 15:10

Bioequivalence Recommendations for Specific Products cr.maroj 2013-09-19 11:00
- Bioequivalence Recommendations for Specific Products Ohlbe 2013-09-19 11:45
  - EMA: Draft product-specific guidances ♬ Helmut 2013-11-15 15:45
    - EMA: Draft product-specific guidances ♬ luvblooms 2013-11-19 06:35
    - EMA: Capecitabine product-specific guidance ♬ mittyri 2013-12-10 15:33
      - EMA: Capecitabine product-specific guidance ♬ Helmut 2013-12-10 16:11
        
        Russian GL 2013: harmonisation to EMA mittyri 2013-12-14 11:57
    - EMA: Draft product-specific guidances ♬ pash413 2013-12-18 12:35
      - EMA: Use of AUC72 not dependent on t½ Helmut 2013-12-18 14:35
    - End of consultation approaching‼ Helmut 2014-02-10 18:33
      - End of consultation approaching‼ Dr_Dan 2016-01-28 09:27
        
        Guesstimates Helmut 2016-01-28 13:32
- EMA: generally no product-specific GLs Helmut 2013-09-19 11:48
  - Thank you cr.maroj 2013-09-19 13:03
  - EMA: generally no product-specific GLs The Outlaw Torn 2013-09-20 07:52
    - EMA: parent whenever possible Helmut 2013-09-20 09:02
      - EMA: parent whenever possible cr.maroj 2013-09-20 10:14
        
        EMA: parent whenever possible Helmut 2013-09-20 12:53
        
        EMA: parent whenever possible Ohlbe 2013-09-20 13:52
        
        EMA: parent whenever possible mittyri 2013-09-20 14:55
        
        EMA vs. Russia Helmut 2013-09-20 19:21
        
        FDA: Prasugrel intuitivepharma 2013-12-20 07:36
        
        FDA: Prasugrel Helmut 2013-12-20 13:46
        
        FDA: Prasugrel intuitivepharma 2013-12-24 06:38
        
        FDA: Alternative approaches… Helmut 2013-12-24 14:15
        
        FDA: Alternative approaches… intuitivepharma 2013-12-26 05:11
        
        FDA: RTR Helmut 2013-12-26 14:35
        
        FDA: RTR intuitivepharma 2013-12-31 05:34
        FDA: RTR meghalvakil20 2015-07-23 16:32
        
        WayBack Machine Helmut 2015-07-23 16:58
        
        WayBack Machine meghalvakil20 2015-07-23 17:03
        
        Old stuff Helmut 2015-07-23 17:28
        
        EMA: parent whenever possible ElMaestro 2013-09-20 19:35
        
        EMA: Sirolimus product-specific GL luvblooms 2013-11-19 13:00

Bioequivalence of ODT (Orodispersible Tablets) Dr Ripal 2016-01-01 05:43
- Bioequivalence of ODT (Orodispersible Tablets) drgunasakaran1 2016-01-02 18:52
  - Bioequivalence of ODT (Orodispersible Tablets) Dr Ripal 2016-01-04 09:39
    - Crystal ball Helmut 2016-01-04 16:35
      - Crystal ball Dr Ripal 2016-01-06 08:03

Late phase clinical trial guidelines Thailand Dr Ripal 2015-12-29 12:13

NTI drugs with moderate to high variability arl_stat 2015-12-10 06:53
- NTI drugs with moderate to high variability d_labes 2015-12-10 08:47
  - NTI drugs with moderate to high variability arl_stat 2015-12-14 06:00

Guidance Document for BE Study-Korean Regulatory biopk 2015-11-19 08:14
- Guidance Document for BE Study-Korean Regulatory Helmut 2015-11-20 14:38
  - Guidance Document for BE Study-Korean Regulatory biopk 2015-11-23 04:27
  - Guidance Document for BE Study-Korean Regulatory biopk 2015-11-27 09:42
    - Guidance Document for BE Study-Korean Regulatory bjkim97 2015-12-11 07:12

Product Specific - Magnesium Hydroxide tablets bkrao 2015-12-10 07:41

Different N's for different analytes? ddubins 2007-12-05 16:16
- Different N's for different analytes? Charl 2007-12-06 11:28
- Different N's for different analytes? zizou 2015-12-06 22:47
  - Different N's for different analytes? nobody 2015-12-09 09:13
- Different N's for different analytes d_labes 2015-12-08 09:49

WHO Retention krish 2015-12-08 10:45
- WHO Retention Helmut 2015-12-08 13:12

Difference between tablet and film tablet vivekanand 2012-11-16 11:16
- Difference between tablet and film tablet ElMaestro 2012-11-16 13:24
  - Difference between tablet and film tablet wienui 2015-11-24 18:46
    - Difference between tablet and film tablet ElMaestro 2015-11-24 22:01
      - Difference between tablet and film tablet AngusMcLean 2015-12-03 03:25

FDA BE: Truncate AUC for long half-life drug jag009 2015-11-16 16:28
- FDA BE: Truncate AUC for long half-life drug d_labes 2015-11-16 16:51

New FDC - BE reference products Dr_Dan 2015-11-03 09:27
- New FDC - BE reference products nobody 2015-11-05 15:32
  - New FDC - BE reference products Dr_Dan 2015-11-09 08:48
    - New FDC - BE reference products nobody 2015-11-10 14:01

EMA - Newly published modified release guidance mmw 2015-10-29 11:23
- EMA - Newly published modified release guidance mmw 2015-10-31 13:14