Bioequivalence and Bioavailability Forum

PASS Sample Size - Rosy, 2019-01-21 17:37

"Annex III: To procedure for (...)": I am so confused :-) - ElMaestro, 2019-01-17 17:18
- "Annex III: To procedure for (...)": I am so confused :-) - nobody, 2019-01-17 17:41
- Bonus questions - ElMaestro, 2019-01-17 18:25
  - Bonus questions - nobody, 2019-01-17 19:00
  - Bonus questions - Ohlbe, 2019-01-18 21:26
- "Annex III: To procedure for (...)": I am so confused :-) - Ohlbe, 2019-01-18 21:05

EMA guideline - Trial Master File - suchit_bhavsar, 2018-12-19 06:09

AUCt not covering at least 80% of AUCinf - ratnakar1811, 2013-03-05 08:30
- AUCt not covering at least 80% of AUCinf - d_labes, 2013-03-05 11:12
  - AUCt not covering at least 80% of AUCinf - ratnakar1811, 2013-03-06 08:50
    - AUCt not covering at least 80% of AUCinf - ElMaestro, 2013-03-06 11:10
      - ADME-tox? - Helmut, 2013-03-06 14:35
        
        ADME-tox? - ElMaestro, 2013-03-06 16:40
        
        OT - Helmut, 2013-03-06 17:19
        
        OT - ElMaestro, 2013-03-07 17:19
        
        OT - Helmut, 2013-03-07 17:26
    - Science vs. regulations - Helmut, 2013-03-06 14:30
      - Science vs. regulations - cakhatri, 2013-03-10 08:59
        
        ratio = difference of logs! - Helmut, 2013-03-11 01:17
      - Science vs. (EMA) GL aka PK primer - Helmut, 2013-03-11 03:17
    - AUCt not covering at least 80% of AUCinf - Brus, 2018-11-20 13:01

Diclofenac Potassium Powder for Oral Solution - Ahmed Al Habashi, 2014-08-16 07:08
- Diclofenac Potassium Powder for Oral Solution - Dr_Dan, 2014-08-16 09:47
  - Diclofenac Potassium Powder for Oral Solution - Helmut, 2014-08-16 13:00
    - Diclofenac Potassium Powder for Oral Solution - mayur661, 2018-11-16 09:02
      - Diclofenac Potassium Powder for Oral Solution - Ohlbe, 2018-11-16 10:01
        
        Diclofenac Potassium Powder for Oral Solution - mayur661, 2018-11-16 10:08
        
        Fasting and fed - Ohlbe, 2018-11-16 12:09
        
        Fasting and fed - mayur661, 2018-11-16 12:27

Body mass index - priyanka12345, 2018-11-16 08:10
- Body mass index - Ohlbe, 2018-11-16 10:00

Drug-Drug Interactions (DDIs) - Mauricio Sampaio, 2017-10-26 16:25
- Drug-Drug Interactions (DDIs) - Mauricio Sampaio, 2018-11-13 20:07

AB rating & bioequivalence - mayur661, 2018-11-13 09:33
- Forum policy - Ohlbe, 2018-11-13 10:19

T max - Mikalai, 2018-11-09 08:18

Brand drugs for dissolution profile - mercury606, 2018-11-05 10:47

Retention quantity for Turkey Submission study - satishbedada, 2018-11-02 06:11

Clinical significance of Tmax - M.tareq, 2017-10-12 07:53
- Clinical significance of Tmax - Helmut, 2017-10-12 13:22
  - Clinical significance of Tmax - M.tareq, 2017-10-22 00:36
  - Clinical significance of Tmax - kumarnaidu, 2018-11-01 14:01

Morocco guidelines - ananth, 2018-10-31 10:23
- Morocco guidelines - rajasekharkakarla, 2018-11-01 08:05

archival period of Study documents as Per FDA, ANVISA, EMEA guidelines - vivekb2, 2018-10-27 07:59

FDA: Size of bio-batch - Helmut, 2013-12-10 14:05
- FDA: Size of bio-batch - jag009, 2013-12-10 20:03
  - FDA: antique of ’93 - Helmut, 2013-12-10 23:32
    - FDA: antique of ’93 - jag009, 2013-12-11 15:23
      - FDA: antique of ’93 - Helmut, 2013-12-11 15:26
        
        FDA: antique of ’93 - jag009, 2013-12-11 16:21
        
        FDA: antique of ’93 - Helmut, 2013-12-11 16:29
        
        FDA: antique of ’93 - jag009, 2013-12-11 23:16
        
        Patience - Helmut, 2013-12-12 14:34
    - FDA: antique of ’93 - Beholder, 2018-06-21 09:21
      - Nice numbers - Helmut, 2018-06-21 15:05
        
        Nice numbers - Beholder, 2018-06-22 10:33
        
        Type II variation - Helmut, 2018-06-22 15:12
      - Birdsong's third law of BE - ElMaestro, 2018-06-22 10:10
        
        Experience - Beholder, 2018-06-22 11:04
        
        Why, oh why? - Helmut, 2018-06-22 15:17
        
        Sorry for the delay - Beholder, 2018-10-18 09:40

Enoxaparin sodium injection BA BE studies - varsha chungde, 2018-10-08 11:34
- BE of parenterals - Helmut, 2018-10-08 11:53
- Enoxaparin sodium injection BA BE studies - nobody, 2018-10-09 10:42
  - Enoxaparin sodium injection BA BE studies - varsha chungde, 2018-10-10 07:09
- Enoxaparin sodium injection BA BE studies - ElMaestro, 2018-10-09 11:13
  - Enoxaparin sodium injection BA BE studies - varsha chungde, 2018-10-10 07:11

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