Bioequivalence and Bioavailability Forum

SUPAC level 3 changes for MR formulations Mithu 2019-09-30 07:42
- SUPAC level 3 changes for MR formulations jag009 2019-10-22 21:31
  - SUPAC level 3 changes for MR formulations Mithu 2019-10-23 09:21
    - SUPAC level 3 changes for MR formulations jag009 2019-10-24 05:34

12 units from 12 different bottles should be used - Dissolution for Suspensions bharathi 2019-09-26 12:20
- 12 units from 12 different bottles should be used - Dissolution for Suspensions jag009 2019-10-22 21:29

Ezetimibe BE Mutasim 2019-09-23 14:40
- Ezetimibe BE Helmut 2019-09-23 15:36
- Confusing guidance Helmut 2019-09-25 11:52
  - Confusing guidance nobody 2019-09-25 13:36
- Ezetimibe final guidance Helmut 2019-09-28 12:11
  - Ezetimibe final guidance Ohlbe 2019-09-30 11:03
    - Ezetimibe final guidance Helmut 2019-09-30 15:33
- Ezetimibe BE ElMaestro 2019-09-30 13:12
  - Ezetimibe BE Helmut 2019-09-30 15:26

0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 19:34
- 0 hr Pre-dose concentration but less than 5% of Cmax Helmut 2012-03-29 19:50
  - 0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 20:10
    - Reanalysis if possible Helmut 2012-03-29 23:17
      - Reanalysis if possible jag009 2012-03-30 15:06
        
        >6 sources of matrix Helmut 2012-03-30 15:16
        
        >6 sources of matrix jag009 2012-03-30 20:40
        
        >6 sources of matrix Helmut 2012-03-31 00:23
        
        >6 sources of matrix jag009 2012-04-04 16:32
        
        Flashback Helmut 2012-04-05 16:10
        
        Flashback jag009 2012-04-05 17:51
        
        No correction if ≤5% Cmax Helmut 2012-04-05 18:08
        
        No correction if ≤5% Cmax navoday 2012-08-15 20:37
        
        excluded period(s) Helmut 2012-08-16 16:36
        
        excluded period(s) rajasekharkakarla 2019-09-20 07:57

Reference replicated designs rajasekharkakarla 2019-09-20 06:35

BA/BE for guidelines for ANVISA in English version Pandu 2019-09-10 05:30
- ANVISA Helmut 2019-09-10 11:25

China Local BE study waiver Ajit Thorat 2019-08-29 09:26
- China BE study Helmut 2019-08-29 10:34
  - China BE study Shuanghe 2019-09-04 15:15

Proportional or non proportional products Mithu 2019-08-27 07:18

Outlier test for reference replicate crossover study design abhimanyu 2019-08-13 15:11
- Outlier test for reference replicate crossover study design ElMaestro 2019-08-13 15:28
- Murky waters Helmut 2019-08-13 16:40

Sponsor’s Medical Expert in Bioequivalence Study yatish gosai 2019-08-06 14:29
- What’s a “Sponsor’s Medical Expert”? Helmut 2019-08-07 12:05

Reference Literature Neil 2019-07-25 18:18
- Do your homework first Helmut 2019-07-26 10:42

One fail and one success, should it be accepted? ssussu 2019-07-17 11:45
- One fail and one success, should it be accepted? ElMaestro 2019-07-17 14:33
- One fail and one success, should it be accepted? jag009 2019-07-18 19:14
- One fail and one success, should it be accepted? WhiteCoatWriter 2019-07-23 14:18

IVRT or IVPT BE studies jag009 2019-07-22 22:59

FDA: Date when a product is designated as RS (or RLD) jag009 2019-07-18 19:11
- FDA: Date when a product is designated as RS (or RLD) luvblooms 2019-07-19 12:29
  - OB Annual edition, Current Cumulative Supplement Helmut 2019-07-19 18:24
    - OB Annual edition, Current Cumulative Supplement jag009 2019-07-22 04:16

Baseline sampling NK 2019-06-26 07:25
- Dihydroergotamine Nasal Spray Helmut 2019-06-26 10:10
  - Dihydroergotamine Nasal Spray ElMaestro 2019-06-26 12:47
- Baseline sampling nobody 2019-06-26 10:21

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