Bioequivalence and Bioavailability Forum

▼ Read before registering ▼ - Helmut, 2016-04-14 23:39 [Tips / Tricks]

BCS Based Biowaiver application Price? - joosefupas, 2018-10-19 14:54 [Dissolution / BCS / IVIVC]

Quality System - vishal1721, 2018-10-19 09:29 [GxP / QC / QA]

Little thing which changes almost everything in EEU - Beholder, 2018-10-18 09:08 [Bioanalytics]
- LLOQ ≤5% of expected or observed Cmax? - Helmut, 2018-10-18 12:28
  - LLOQ ≤5% of average or minimal Cmax? - Beholder, 2018-10-18 13:59
    - LLOQ ≤5% of individual Cmax-values - Helmut, 2018-10-18 18:20
      - LLOQ ≤5% of individual Cmax-values - mittyri, 2018-10-18 19:50
        
        An outlier? - Beholder, 2018-10-19 09:43

Theophylline ER 450 mg study design - Ramesh Ramalingam, 2018-10-18 07:16 [Design Issues]

Reference drug product for Captopril / Hydrochlorothiazide - A-M-R, 2018-10-17 14:46 [Design Issues]

Product-specific advice (steroid nasal sprays) - Mikalai, 2018-10-16 13:42 [Design Issues]
- Product-specific advice (steroid nasal sprays) - ElMaestro, 2018-10-16 20:35
  - Product-specific advice (steroid nasal sprays) - Mikalai, 2018-10-17 09:40
    - Product-specific advice (steroid nasal sprays) - ElMaestro, 2018-10-17 11:56

All animals are equal, but some animals are more equal than others - Helmut, 2018-10-09 14:33 [BE/BA News]

Redesign of the EMA’s website - Helmut, 2018-10-08 12:20 [BE/BA News]

Enoxaparin sodium injection BA BE studies - varsha chungde, 2018-10-08 11:34 [Regulatives / Guidelines]
- 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

Test License - rajasekharkakarla, 2018-10-06 08:05 [Regulatives / Guidelines]
- Test License - Obinoscopy, 2018-10-06 12:58
- Test License - wienui, 2018-10-07 21:04

Retention of BA/BE samples - Neelu Singh, 2018-10-05 06:57 [Regulatives / Guidelines]

Subject exclusion - Mohamed Yehia, 2018-10-02 21:25 [Outliers]
- Subject exclusion - Ohlbe, 2018-10-02 21:30
  - Subject exclusion - Mohamed Yehia, 2018-10-02 21:38
    - Subject exclusion - Ohlbe, 2018-10-02 21:46
      - Subject exclusion - Mohamed Yehia, 2018-10-02 22:18
        
        Subject exclusion - Ohlbe, 2018-10-02 22:35
        
        Subject exclusion - Mohamed Yehia, 2018-10-02 22:45
        
        Subject exclusion - Ohlbe, 2018-10-02 22:51
        
        Subject exclusion - Mohamed Yehia, 2018-10-02 22:55
        
        Subject exclusion - Helmut, 2018-10-02 23:27
        
        Subject exclusion - Mohamed Yehia, 2018-10-02 23:51
        
        Subject exclusion - Helmut, 2018-10-03 23:47

FDA Recommendation on Matrix Effect Determination in CC Assay - Obinoscopy, 2018-10-01 14:38 [Bioanalytics]
- FDA Recommendation on Matrix Effect Determination in CC Assay - Ohlbe, 2018-10-01 15:30
  - FDA Recommendation on Matrix Effect Determination in CC Assay - ElMaestro, 2018-10-01 16:30
    - Reducing matrix effects - Ohlbe, 2018-10-01 17:20

Solubility based Biowaiver - Amalia, 2018-10-01 11:04 [Dissolution / BCS / IVIVC]
- Solubility based Biowaiver - Obinoscopy, 2018-10-01 15:03
  - Solubility based Biowaiver - Amalia, 2018-10-01 15:59
    - Solubility based Biowaiver - Obinoscopy, 2018-10-01 19:05
      - Solubility based Biowaiver - wienui, 2018-10-02 04:52
      - Solubility based Biowaiver - Amalia, 2018-10-02 08:59
        
        Solubility based Biowaiver - The Outlaw Torn, 2018-10-02 09:51
        
        Solubility based Biowaiver - Amalia, 2018-10-02 10:35
        
        Solubility based Biowaiver - Obinoscopy, 2018-10-06 19:59
    - Solubility based Biowaiver - The Outlaw Torn, 2018-10-02 08:56
- Solubility based Biowaiver - lukamar, 2018-10-05 09:30

Error in bear - tshianza, 2018-09-28 08:16 [R for BE/BA]
- Error in bear - yjlee168, 2018-09-28 09:49

Bioequivalence and Bioavailability Forum | Admin contact
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To propose that poor design can be corrected by subtle analysis techniques
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