Bioequivalence and Bioavailability Forum

Draft Guidance on Budesonide ER Released kumarnaidu 2014-12-15 11:15

EMA: missing documents Helmut 2014-12-11 17:09
- EMA: missing documents nobody 2014-12-11 18:05
  - EMA: missing documents Helmut 2014-12-12 16:01

MDIs formulation Mahesh M 2014-12-11 13:45
- MDIs formulation ElMaestro 2014-12-11 13:54
  - MDIs formulation Mahesh M 2014-12-12 06:57
    - MDIs formulation ElMaestro 2014-12-12 09:36

Draft FDA guidance on Methylphenidate Hydrochloride kumarnaidu 2014-11-10 08:16
- Five PK metrics + S×F interaction Helmut 2014-11-10 13:57
  - Five PK metrics + S×F interaction AngusMcLean 2014-11-11 19:26
    - Phoenix Helmut 2014-11-11 21:05
      - Phoenix AngusMcLean 2014-11-12 19:25
      - Phoenix AngusMcLean 2014-11-21 00:28
  - Five PK metrics + S×F interaction jag009 2014-11-16 03:39
    - Acceptance limit for the upper 95% confidence bound? Helmut 2014-11-17 12:49
      - Acceptance limit for the upper 95% confidence bound? jag009 2014-11-17 17:29
        
        Quoting László Helmut 2014-11-18 03:56
      - Acceptance limit for the upper 95% confidence bound? AngusMcLean 2014-11-19 13:28
  - Five PK metrics + S×F interaction kumarnaidu 2014-12-09 08:36
    - No RSABE Helmut 2014-12-09 13:18
      - No RSABE kumarnaidu 2014-12-09 14:19
        
        No RSABE Helmut 2014-12-09 14:50
- Five PK metrics + S×F interaction drgunasakaran1 2014-11-10 18:29
  - Five PK metrics + S×F interaction jag009 2014-11-11 18:04
  - Five PK metrics + S×F interaction AngusMcLean 2014-11-11 19:22
    - Five PK metrics + S×F interaction jag009 2014-11-11 20:08
      - Tada! jag009 2014-11-13 20:17
        
        Tada! AngusMcLean 2014-11-13 23:06
        
        Tada! nobody 2014-11-19 09:30
        
        Tada! AngusMcLean 2014-11-19 13:42
        
        Tada! nobody 2014-11-19 13:55
        
        ABEL Helmut 2014-11-19 15:44
        
        ABEL nobody 2014-11-19 16:05
        
        ABEL Helmut 2014-11-19 16:59
        
        ABEL nobody 2014-11-19 17:10
        
        ABEL Helmut 2014-11-19 17:16
        
        ABEL AngusMcLean 2014-11-19 17:45
        
        Difficult formulations Helmut 2014-11-19 20:15
        
        Difficult formulations nobody 2014-11-19 21:04
        
        Difficult formulations Helmut 2014-11-19 21:49

REMS Way Forward: FDA New Draft Guidance luvblooms 2014-12-05 08:20

orally inhaled products (OIPs) Mahesh M 2014-12-03 13:10
- orally inhaled products (OIPs) drgunasakaran1 2014-12-03 15:13
- orally inhaled products (OIPs) ElMaestro 2014-12-03 15:45
  - orally inhaled products (OIPs) Mahesh M 2014-12-04 13:52
    - orally inhaled products (OIPs) ElMaestro 2014-12-04 15:40

EMA MR guideline Ohlbe 2014-11-18 22:55
- Published ! Ohlbe 2014-11-27 19:22
  - Published ! kumarnaidu 2014-11-28 06:20
    - Published ! Ohlbe 2014-11-28 09:30
      - In effect 1 June 2015 Helmut 2014-11-28 14:11
        
        In effect 1 June 2015 Ohlbe 2014-11-28 18:29
        
        Accumulation Jay 2014-12-01 11:11
        
        Accumulation nobody 2014-12-01 15:48

Bioanalysis balakotu 2014-11-28 08:26
- Bioanalysis Mahesh M 2014-11-28 08:54
  - Bioanalysis Ohlbe 2014-11-28 14:15
    - Stopping for futility Helmut 2014-11-28 14:21
- Bioanalysis priya 2014-11-28 13:41

GL on the PK and clinical evaluation of MR dosage forms pash413 2014-11-28 13:54

Missing Concentration calculation/estimation rams 2014-11-27 14:18
- Missing Concentration calculation/estimation Dr_Dan 2014-11-27 14:43
- Missing Concentration calculation/estimation Helmut 2014-11-27 14:53

Guideline Health Canada khaoula 2014-11-23 17:35
- Generally no dose-correction Helmut 2014-11-23 17:55
  - Generally no dose-correction khaoula 2014-11-23 18:16

Precision of Analytical Procedure VSL 2014-11-22 16:00

sublingual tablets A-M-R 2013-02-04 08:34
- sublingual tablets The Outlaw Torn 2013-02-04 08:52
- sublingual tablets drgunasakaran1 2013-02-06 08:40
  - sublingual tablets nobody 2014-11-21 11:33

Subject population to be enrolled pash413 2014-11-10 11:23
- Subject population to be enrolled Dr_Dan 2014-11-10 14:52
- Subject population to be enrolled drgunasakaran1 2014-11-10 18:42

FDA released guidance on Circumstances that Constitute Delay drgunasakaran1 2014-11-03 17:18
- Refusing an inspection… Helmut 2014-11-09 12:37