Bioequivalence and Bioavailability Forum

BE trial design as partial replicate and two stage Silva 2014-04-17 08:57
- BE trial design as partial replicate and two stage ElMaestro 2014-04-17 09:17
  - BE trial design as partial replicate and two stage Silva 2014-04-17 09:36
    - EMA = PSRPH? Helmut 2014-04-17 15:33

Cmax for enteric coated product Ken Peh 2014-04-13 07:08
- Cmax for enteric coated product ElMaestro 2014-04-13 09:21
- Cmax for enteric coated product jag009 2014-04-14 15:44

Sample size for parallel 3-way Silva 2014-03-28 18:03

Plasma sample storage duration from USFDA perspective Keath 2014-03-24 10:00
- Plasma sample storage duration from USFDA perspective Helmut 2014-03-24 17:10
  - Plasma sample storage duration from USFDA perspective Keath 2014-03-25 05:05
- Plasma sample storage duration from USFDA perspective AngusMcLean 2014-03-26 20:26
  - Plasma sample storage duration from USFDA perspective Keath 2014-03-27 05:18
    - Plasma sample storage duration from USFDA perspective Ohlbe 2014-03-27 10:35

Draft FDA Guidance Dec 2013 pash413 2013-12-04 15:05
- First impressions Helmut 2013-12-04 16:47
  - First impressions nasir 2014-02-14 06:47
- What is Bioequivalence in the US really? ElMaestro 2013-12-07 23:34
  - Site of action vs. systemic circulation Helmut 2013-12-08 02:05
- Draft FDA Guidance Dec 2013 drgunasakaran1 2013-12-08 08:39
  - Two-stage or RSABE Helmut 2013-12-08 13:59
    - Two-stage or RSABE ElMaestro 2013-12-08 14:17
      - Two-stage methods Helmut 2013-12-08 14:44
        
        Two-stage methods ElMaestro 2013-12-08 18:56
    - RSABE Lucas 2014-03-24 17:05
      - RSABE Helmut 2014-03-24 17:25
        
        RSABE Lucas 2014-03-25 13:33
        
        RSABE Helmut 2014-03-25 14:31
        
        RSABE Lucas 2014-03-26 15:19
        
        RSABE Helmut 2014-03-26 15:28
  - Draft FDA Guidance Dec 2013 jag009 2013-12-09 22:31
    - Draft FDA Guidance Dec 2013 kvgreddy06 2014-02-14 16:44
- End of consultation approaching‼ Helmut 2014-02-26 11:32
  - End of consultation approaching‼ wien-ui 2014-03-01 08:05
    - End of consultation approaching‼ Helmut 2014-03-01 20:09
      - End of consultation approaching‼ wien-ui 2014-03-04 10:53

Hypogonadal males Tina 2014-03-25 15:33
- Hypogonadal males drgunasakaran1 2014-03-25 17:24
- Hypogonadal males Helmut 2014-03-25 17:32
- Hypogonadal males Dr_Dan 2014-03-26 08:27
  - Hypogonadal males Tina 2014-03-26 09:20
    - Hypogonadal males nobody 2014-03-26 09:31

In-Vitro study pravin17 2014-03-25 05:34
- In-Vitro study Dr_Dan 2014-03-25 09:10
  - In-Vitro study pravin17 2014-03-25 12:51
    - In-Vitro study Dr_Dan 2014-03-26 08:37

Investigational product destructions of BE studies pravin17 2014-03-19 06:26
- Investigational product destructions of BE studies drgunasakaran1 2014-03-19 14:00
  - Investigational product destructions of BE studies pravin17 2014-03-25 05:25
- Investigational product destructions of BE studies Dr_Dan 2014-03-25 09:15
  - Investigational product destructions of BE studies pravin17 2014-03-26 07:29

GCP certification Irukulla Shravan Kumar 2014-03-25 10:32

Retention of IPs for BE studies for Transdermal Systems Keath 2014-03-18 12:27
- Retention of IPs for BE studies for Transdermal Systems Dr_Dan 2014-03-19 11:43
  - Retention of IPs for BE studies for Transdermal Systems Keath 2014-03-24 09:47

Sprinkle study in IR formulation Compliance 2014-03-19 05:12
- Sprinkle study in IR formulation Mahesh M 2014-03-19 11:35
- Sprinkle study in IR formulation Dr_Dan 2014-03-19 11:51
  - Sprinkle study in IR formulation Compliance 2014-03-20 07:05
    - Sprinkle study in IR formulation jag009 2014-03-20 16:35

Number of tablets - Retention at two different CROs scorp2011 2014-03-18 07:35
- Number of tablets - Retention at two different CROs Dr_Dan 2014-03-18 11:52
  - Number of tablets - Retention at two different CROs scorp2011 2014-03-19 12:30
    - Number of tablets - Retention at two different CROs Ohlbe 2014-03-19 14:12

regulatory requirement for Injection products balakotu 2014-03-18 07:34
- regulatory requirement for Injection products luvblooms 2014-03-19 05:24

ODT vs. IR mittyri 2014-03-08 15:24
- ODT vs. IR jag009 2014-03-10 19:01
- ODT vs. IR Dr_Dan 2014-03-10 19:36
  - ODT vs. IR mittyri 2014-03-14 10:05
- ODT vs. IR fno 2014-03-14 14:51
  - ODT vs. IR Dr_Dan 2014-03-17 10:30
    - ODT vs. IR fno 2014-03-17 12:18

Difference between test and reference nlpati 2013-10-10 13:40
- Assayed content Helmut 2013-10-10 14:46
- Difference between test and reference jag009 2013-10-10 15:19
  - ∆ <5% ⇒ T/R 95% Helmut 2013-10-10 16:08
    - ∆ <5% ⇒ T/R 95% nlpati 2013-10-11 04:37
    - ∆ <5% ⇒ T/R 95% jag009 2013-10-13 21:02
      - Optimism Helmut 2013-10-14 17:50
        
        T/R 90% to 110% for sample size estimation kumarnaidu 2013-11-26 05:36
        
        T/R 110% Helmut 2013-11-30 14:02
        
        T/R 110% kumarnaidu 2013-12-02 05:35
        the basis of T/R in the Protocol mittyri 2014-03-14 08:10
        
        the basis of T/R in the Protocol Helmut 2014-03-14 13:53
        
        the basis of T/R in the Protocol mittyri 2014-03-14 14:31
        
        the basis of T/R in the Protocol Helmut 2014-03-14 15:01
        
        the basis of T/R in the Protocol mittyri 2014-03-14 21:08
        
        the basis of T/R in the Protocol Helmut 2014-03-14 23:02

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