Bioequivalence and Bioavailability Forum

food viscosity requirement for fed state BE study as per US sam 2012-10-10 10:53
- Viscosity?! Helmut 2012-10-10 13:38
  - No problem! ElMaestro 2012-10-10 14:25

Registration with Turkey yogesh1004 2012-10-09 18:47
- Registration with Turkey drgunasakaran1 2012-10-09 20:20
  - Registration with Turkey suds4u 2012-10-10 13:06

Mesalamine pAUC jag009 2012-10-05 22:37
- Mesalamine pAUC Ohlbe 2012-10-05 22:45
  - Mesalamine pAUC jag009 2012-10-05 23:00

when do DCGI require preclinical toxicity data AB 2012-10-04 12:45

Fed study dixit 2012-09-24 10:35
- Fed study ElMaestro 2012-09-24 10:49
- Fed study The Outlaw Torn 2012-09-25 07:39
  - Fed study Dr_Dan 2012-09-25 11:11
- Fed study sam 2012-09-29 06:21
  - Fed study Dr_Dan 2012-10-01 10:52

Deficiency response kamblpa2 2012-08-13 10:33
- Deficiency response Ohlbe 2012-08-14 00:17
- CMDh reminder Ohlbe 2012-09-25 19:01
  - CMDh reminder ElMaestro 2012-09-25 20:21
    - CMDh reminder Ohlbe 2012-09-25 22:06
      - CMDh reminder Dr_Dan 2012-09-26 11:35
        
        Long-term storage samples? Helmut 2012-09-26 14:48
        CMDh reminder ElMaestro 2012-09-26 17:30
        
        CMDh reminder Ohlbe 2012-09-27 23:15
        
        CMDh reminder Dr_Dan 2012-09-28 15:32
        
        CMDh reminder ElMaestro 2012-09-28 17:04
        
        90%+ off-topic Helmut 2012-09-28 17:48
        
        90%+ off-topic ElMaestro 2012-09-29 09:30

Method validation sample outlier konkous 2012-09-28 13:43

Expedited review from IEC vivekanand 2012-09-26 06:55
- Expedited review from IEC drgunasakaran1 2012-09-26 09:14
- Expedited review from IEC Ohlbe 2012-09-26 10:17
- Similar ≠ same Helmut 2012-09-26 15:03

USFDA requirement for randomization Ravi 2012-06-15 13:39
- randomization: validation Helmut 2012-06-15 17:39
  - randomization: runs test? validation? d_labes 2012-06-16 13:10
    - randomization: runs test? validation? Helmut 2012-06-16 14:00
      - probability nearly zero? d_labes 2012-06-16 16:11
        
        probability nearly zero! Helmut 2012-06-16 17:08
        
        R-package randomizeBE d_labes 2012-07-06 09:54
        
        R-package randomizeBE Helmut 2012-07-06 12:51
  - randomization: validation ElMaestro 2012-06-16 13:31
    - randomization: runs test Helmut 2012-06-16 14:42
      - randomization: runs test ElMaestro 2012-06-16 14:48
        
        randomization: runs test Helmut 2012-06-16 15:10
      - very cool coding style ElMaestro 2012-06-16 19:12
        
        Better a good steal than a bad reinvention Helmut 2012-06-17 13:22
        
        Better a good steal than a bad reinvention ElMaestro 2012-06-17 19:58
        
        Sorry! Helmut 2012-06-18 13:26
        
        Sorry! ElMaestro 2012-06-18 15:19
        
        Dancing with the dice d_labes 2012-06-18 15:38
        
        Silly's randomization 2x2 xover d_labes 2012-06-18 16:30
        
        Silly's randomization 2x2 xover Helmut 2012-06-18 17:14
        
        Clumsy code Helmut 2012-06-18 17:42
        
        Clumsy code ElMaestro 2012-06-18 18:01
        
        Speed kills Helmut 2012-06-18 18:56
        
        Speed kills jag009 2012-09-17 21:46

BE study – 3×6 design manu126 2012-09-14 08:33
- BE study – 3×6 design Ben 2012-09-17 17:32

Multiple dose studies waived based on single dose studies rana 2012-09-14 11:32
- Multiple dose studies waived based on single dose studies drgunasakaran1 2012-09-14 13:09
- MD waiving based on SD 90–111% CI unlikely Helmut 2012-09-14 14:05

BE analysis – sensitivity analysis manu126 2012-09-14 08:23
- BE analysis – sensitivity analysis ElMaestro 2012-09-14 09:14

Retention period of Investigational products and documents vivekanand 2012-09-13 07:10

DMF open part of Levothyroxine Jasim Uddin 2012-09-07 15:32

COA for Reference Product Jasim Uddin 2012-09-04 12:11
- COA for Reference Product Dr_Dan 2012-09-04 14:07
  - COA for Reference Product Ohlbe 2012-09-04 16:13
  - COA for Reference Product Jasim Uddin 2012-09-07 15:26

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