Bioequivalence and Bioavailability Forum • sample size for BA/BE studies

sample size for BA/BE studies [Regulatives / Guidelines]

posted by drmuneesh – 2008-11-28 08:50 (6047 d 03:31 ago) – Posting: # 2827
Views: 7,739
(edited on 2008-11-28 10:07)

Dear EM

As required, the Comparative dissolution profile of the drug is as follows:
Apparatus: USP Type II (Paddle)

Medium: 0.1% SLS in Water



       0 min. 10 min. 15 min. 20 min. 30 min. 45 min. 60 min. 90 min.

Test   0      85      89      89      89      89      88      88 

Ref    0      45      56      62      71      77      81      86



Medium: 0.1% SLS in Acetate buffer PH 4.5



       0 min. 10 min. 15 min. 20 min. 30 min. 45 min. 60 min. 90 min.

Test   0      92      91      98      98      97      96      98 

Ref    0      48      63      68      75      83      86      89



Medium: 0.1% SLS in 0.1N HCL



       0 min. 10 min. 20 min. 30 min. 45 min. 60 min. 90 min.

Test   0      94      95      94      93      92      91 

Ref    0      65      81      86      87      88      90

Regards
Dr Muneesh Garg

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Edit: Formatted using BBCode. [Jaime]

Complete thread:

sample size for BA/BE studies drmuneesh 2008-10-18 09:17 [Regulatives / Guidelines]
- sample size for BA/BE studies shankar 2008-10-18 11:47
  - sample size for BA/BE studies drmuneesh 2008-10-18 12:18
    - sample size for BA/BE studies Ohlbe 2008-10-18 13:32
      - sample size for BA/BE studies drmuneesh 2008-10-19 10:42
      - sample size for BA/BE studies drmuneesh 2008-11-17 14:10
        
        sample size for BA/BE studies ElMaestro 2008-11-17 14:32
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:34
        sample size for BA/BE studiesdrmuneesh 2008-11-28 07:50
        
        sample size for BA/BE studies Helmut 2008-11-17 15:47
        
        sample size for BA/BE studies drmuneesh 2008-11-18 07:44
        
        sample size for BA/BE studies ElMaestro 2008-11-18 08:49
        
        sample size for BA/BE studies drmuneesh 2008-11-18 09:31
        
        sample size for BA/BE studies ElMaestro 2008-11-18 09:59
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:27
        
        sample size for BA/BE studies drmuneesh 2008-11-19 10:14
        
        sample size for BA/BE studies ElMaestro 2008-11-19 10:48
        
        sample size for BA/BE studies drmuneesh 2008-11-20 08:30
        
        CVintra # CVinter # CVtotal Helmut 2008-11-20 11:18
        
        Circulus vitiosus d_labes 2008-11-20 13:57
        
        Sterne! Helmut 2008-11-20 18:11
        
        CVintra # CVinter # CVtotal drmuneesh 2008-11-28 10:37
        
        CVintra # CVinter # CVtotal Helmut 2008-11-29 10:14
        
        CVintra # CVinter # CVtotal drmuneesh 2008-11-30 07:18
        
        is something fishy in case 2? ElMaestro 2008-11-29 15:42
        
        is something fishy in case 2? drmuneesh 2008-11-30 07:17
        
        SAS and sample size d_labes 2008-11-19 11:33
        
        SAS and sample size drmuneesh 2008-11-20 08:31