mayur661
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India,
2010-06-02 16:54
(5869 d 10:28 ago)

Posting: # 5410
Views: 7,945
 

 Macrolide Suspension BE [Study Per­for­mance]

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We are performing Bioequivalence Study of macrolide Suspension with reference product. In every pilot BE study reference product show variation, while test product give uniform data. Due to this reason we are not getting correct bioequivalence? What is reson behind this reference product variation.

Edit: See here. [Helmut]
 
Dr_Dan
★★  

Germany,
2010-06-02 17:30
(5869 d 09:52 ago)

@ mayur661
Posting: # 5416
Views: 6,094
 

 Macrolide Suspension BE

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Please give more information: study design, dose, formulation differences?
—
Kind regards and have a nice day
Dr_Dan
 
mayur661
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India,
2010-06-03 07:38
(5868 d 19:44 ago)

@ Dr_Dan
Posting: # 5420
Views: 6,060
 

 Macrolide Suspension BE

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❝ Please give more information: study design, dose, formulation differences?


Two way cross over design

200 mg/5mL

No iffrence in formulation only API have diffrent hydrate form other than refrence
 
Helmut
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Vienna, Austria,
2010-06-03 14:14
(5868 d 13:08 ago)

@ mayur661
Posting: # 5424
Views: 6,194
 

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