Ahmed meeran
●    

2006-11-21 13:24
(7144 d 08:32 ago)

Posting: # 368
Views: 7,218
 

 Sustained release formulations BE [Design Issues]

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Dear Dr. Helmut

Kindly advise me how to conduct BE for a sustained release formulation in UK/EU. Both the innovator and test products are sustained release formulation of same strength. Whether the studies have to be conducted in s.s.a designs. Whether Both fasting and fed BE has to be conducted. Whether BW can be applied based on the highest dose strength if IVIVC performed. If IVIVC has to be performed on what method. is it by Wagner or Loo - Reigelmann method (but no oral solution data is available) or numerical deconvulation method to be used. Kindly clarify

Sincerly,

D.Ahmed
 
velupharm
☆    

2006-11-30 10:54
(7135 d 11:02 ago)

@ Ahmed meeran
Posting: # 376
Views: 5,399
 

 Sustained release formulations BE

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Dear ahmed
you can refer to page no 8 of this link document,where you can get clarity on types of studies to be done
 
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