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Dear All,
If one what to conduct BE of generic modified released product, do we
need to do both Fast and fed condition. According to to US and EU,
do the requirement of BE are the same for modified eleased generic
product.
And the meal recommend for fed need to be as they recommend or just
equivalent in term of protein, carbohydrate and fat. In Asian
countries, the recomended meal is different from what the people have
everyday.
Regards,
Wichittra
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Copyright 1995-2007 David W. A. Bourne (david@boomer.org)