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Dear Alaa Can you please clarify if the exam focus is different in summer autumn and spring as mentioned in your article? Is the upcoming autumn exam going to focus on EU and pre-marketing? or was the table just an example? Thanks, Vandana ------------------------------ Vandana Dole Andover ...

Can you provide more details. When you say 2 different specifications for the excipient,  what's the impact on the product? Have you done comparison studies? ------------------------------ Vandana Dole Andover MA United States ------------------------------