Question:

What is "registration batch" and "feasibility batch"?

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I'm reading a document on pharmaceutical study and came across words "registration batch" and "feasibility batch" along with "commercial batch."

I think I understand what "commercial batch" is; however, I'm not quite sure what the other two mean.

If there is someone who is familiar with these terms, please please help me.

Thank you

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  1. I've never gotten a formal definition for these terms but I've come to understand them like this:

    The registration batch is the first round of a drug (in this case) to be considered for entry into the market.

    A feasibility batch refers to how the actual drug will be made. The mechanics of assembling the drug are important in this group.

    I hope this helps and isn't too vague.

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