FDA Official Describes How QbD is Shifting Reviewers' Thinking
This article was originally published in The Gold Sheet
Executive Summary
"I went through several BLAs (biologics license applications) and these were randomly selected. … What is obvious is that in a typical BLA we do have a fairly wide range of parameters that are listed with ranges that are specified and these ranges are supported by data from clinical work, but more importantly from the validation runs that are done to support these parameters."
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