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“A few of our observations touched on the same areas as F.D.A.’s inspectional findings,” said Ray Godlewski, vice president for quality at Baxter’s medication delivery business. Mr. Godlewski refused to be more specific because, he said, of a confidentiality agreement with Scientific Protein.

A line of further research may focus on mechanisms of size scaling in specific PD subgroups in order to find an explanation for the existing interstudy variability.