Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8528240 | Clinical Therapeutics | 2018 | 10 Pages |
Abstract
This is the first study to summarize the justification of dose selection and the labeled dose of biologics approved by the FDA. Dose-response analyses have been often used as the rationale for dose selection of registrational studies, although exposure-response analyses are becoming more prevalent in support of the dosing guidelines in labeling.
Keywords
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Authors
Ken PhD, MPH, Christopher D. MD, PhD, Dora H. MHS, G. Caleb MD, MS,