| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5887608 | Seminars in Arthritis and Rheumatism | 2015 | 7 Pages |
Abstract
Clinical trials aim to resolve uncertainties that may remain following nonclinical development regarding the similarity of the proposed biosimilar with the reference product. Pharmacokinetic and pharmacodynamic studies form the backbone of early clinical development and serve to inform phase 3 clinical development. Factors to be considered in clinical development include study population, design, end points, sample size, duration, and analytical methods.
Keywords
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Authors
Rieke MD, Bruce N. MD,