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Pharmaceutical Research · 2019 · Vol. 36 · Issue 12 · Springer
Purpose The in vitro and in vivo pharmacologic assessment of ABP 980 similarity to its reference product is intended to compare the activity of ABP 980 and trastuzumab and support the overall conclusion of similarity based on a comprehensive analytical and functional evaluation. Methods This work complements the primary assessment of functional similarity with additional in vitro assays, binding studies, and non-clinical studi...