Biosimilars [Design Issues]

posted by Kumarnaidu2 – India, 2021-10-22 09:53 (403 d 23:59 ago) – Posting: # 22653
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Dear All,

For a medicinal product to be administer as intravenous infusion (for approx. 3 hrs) if we consider Ctrough as one of the primary pk parameter for demonstrating PK similarity, does different rate of infusion amongst enrolled subjects has any impact on Ctrough levels?

Thanks in advance,

Kumar

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