【摘 要】
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Most biopharmaceuticals are human proteins that are highly specific for their human target.The majority of these biopharmaceuticals therefore are pharmacologically active in humans, the final intended
【机 构】
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Developmental & Reproductive Toxicology, SNBL USA, Everett, WA 98203
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Most biopharmaceuticals are human proteins that are highly specific for their human target.The majority of these biopharmaceuticals therefore are pharmacologically active in humans, the final intended clinical species, and nonhuman primates (NHPs), a nonclinical model of research commonly used for Developmental and Reproductive Toxicology (DART) testing.For the first time, the last two years or so have seen revisions to the ICH guideline documents [ICH S5(R2) and ICH S2(R1)] to include DART in NHPs.This presentation will discuss the evolution of DART NHPs study designs, including juvenile toxicology, over the last six years, trends, and the impact the guidelines have had on the changes that have occurred.
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