药学英语药学英语 (30).pptVIP

Unit Nine Nonclinical Development of Biopharmaceuticals 生物药物 Part two Both biologics and small molecules have to be proven to be pure, safe and potent within their development. Nonclinical development comprises nonclinical drug safety (toxicology and safety pharmacology); nonclinical pharmacokinetics, or PK and bioanalytics for preclinical and clinical sample analysis, including immunogenicity evaluation. 生物制品和小分子药物在其研制过程中，都必须被证明是纯净、安全和有效的。 非临床研究包括非临床药物安全性(毒理和安全性药理);非临床药动学，或PKs；以及为临床前和临床样品分析所做的生物分析，包括免疫原性评估。 All these activities are prerequisites for moving int