U.S. Food and Drug Administration, Office of Clinical Pharmacology, DV II, Silver Spring, MD, USA.
Adv Exp Med Biol. 2019;1148:115-129. doi: 10.1007/978-981-13-7709-9_6.
Therapeutic proteins are a rapidly growing class of drugs in clinical settings. The pharmacokinetics (PK) of therapeutic proteins relies on their absorption, distribution, metabolism, and excretion (ADME) properties. Moreover, the ADME properties of therapeutic proteins are impacted by their physicochemical characteristics. Comprehensive evaluation of these characteristics and their impact on ADME properties are critical to successful drug development. This chapter summarizes all relevant physicochemical characteristics and their effect on ADME properties of therapeutic proteins.
治疗性蛋白是临床应用中快速发展的一类药物。治疗性蛋白的药代动力学（PK）依赖于其吸收、分布、代谢和排泄（ADME）特性。此外，治疗性蛋白的 ADME 特性受其物理化学特性的影响。全面评估这些特性及其对 ADME 特性的影响，对成功开发药物至关重要。本章总结了治疗性蛋白的所有相关物理化学特性及其对 ADME 特性的影响。
