Bai Jane P F, Burckart Gilbert J, Mulberg Andrew E
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.
J Pharm Sci. 2016 Feb;105(2):476-483. doi: 10.1002/jps.24696. Epub 2016 Jan 12.
Oral bioavailability studies during the development of new medical entities or generic drugs are typically performed in healthy volunteers. Approved drug products are, however, used by patients with diverse disease backgrounds, and by pediatric and elderly patients. To provide the knowledge base for assessing the potential effects of age or co-morbidity on the in vivo performance of an orally absorbed, systemically active drug product, the literature regarding the gastrointestinal (GI) physiological characteristics (pH, permeability, and transit time) in children, in the elderly, and in patients with GI diseases (irritable bowel syndrome, ulcerative colitis, and Crohn's disease) is reviewed herein, with the knowledge gaps highlighted.
在新的医药产品或仿制药的研发过程中，口服生物利用度研究通常在健康志愿者中进行。然而，获批的药品是由具有不同疾病背景的患者，以及儿科和老年患者使用的。为了提供评估年龄或合并症对口服吸收的全身活性药物产品体内性能潜在影响的知识库，本文回顾了有关儿童、老年人以及患有胃肠道疾病（肠易激综合征、溃疡性结肠炎和克罗恩病）患者的胃肠道（GI）生理特征（pH值、通透性和转运时间）的文献，并突出了知识空白。
