Wohlrab Johannes
Universitätsklinik und Poliklinik für Dermatologie und Venerologie, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Saale), Deutschland.
Institut für angewandte Dermatopharmazie, Martin-Luther-Universität Halle-Wittenberg, Halle (Saale), Deutschland.
Hautarzt. 2019 Dec;70(12):926-933. doi: 10.1007/s00105-019-04502-4.
Biopharmaceuticals are pharmaceutical drug products or preparations of pharmaceutical drugs that are of biological origin or are manufactured from biological material. The spectrum of biological drugs is extensive and includes substances isolated from biological material, recombinant RNA molecules, proteins as well as full antibodies, antibody fragments or antibody-drug conjugates. The special features of the molecular properties and functions of biopharmaceuticals require a highly complex, variable structure. Due to the specificity of intended pharmacodynamic effects on a complex biological regulatory system, particularities regarding undesired effects, pharmacokinetics, and safety have to be considered both regulatory and clinical.
生物制药是指源于生物或由生物材料制成的药物产品或药物制剂。生物药物的范围广泛，包括从生物材料中分离出的物质、重组RNA分子、蛋白质以及完整抗体、抗体片段或抗体药物偶联物。生物制药分子特性和功能的特殊之处需要高度复杂、可变的结构。由于对复杂生物调节系统预期的药效学作用具有特异性，在监管和临床方面都必须考虑不良作用、药代动力学和安全性等方面的特殊性。
