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이혜원 ( Hae Won Lee ),윤영란 ( Mi Sun Lim ),임미선 ( Sook Jin Seong ),성숙진 ( Joo Mi Lee ),이주미 ( Sung Min Park ),박성민 ( Keum Han Noh ),노금한 ( Sung Ho Park ),박성호 ( Eun Jung Kim ),김은정 ( Won Ku Kang ),강원구 ( Young Ra 영남대학교 약품개발연구소 2012 영남대학교 약품개발연구소 연구업적집 Vol.22 No.0
Modem biologics are biotechnology-derived therapeutics, ineluding recombinant therapeutie proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologic should be evalu-ated based on the same general principles as small molecules, careful considerations should be given to bioanalyties and phannacokinetics when designing pharmaeokinetic studies of biologics during their drug development, due to their dif-feren physicochemical properties compared with small molecules. The aim of this study was to develop draft guid-ance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug. Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Hannom-isation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this drall guidance, the specitic problems to the pharmacokinetics of therapeutic biologics that need special consideration sideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.