지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
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Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies.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 Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed,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.
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참고문헌 (27)
참고문헌 신청
/ / Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-clinical and Clinical Issues (EMEA/CHMP/BMWP/42832/2005, adopt
/ / Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins (EMEA/CHMP/EWP/89249/2004, adopted in January 2007)
/ / Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function (EMEA/CPMP/EWP/2339/02, adopted in February 2005)
/ / ICH E6: Guideline for Good Clnical Practice (CPMP/ICH/135/95/Step4, adopted in June 1996)
/ / ICH E8: General Considerations for Clinical Trials (CPMP/ICH/291/95, adopted in September 1997)
/ / Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins (EMEA/CHMP/EWP/89249/2004, adopted in January 2007)
/ / Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function (EMEA/CPMP/EWP/2339/02, adopted in February 2005)
/ / ICH E6: Guideline for Good Clnical Practice (CPMP/ICH/135/95/Step4, adopted in June 1996)
/ / ICH E8: General Considerations for Clinical Trials (CPMP/ICH/291/95, adopted in September 1997)
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