Bioequivalence and Beyond: How toExpand Routine Bioeguivalence StudiestoGenerate NewKnowledgeOphelia Q. P. Yin, Ph. DMoses S. S. Chow, Pharm. DSchool of PharmacyThe Chinese University of Hong Kong
Bioequivalence and Beyond: How to Expand Routine Bioequivalence Studies to Generate New Knowledge Ophelia Q. P. Yin, Ph. D Moses S. S. Chow, Pharm. D School of Pharmacy The Chinese University of Hong Kong
Objective目的To share our experience in bioequivalence (BE)studies交流生物等效性研究的經To discuss how to “transform"’ routine “BE" datato generate new hypotheses and knowledge讨如何将常规生物等效性敷据型，產生新的科研設想和知To initiate an idea of collaboration among ChineseBE centers建護并散動中國生物等效性研究中心之周的广泛合作
Objective 目的 ◼ To share our experience in bioequivalence (BE) studies 交流生物等效性研究的經驗 ◼ To discuss how to “transform” routine “BE” data to generate new hypotheses and knowledge 討論如何將常規生物等效性數据轉型, 產生新的科研設想和知識 ◼ To initiate an idea of collaboration among Chinese BE centers 建議并啟動中國生物等效性研究中心之間的廣泛合作
Bioequivalence (BE) and Generic Drugs仿制藥与生物等效性-28福268101204Time (h)
Bioequivalence (BE) and Generic Drugs 仿制藥与生物等效性 0 1 2 3 0 2 4 6 8 10 12 Time (h) Cp A B
Four aspects of generating newhypotheses and knowledgeDeveloping new pharmacokinetic models/methods建立新的藥物動力學模型和研究方法Linking pharmacokinetics to pharmacodynamics连接藥物動力厚与藥效動力學Linking pharmacokinetics to pharmacogenetics接藥物動力學与遗傅藥理學Determining intra-individual variability测定个体内异
Four aspects of generating new hypotheses and knowledge ◼ Developing new pharmacokinetic models/methods 建立新的藥物動力學模型和研究方法 ◼ Linking pharmacokinetics to pharmacodynamics 連接藥物動力學与藥效動力學 ◼ Linking pharmacokinetics to pharmacogenetics 連接藥物動力學与遺傳藥理學 ◼ Determining intra-individual variability 測定個体內變异
Developing new pharmacokinetic models建立新的藥物動力學模型Plasma concentration200curves manifested distinct180double-peaks160Famotidine-54%140Ranitidine- 50%120100Acetaminophen- 25%806040200031269
Developing new pharmacokinetic models 建立新的藥物動力學模型 0 20 40 60 80 100 120 140 160 180 200 0 3 6 9 12 ◼ Plasma concentration curves manifested distinct double-peaks Famotidine-54% Ranitidine- 50% Acetaminophen- 25%