参照美国FDA和欧盟药品监管局监管指南用体外方法评估潜在的药物相互作用.pdf

IN VITRO ASSESSMENT OF POTENTIAL DRUG-DRUG INTERACTIONS FOLLOWING THE FDA AND EMA GUIDANCE Outline Abbreviations •ADME • C max.u • CYP • DDI • EMA • HLM •TDI • UGT Pharmacokinetics (PK) Based DDIs PERPETRATOR VICTIM • Fate of a Drug In Vivo (ADME) • • • • Two Key Players in ADME Interactions with Enzymes/Transporters Victim and Perpetrator Adverse Consequences of DDIs • • 1000 ) M n ( n o i t a 100 r t n e c n o C a 10 m s a l P 1 0 6 12 18 24 Time (hour) Examples of Victim and Perpetrators n t e n i e r n i c e e l o i c y l l