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1 Institute of Accelerator Analysis Ltd.
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10 HPLC
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13 Drug Concentration (ng/ml) B D F Drug Concentration (ng/ml) CREAM (MD) T007 (MD) CREAM (TD) Time (h) Time (h)
14 14 C-content (dpm/ml) Subject1 Subject2 Subject Time (min)
15 i.v. (MD) p.o. (TD) i.v. (MD simultaneous administration i.v. (TD) AMS (total radioactivity) LC/MS/MS (unchanged drug) Plasma Plasma Plasma AMS (total radioactivity) LC/MS/MS (unchanged drug) AMS (total radioactivity) BA2b p.o. : L/M/M i.v. : AMS BA3 p.o. : L/M/M i.v. : AMS BA1 p.o. : L/M/M i.v. : L/M/M BA2a p.o. : L/M/M i.v. : AMS i.v. (MD) : i.v. infusion of [ 14 C]-R (1.5µg/71.25nCi/kg, microdose) i.v. (TD) : i.v. infusion of [ 14 C]-R (0.3mg/71.25nCi/kg, therapeutic-dose) p.o. (TD) : oral administration of R (1mg/kg, therapeutic-dose)
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19 AME D Phase 1 Cold Hot 14C RI IRB 14CRI AMS
20 14C Hit Lead Phase 1 Phase 2 a,b Conven. Phase 1 Hot Phase 3 POC POC POC Phase2
21 Profile Major Metabolites AUC AUC 10 Metabolites: Human > Animal AUC 10 Metabolites Metabolites Profile Major Metabolites Metabolites
22 14C Tracer Hot Hot Hit Lead Phase 1 Hot Phase 2 Phase 3 MD Cold Phase1 Tracer Hot Hot Phase 1 Profiles Profiles Bioavailability Conven. Hot
23 Tracer Hot Hot Hit Lead Phase 1 Phase 2 Conven. Phase 1 Hot Phase 3 Hot Hit Lead Phase 1 Hot Phase 2 Phase 3 Tracer Tracer Hot Profile Profile
24 Tracer Hot Hot Regulatory RI RI Regulatory Cold Hot Cold Cold Hot Hot Hot Hot RI RI Cold Hot Cold Hot IRB HPLC HPLC AMS AMS L/M/M L/M/M
25 Cold MD Phase 1 GMP Hot Verification Validation RI GLP Certificate of of Analysis
26 RI RI RI RI RI CRO RI RI RI CRO RI RI Hot RI RI RI RI RI OK RI RI OK RI 10 MBq (270Ci)
27 RI -RI RI -RI RI RI RI RI RI RI RI RI RI CRO RI RI RI CRO RI RI Hot OK OK RI RI 10 MBq (270Ci)
28 RI RI Verification & Criteria GMP RI RI vs & Criteria RI RI
29 RI Tracer Tracer Hot SOP SOP Protocol 14C 14C RI RI RI 14CRI Hot Hot IRB IRB Hot- Hot-IRB Informed Informed Consent Consent Hot
30 Tracer Hot - Phase0MD PK Metabolites Profile Tracer Hot Phase1 MtsProfiles Bioavailability (PO, IV
31 Tracer Hot Phase 0 Tracer Hot Hot Phase 0 PK, PK, Metabolites Profile p.o. p.o. (TD) (TD) i.v. i.v. (MD) (MD) PO POor or IV IV administration Plasma AMS (Total radioactivity) HPLC --AMS (Unchanged drug drugradioactivity)
32 Tracer Hot Phase Tracer Hot Hot Phase 1 One One Protocol Tracer Hot Hot Metabolites Profile 6th 6th Dose Dose 5th 5th Dose Dose 4th 4th Dose Dose 3rd 3rd Dose Dose 3rd 3rd Dose Dose + 2nd 2nd Dose Dose Tracer Tracer Hot Hot Dose Dose 1st 1st Dose Dose (Cold
33 Experience of of 14C --Metabolite Profile Analysis Studies Samples HPLC Injection (Total dpm) Conventional Plasma, Urine 20 dpm Human Feces (18 th JSSX 2003, Sapporo) Animal Plasma 3 dpm Human (Tracer) Urine 1 dpm Conventional Plasma 1 dpm Human Animal (Tracer) Plasma, Urine 20 dpm Human Plasma 0.1 dpm Microdose (21 st JSSX 2006, Tokyo)
34 Tracer Hot Phase Tracer Hot Hot Phase 1 Bioavailability p.o. p.o. (TD) (TD) i.v. i.v. (MD) (MD) Simultaneous administration LC/MS/MS (PO) (PO) (Unchanged drug) Plasma AMS (IV) (IV) (Unchanged drug drugradioactivity)
35 MD Hot Hit Conven. Lead Phase 1 Phase 2 Phase 1 Hot Phase 3 Hot Hit Lead Phase 1 Hot Phase 2 Phase 3 MD Cold Cold Phase1 Tracer Tracer Hot Hot Phase Phase 1 Profiles Profiles Bioavailability Conven. Hot
36 Contact for IAA Contact Person- Teiji Miyaoka, Ph.D Address- Institute of Accelerator Analysis Ltd Noborito-Shinmachi Tama-Ku, Kawasaki Kanagawa, Japan Phone- +81 (0) Fax- +81 (0)
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Vol. 36, Special Issue, S 3 S 18 (2015) PK Phase I Introduction to Pharmacokinetic Analysis Focus on Phase I Study 1 2 Kazuro Ikawa 1 and Jun Tanaka 2 1 2 1 Department of Clinical Pharmacotherapy, Hiroshima
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