n=3 - Japan Bioanalysis Forum
Contents
1. htto bioanalysisforum jp 6th JBF Symposium DG2014 12 89 62 BM PK 6th JBF Symposium DG2014 12 htto bioanalysisforum jp 90 63707000000 Q amp A No 25 QC2. platform http bioanalysisforum jp 6th JBF Symposium DG2014 12 43 platform htto bioanalysisforum jp 6th JBF Symposium DG2014 12 44 ZINUUUUUULUUUUNUUULUUU PK Biomarker 6 JB
3. n 5 6th JBF Symposium DG2014 12 54 http bioanalysistorum jp J ARAL AA MRD
4. http bioanalysistorum jp 6th JBF Symposium DG2014 12 79 0 LU 6 1 6 2 6 3 6th JBF Symposium DG2014 12 SS S N EL 9 z Q LZ 80 O LT ET LET ETL EY LI Ef LI db gt Ae Y 6 JBF Symposium DG2014 12 htto bioanalysisforum jp 81 O U LU U UU UUU L Y Q amp A No 3 i
5. 6 JBF Symposium DG2014 12 http bioanalysistorum jp 66 77 77777 7777777777777 ES 2 3 se ee HoQc 5 2oz 2 2
6. htto bioanalysisforum jp 6th JBF Symposium DG2014 12 75 gt gt gt Pk gt http bioanalysistorum jp 6th JBF Symposium DG2014 12 76 i LLU gt
7. http bioanalysistorum jp 6th JBF Symposium DG2014 12 77 7777777777777777 aana gt gt gt gt 6th JBF Symposium DG2014 12 78 htto bioanalysisforum jp Oa 5S9 UUOUOOUOUOOUOOU D gt
8. http bioanalysistorum jp 6th JBF Symposium DG2014 12 65 77 77777 7777777777777 EE 24 5 3 LQG HOG Extra QC HOQC n 4 3 LOCK U Bira Qc HQac naa nss cv 2opz
9. http bioanalysistorum jp 6th JBF Symposium DG2014 12 33 12000000000000 og dt A R 6 JBF Symposium DG2014 12 htto bioanalysisforum jp 34 12000000000000 og iM http bioanalysisforum jp D 6th JBF Symposium DG2014 12 35
10. a 5 2 5 S 6th JBF Symposium DG2014 12 49 n Bioanalysis Forum IMSIVUUUUUUUUUU a F 2 A eae Hkk http bioanalysistorum jp 6th JBF Symposium DG2014 12
11. 6 JBF Symposium DG2014 12 htto bioanalysisforum jp 91 6 3 QC htto bioanalysisforum jp 10 6th JBF Symposium DG2014 12 92
12. http bioanalysistorum jp 6th JBF Symposium DG2014 12 31 LAL EPIL ET EP EP EF EF LT ET ET 7 QC QC QC QC http bioanalysistorum jp 6th JBF Symposium DG2014 12 32 LAL EPIL ET EP EP EF EF LT ET EE
13. 5 gt REEN lk nitida 202 http bioanalysistorum jp 6th JBF Symposium DG2014 12 67 4 2 ISSI PK Biomarker ISS gt PK ISR ISs gt Biomarker ISS gt PK ISS Incurred sample stability Incurred sample reanalysis htto bioanalysisforum jp 6th JBF Symposium DG2014
14. 0711 1 Fit for Purpose Method Development and Validation for Successful Biomarker Measurement AAPS Research paper 2005 6th JBF Symposium DG2014 12 59 7 9 gt 777777777777777777777 LL lore ia PK Biomarker PK gt LQC HQC gt Extra QC gt n 3 Biomarker gt gt Pk LQC HQC gt CRO 5 7
15. 6 JBF Symposium DG2014 12 htto bioanalysisforum jp 84 627707007001 PK htto bioanalysisforum jp 6th JBF Symposium DG2014 12 85 62 PK QC BERUM QC QC QC 5 LLOQ L M H ULOQ 3 L M H http bioanalysistorum jp 6th JBF Symposium DG2014 12 86
16. htto bioanalysisforum jp 6th JBF Symposium DG2014 12 71 UUU http bioanalysistorum jp 6th JBF Symposium DG2014 12 72 ILM TMDL LT gt lgG IFN gt IFN a Brees gt gt
17. gt 6 JBF Symposium DG2014 12 htto bioanalysisforum jp 73 gt gt a b COA http bioanalysisforum jp 6th JBF Symposium DG2014 12 74
18. ART 6th JBF Symposium DG2014 12 55 http bioanalysistorum jp n Bioanalysis Forum Je IUUUUUUUUUUN NAA QC ISS Incurred Sample Stability ISS ISR http bioanalysistorum jp 6th JBF Symposium DG2014 12 56 4 7 U UUU PK Biomarker 4 1 4 2 ISS 4 3 6th JBF Symposium DG2014 12 http bioanalysisforum jp 57 MJ A O D L PK Biorrarkerf db gt Ae
19. Q amp A No 25 6th JBF Symposium DG2014 12 82 http bioanalysistorum jp D Jalil DiUdiidiV SiS TOUIT 6 7 v a Ws http bioanalysisforum jp 6th JBF Symposium DG2014 12 83 6 7
20. Pk gt Biomarker Low quality control within 3 times of LLOQ lower limit of qualification High quality control more than one thirds of ULOQ upper limit of qualification 6th JBF Symposium DG2014 12 60 htto bioanalysisforum jp 2777777777777777777777 LIT LTT TILT LI mn PK Biomarker PK Biomarker gt 4 24 3 lt 5 1 3 6 4 24 gt gt PK Biomarker Deep Freezer 80
21. 20 gt Biomarker 20 25 Biomarker http bioanalysistorum jp 6th JBF Symposium DG2014 12 64 2777777777777777777777 gt gt
22. CMC TK PK L PK 6 JBF Symposium DG2014 12 I htto bioanalysisforum jp LZ Un TK PK PK 6th JBF Symposium DG2014 12 37 htto bioanalysisforum jp 2 LBA platform 6th JBF Symposium DG2014 12 P S N 2 Y VU VU Q Q 8 L 38 dt A R Platform Platform Single vendor
23. Platform http bioanalysisforum jp 6th JBF Symposium DG2014 12 39 platform LBA http bioanalysistorum jp Oa 6th JBF Symposium DG2014 12 40 21000000 Platfom TMB pNPP Luminol dioxetane Ruthenium H It is Alexa Fluor Europium Immuno PCR DNA SPR SPR
24. ligand binding assay LBA LBA TCE 2013 JBF DG LBA 4 5 JBF LBA PK Biomarker PATEE 6 JBF Symposium DG2014 12 http bioanalysistorum jp 23 A DG LBA DG LBA PK Biomarker 6 JBF Symposium DG2014 12 http bioanalysistorum jp 24 7O00 2014 5 DG 2014 6 24 8 2014 7 20
25. LAC HQC Extra QC 20 Pk mmionmgtsr LQC HQC Extra QC LQC HQC Extra QC 20 pus a BraOc 8 4 LAC 20 HQC 20 LILIA Extra QC 20 LIN BMV Ek http bioanalysistorum jp m 6th JBF Symposium DG2014 12 63 U 27777777777777777777 PK Biomarker gt PK 20 gt Biomarker Pk
26. Immuno PCR SPR 6th JBF Symposium DG2014 12 htto bioanalysisforum jp 41 2 2 772727777 Bioanalysis Forum platform PK ELISA ECL a ELISA ECL SB S Biomarker ELISA 6th JBF Symposium DG2014 12 42 2 3 Single Mey207 Single vendor LBA platform KF
27. mim 4 1 gt PK Biomarker gt gt gt gt PK Biomarker gt 4 2 ISS 4 3 htto bioanalysisforum jp a 6th JBF Symposium DG2014 12 58 M7000 0 0 PK Biomarker LBA PK Biomarker fit for purpose PK Biomarker Let s manage Fit for purpose successfully http bioanalysistorum jp
28. and stability Ja 3 2 Analytical method validation Back ground Discussion points Analytical method validation Stability htto bioanalysisforum jp 6th JBF Symposium DG2014 12 14 4 Stability Evaluation 4 1 Considerations for Validation Study Stability Evaluations 4 2 Importance of ISS 4 3 Stability evaluation for Biosimilar 6th JBF Symposium DG2014 12 htto bioanalysisforum jp 15 4 Stability evaluation e Background e Discussion points 4 1 Considerations for Validation Study Stability Evaluations gt Target relevant stability samples PK or biomarkers gt Stability conditions and period gt Stability evaluation method using individual sample gt Stability evaluation method using SS spiked sample gt Different criteria for PK and biomarkers gt Handling against incidental criterion non fulfillment 4 2 Importance of ISS 4 3 Stability Evaluation for Biosimilars htto bioanalysisforum jp Standard substance 6th JBF Symposium DG2014 12 16 5 Specificity 6th JBF Symposium DG2014 12 P S N 2 Y VU VU Q Q 8 L 17 Oa 5 Specificity Background Discussion points Related substances and selection When do you not perform the specificity Setting of spiked concentration When a commercial kit is used Is the specificity necessary htto bioanalysisforum jp
29. DG27014 12 Quarititative analysis by LBA PK Biomarker 6th JBF Symposium DG2014 12 htto bioanalysisforum jp Seiji Mito Mitsubishi Tanabe Pharma Corporation Kousuke lijima Kyowa Hakko Kirin Co Ltd Satomi Sasahara JCL Bioassay Corporation Hiroyuki Shimizu Toray Research Center Inc Masako Soma Daiichi Sankyo Co Ltd Fumiaki Meguro LSI Medience Corporation Itadaki Yamaguchi Sumika Chemical Analysis Service Ltd Yoshinobu Yokota Shin Nippon Biomedical Laboratories Ltd 6 JBF Symposium DG2014 12 htto bioanalysisforum jp SUNTTEIy Biotechnology based drugs typified by antibody drugs are currently being developed for various diseases The ligand binding assay LBA is being used for the concentration measurement of these drugs LBA is also commonly used to measure various biomarkers that serve as indices for drug efficacy and safety evaluations In this regard LBA was taken up as one of the topics in a JBF discussion group DG starting in 2013 Presentations were held in the fourth and fifth JBF symposium As to this particular topic the discussion was held with a focus on the quantitative analysis by LBA PK Biomarker 6 JBF Symposium DG2014 12 htto bioanalysisforum jp SUNTTEIy In particular this DG talked about sample preparations LBA platforms surrogate matrices stability assessments specificity reference standards and critical reagent
30. When a related substance exists in a matrix Judgment of necessity for additional specificity testing after a method validation is completed 6th JBF Symposium DG2014 12 18 6 Reference standard UUNGU 6 1 Stability of purchased reference standard 6 2 Handling of lot changes 6 3 Expiration date of critical reagent 6th JBF Symposium DG2014 12 http bioanalysisforum jp 19 pan DIC orum 6 Reference standard Critical reagent e Background e Discussion points Stability of purchased reference standard Handling of lot changes v Reference standard Y Critical reagent v Assay kit Expiration date of critical reagent htto bioanalysisforum jp 6th JBF Symposium DG2014 12 20 DG2014 12 WAZEE PK Biomarker 6th JBF Symposium DG2014 12 htto bioanalysisforum jp JA JCL nieve IP 6th JBF Symposium DG2014 12 http bioanalysistorum jp 22 a
31. 627707007001 PK BM PK BM PK L htto bioanalysisforum jp 6th JBF Symposium DG2014 12 87 627707007001 QC QC 5 LLOQ L M H ULOQ 3 L M H 6th JBF Symposium DG2014 12 http bioanalysistorum jp 88 627707007001 Pk QC 5 LL L M H UL
32. 12 68 m yali DIOVUdIIdalVolo TUT 4ST OTTO DULA gt gt gt gt PK 1 http bioanalysistorum jp Oa 6th JBF Symposium DG2014 12 69 gt IUU 6th JBF Symposium DG2014 12 http bioanalysisforum jp 70 y2 J U U HH
33. 14 12 1 TC 2014 8 20 DG2014 11 F2F 2015 1 6th JBF Symposium DG2014 12 http bioanalysistorum jp 25 nu PWN Be LBA platform 6 JBF Symposium DG2014 12 htto bioanalysisforum jp 26 LUUUUUU 1 1 1 2 6th JBF Symposium DG2014 12 htto bioanalysisforum jp 27 7 U db Ae htto bioanalysisforum jp 6th JBF Symposium DG2014 12 28 i 7 UU L
34. 50 Ia Je enn ea a a CENETA http bioanalysistorum jp 6th JBF Symposium DG2014 12 51 JBE TE REE III LT 1 ii AR ERM htto bioanalysisforum jp 6th JBF Symposium DG2014 12 52 n Bioanalysis Forum m2 LD UUUTTUUOLL htto bioanalysisforum jp 6th JBF Symposium DG2014 12 53 n Bioanalysis Forum me 2 0000000000 ata ala aa ata aa a E a
35. BA http bioanalysistorum jp 6th JBF Symposium DG2014 12 29 1 Smee 2 TOTE ae eS TIAR li 2 gt E 6th JBF Symposium DG2014 12 aps 7 2 Eg gt Se lei TU TU gt Q 30 LAL EP EP ET EP EP EP EF LT EF 7 7 QC 8
36. C 20 CRU 80 CI 6th JBF Symposium DG2014 12 61 htto bioanalysisforum jp 2777777777777777777777 ii ddd gt 2 gt 1 gt 5 7 7 4 gt KY Initia 20 http bioanalysistorum jp 9 Initial x 100 6th JBF Symposium DG2014 12 62 777777 7777777777 77777 IO
37. F Symposium DG2014 12 htto bioanalysisforum jp 45 3 L L ME LL LI PK assay 1 1 1 2 6th JBF Symposium DG2014 12 http bioanalysisforum jp 46 L LI LI db gt Ae htto bioanalysisforum jp 6th JBF Symposium DG2014 12 47 n Bioanaly Forum Js EE ae ee 4 1 ERAIK tE 6th JBF Symposium DG2014 12 48 http bioanalysistorum jp
38. p and e Back ground e Discussion points When to select a low protein binding tip and tubes Do you use the same tip and tube in actual sample analysis When to select to use sample additives Do you use the same additives in actual sample analysis 6 JBF Symposium DG2014 12 qbiadiVolo I OI UIIi tube and sample additives htto bioanalysisforum jp 2 LBA platform 6th JBF Symposium DG2014 12 P S N 2 Y VU VU Q Q 8 L 10 2 LBA platform e Background e Discussion points Commonly used Platforms Priority criteria of Platform selection Risk management of using a Platform supported by a single vendor What should be done when a validated assay have to be changed its platform Will you continue to use an instrument with expired warranty terms htto bioanalysisforum jp 6th JBF Symposium DG2014 12 11 3 Surrogate matrix Focused on PK assay 1 1 Selection of a surrogate matrix 1 2 Analytical method validation and Stability 6th JBF Symposium DG2014 12 http bioanalysisforum jp 12 3 1 Selection of a surrogate rratrix BD ajali DiUOdiic 9 gt ae Back ground Discussion points What is used as a surrogate matrix How to select the surrogate matrix Risk management of using a surrogate matrix 6 JBF Symposium DG2014 12 htto bioanalysisforum jp 13
39. s This presentation gives an overview of contents discussed in the DG to help establish the standard procedures for the quantitative analysis by LBA PK Biomarker and reliability of the assay 6th JBF Symposium DG2014 12 htto bioanalysisforum jp May 2014 Member recruitment from DG supporters 24 Jun 2014 Kick off meeting with 8 members Jul 2014 Dec 2014 Monthly teleconferences and e mail conversations 20 Aug 2014 F2F meeting collaborated with DG2014 11 Jan 2015 Summarizes and preparation poster presentation 6 JBF Symposium DG2014 12 htto bioanalysisforum jp nm A UU N gt Stability evaluation Specificity Reference standard Critical reagent Discussion Themes Sample preparation LBA platform Surrogate matrix htto bioanalysisforum jp 6th JBF Symposium DG2014 12 6 1 Sample preparation 1 1 Operating and inspecting pipette 1 2 Using low protein binding tip and tube and sample additives 6th JBF Symposium DG2014 12 htto bioanalysisforum jp pan DIC 1 1 Operating and inspecting pipette e Back ground e Discussion points Operation Do you use both pipetting modes forward or reverse mode How to select the pipetting mode and the volume range Inspection When to perform the test Test volume 6 JBF Symposium DG2014 12 htto bioanalysisforum jp LT 7 Using low protein binding ti
Download Pdf Manuals
Related Search