ICH E9 (R1) 臨床試験のための統計的原則〜中間事象に対するストラテジー

ICH E9は、1998年に通知された臨床試験のための統計的原則です。その補遺であるE9(R1)は、臨床試験の目的とそれを解決するためのデザインから解析方法までを筋道立てて考えるフレームワークを提供します。治験に関わる者には認知されつつある考え方ですが、アカデミアでの普及は今ひとつです。しかし、その重要性や有用性はアカデミアでおこなう臨床試験にもあてはめることができます。
このスライドでは、E9(R1)の中の「中間事象に対応するためのストラテジー：A.3.2〜A.4」についてまとめました。

Transcript

1. *$)& 3
   ྟচࢼݧͷͨΊͷ౷ܭతݪଇɹิҨͷ֓ཁɾࣄྫ
   

   ྟচࢼݧʹ͓͚ΔFTUJNBOEͱײ౓෼ੳ
   ྟচӸֶݚڀʹ͓͚Δใࠂͷ࣭޲্ͷͨΊͷ౷ܭֶͷݚڀձ
   ୈճݚڀूձ
   ࠤ౻ढ़ଠ࿕
   ৫ా఩࿕
   தాඒ௡ࢠ
   

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2. *$)&ͱ͸Կ͔ʁ
   2
   ྟচࢼݧͷͨΊͷ౷ܭతݪଇʢಠཱߦ੓๏ਓҩༀ඼ҩྍػث૯߹ػߏʣɺIUUQTXXXQNEBHPKQJOUBDUJWJUJFTJOUIBSNPOZJDIIUNM
   w *$)ͷ߹ҙʹج͖ͮɺྟচࢼݧʹ͓͚Δ౷ܭతݪଇʹ͍ͭͯهࡌͨ͠΋ͷ
   w ঝೝ৹ࠪͷͨΊͷࢿྉͰ͋Δ͕ɺҰൠతͳྟচࢼݧʢ؍࡯ݚڀ΋ؚΉʣʹ΋ద༻Մೳ
   w ྟচࢼݧ͔ΒಘΒΕΔ݁ՌͷภΓΛ࠷খʹ͠ɺਫ਼౓Λ࠷େʹ͢Δ͜ͱΛ໨ඪͱ͢Δ
   

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3. *$)& 3
   ͱ͸Կ͔ʁ
   3
   ಠཱߦ੓๏ਓҩༀ඼ҩྍػث૯߹ػߏɺIUUQTXXXQNEBHPKQJOUBDUJWJUJFTJOUIBSNPOZJDIIUNM
   w *$)&ͷิҨʢิॿతͳࢿྉʣ
   w ྟচࢼݧͷܭըɺσβΠϯɺ෼ੳͦͯ͠ղऍΛ໌ྎʹ͢Δ͜ͱΛ໨తʹ͍ͯ͠Δ
   w *$)ͷ࠷ऴ߹ҙ͸͞Ε͍ͯΔɻ೔ຊͰ͸·ͩن੍΁ͷऔΓೖΕΒΕ͍ͯͳ͍
   w ਖ਼ࣜͳ೔ຊޠ༁͸ଘࡏ͠ͳ͍
   w ωοτʹ͋Δ೔ຊޠ༁͸ݹ͍
   w τϨʔχϯάϚςϦΞϧ͕ຊจΑΓΘ͔Γ΍͍͢
   

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4. ࠓճͷษڧձͷΩʔϫʔυ
   4
   தؒࣄ৅
   &TUJNBOE
   ετϥςδʔ
   ײ౓෼ੳ
   

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5. தؒࣄ৅ʹରԠ͢ΔͨΊͷετϥςδʔ
   *$)& 3
   ྟচࢼݧͷͨΊͷ౷ܭతݪଇɹิҨͷ֓ཁɾࣄྫ
   

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6. ͜ͷηΫγϣϯͰѻ͏಺༰
   6
   

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7. ཧ૝తͳྟচࢼݧʢ3$5ʣ
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8. தؒࣄ৅͕ى͜ΔͱͲ͏ͳΔ͔ʁ
   8
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9. &TUJNBOEͷߏ੒ཁૉʢ&TUJNBOEBUUSJCVUFTʣ
   9
   & 3
   ʹ४ͨ͡
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10. $2͔Β&TUJNBOEετϥςδʔ΁
    10
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    ݚڀ໨త தؒࣄ৅
    ࣏ྍํ਑ ର৅ूஂ ม਺
    ͲͷΑ͏ʹதؒࣄ৅ΛऔΓѻ͏͔ʁ
    
    &TUJNBOEετϥςδ—
    w ࣏ྍํ਑ετϥςδʔʢ5SFBUNFOUQPMJDZTUSBUFHZʣ
    w Ծ૝ετϥςδʔʢ)ZQPUIFUJDBMTUSBUFHZʣ
    w ෳ߹ετϥςδʔʢ$PNQPTJUFTUSBUFHZʣ
    w ࣏ྍԼετϥςδʔʢ8IJMFPOUSFBUNFOUTUSBUFHZʣ
    w ओཁ૚ετϥςδʔʢ1SJODJQBMTUSBUVNTUSBUFHZʣ
    

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11. ࣏ྍํ਑ετϥςδʔʢ5SFBUNFOUQPMJDZTUSBUFHZʣᶃ
    11
    w தؒࣄ৅ͷൃੜͱ͸ແؔ܎ʹɺ࣏ྍޮՌΛఆٛ͢Δ
    ױऀ
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    ױऀ
    தؒࣄ৅ͳ͠ɺࢼݧ׬਱
    தؒࣄ৅ൃੜɺࢼݧ్த୤མ
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    #BTFMJOF NPOUIT
    ϨεΩϡʔ
    ױऀ
    ױऀ
    ױऀ
    தؒࣄ৅ͳ͠ɺࢼݧ׬਱
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    ࢼݧ్த୤མͨ͠ͱ͜Ζ·Ͱͷ৘ใͰɺ
    

    ࠷ऴ؍࡯࣌ͷσʔλΛิ׬
    #BTFMJOF NPOUIT
    ϨεΩϡʔ
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    ͦͷͱ͖ͷूஂ৘ใͷΈͰɺ
    

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12. ࣏ྍํ਑ετϥςδʔᶄ
    12
    ױऀ
    ױऀ
    ױऀ
    தؒࣄ৅ͳ͠ɺࢼݧ׬਱
    தؒࣄ৅ൃੜͯ͠΋ɺ࠷ऴ؍࡯·Ͱ௥੻
    ࢼݧ్த୤མͨ͠ͱ͜Ζ·Ͱͷ৘ใͰɺ
    

    ࠷ऴ؍࡯࣌ͷσʔλΛิ׬
    #BTFMJOF NPOUIT
    ϨεΩϡʔ
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    w ิ׬ํ๏͸೉͍͠
    w ऴ຤Πϕϯτʢࢮ๢ʣͷ৔߹ɺͲ͏͢Δ͔
    w ͦ΋ͦ΋ิ׬͢Δ΋ͷͱ͸ʁ
    *$)& 3
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    w ࣏ྍதࢭͱࢼݧதࢭͱΛ۠ผ͢Δ
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13. Ծ૝ετϥςδʔʢ)ZQPUIFUJDBMTUSBUFHZʣ
    13
    w தؒࣄ৅͕ى͖ͯͳ͍͜ͱΛԾఆͯ͠ɺ࣏ྍޮՌΛఆٛ
    w ྙཧతͳཧ༝͔ΒϨεΩϡʔ͕ඞཁ͕ͩɺϨεΩϡʔΛ࢖Θͳ͔ͬͨ৔߹ͷ࣏ྍޮՌΛ஌Γ͍ͨ
    w ͍ͭ͘΋ͷԾ૝ঢ়ଶΛఆٛͰ͖Δ
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    ࠷ऴ؍࡯࣌ͷσʔλΛิ׬
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14. ෳ߹ετϥςδʔʢ$PNQPTJUFTUSBUFHZʣ
    14
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15. ࣏ྍԼετϥςδʔʢ8IJMFPOUSFBUNFOUTUSBUFHZʣ
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16. ओཁ૚ετϥςδʔʢ1SJODJQBMTUSBUVNTUSBUFHZʣ
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17. ετϥςδʔͷ੔ཧ
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18. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶃ
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21. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶆ
    21
    3VCJOP% "CSBIBNTTPO/ %BWJFT. )FTTF% (SFFOXBZ'- +FOTFO$ FUBM&
    ff
    FDUPG$POUJOVFE8FFLMZ4VCDVUBOFPVT4FNBHMVUJEFWT1MBDFCP
    PO8FJHIU-PTT.BJOUFOBODFJO"EVMUT8JUI0WFSXFJHIUPS0CFTJUZ5IF45&13BOEPNJ[FE$MJOJDBM5SJBM+".""QS
    r
    
    ໨తɺ&TUJNBOEɺղੳํ๏·ͰҰཡ
    

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22. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶇ
    22
    3VCJOP% "CSBIBNTTPO/ %BWJFT. )FTTF% (SFFOXBZ'- +FOTFO$ FUBM&
    ff
    FDUPG$POUJOVFE8FFLMZ4VCDVUBOFPVT4FNBHMVUJEFWT1MBDFCP
    PO8FJHIU-PTT.BJOUFOBODFJO"EVMUT8JUI0WFSXFJHIUPS0CFTJUZ5IF45&13BOEPNJ[FE$MJOJDBM5SJBM+".""QS
    r
    
    શ෦ॻ͚ΔΘ͚͸ͳ͍ɺαϓϦʹ·Θ͢
    

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23. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶈ
    23
    3VCJOP% "CSBIBNTTPO/ %BWJFT. )FTTF% (SFFOXBZ'- +FOTFO$ FUBM&
    ff
    FDUPG$POUJOVFE8FFLMZ4VCDVUBOFPVT4FNBHMVUJEFWT1MBDFCP
    PO8FJHIU-PTT.BJOUFOBODFJO"EVMUT8JUI0WFSXFJHIUPS0CFTJUZ5IF45&13BOEPNJ[FE$MJOJDBM5SJBM+".""QS
    r
    
    ਤʹ΋&TUJNBOEΛ൓ө
    

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24. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶃ
    24
    w ຫੑด࠹ੑഏ࣬ױʢ$01%ʣʹର͢ΔࡎʹΑΔݻఆ༻ྔϨδϝϯ͸༻ྔͰ͸ݕ౼͞Ε͍ͯͳ͍
    w ٵೖεςϩΠυɺ௕࣌ؒ࡞༻ੑ߅ίϦϯༀʢ-"."ʣɺ௕࣌ؒ࡞༻ੑЌܹࢗༀʢ-"#"ʣ
    w ओཁධՁ߲໨ɿ$01%૿ѱͷ೥ؒൃੜ཰
    w ࣏ྍதࢭޙ΋σʔλऔಘ
    ࡎซ༻ʢٵೖεςϩΠυЖHʣ
    ࡎซ༻ʢٵೖεςϩΠυЖHʣ
    ࡎซ༻"
    ࡎซ༻#
    ݚڀܭըॻΑΓҾ༻
    3BCF,' .BSUJOF['+ 'FSHVTPO(5 8BOH$ 4JOHI% 8FE[JDIB+" FUBM5SJQMF*OIBMFE5IFSBQZBU5XP
    (MVDPDPSUJDPJE%PTFTJO.PEFSBUFUP7FSZ4FWFSF$01%/&OHM+.FE+VM
    r
    

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25. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶄ
    25
    3BCF,' .BSUJOF['+ 'FSHVTPO(5 8BOH$ 4JOHI% 8FE[JDIB+" FUBM5SJQMF*OIBMFE5IFSBQZBU5XP(MVDPDPSUJDPJE%PTFTJO.PEFSBUFUP
    7FSZ4FWFSF$01%/&OHM+.FE+VM
    r
    &/%10*/54
    

    "DPNQSFIFOTJWFGSBNFXPSL BTEFTDSJCFEJO
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    USFBUNFOUF
    ff
    FDU JODMVEJOHUIFIBOEMJOHPG
    QPUFOUJBMMZDPOGPVOEJOHFWFOUT TVDIBT
    USFBUNFOUEJTDPOUJOVBUJPOT
    

    &BDIBQQSPBDIJTEFOPUFECZBEJ
    ff
    FSFOU
    lFTUJNBOEzŠBUBSHFUPGFTUJNBUJPOUIBUJODMVEFT
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    WBSJBCMFPSWBSJBCMFTBOEQSFTQFDJ
    fi
    FTUIFXBZJO
    XIJDIUIFTFDPOGPVOEJOHFWFOUTXJMMCFIBOEMFE
    JOUIFBOBMZTJT
    ࣏ྍதࢭͳͲͷજࡏతͳަབྷࣄ৅ͷऔΓѻ͍Λؚ
    Ή࣏ྍޮՌͷਪఆ஋ͷهड़Λ໌֬ʹ͢ΔͨΊʹɺ
    ࠷ۙͷن੍ΨΠυϥΠϯʹهࡌ͞Ε͍ͯΔแׅత
    ͳ࿮૊ΈΛ࢖༻ͨ͠ɻ
    

    ֤Ξϓϩʔν͸ɺҟͳΔʮFTUJNBOEʯʹΑͬͯࣔ
    ͞ΕΔɻ&TUJNBOEͱ͸ɺղੳूஂͱΤϯυϙΠϯ
    τม਺ΛؚΉਪఆର৅Ͱ͋Γɺղੳʹ͓͍ͯ͜Ε
    Βͷަབྷࣄ৅ΛͲͷΑ͏ʹѻ͏͔Λ͋Β͔͡Ίن
    ఆ͢Δɻ
    ֓೦ͷઆ໌͕ඞཁ
    

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26. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶅ
    26
    3BCF,' .BSUJOF['+ 'FSHVTPO(5 8BOH$ 4JOHI% 8FE[JDIB+" FUBM5SJQMF*OIBMFE5IFSBQZBU5XP(MVDPDPSUJDPJE%PTFTJO.PEFSBUFUP
    7FSZ4FWFSF$01%/&OHM+.FE+VM
    r
    &TUJNBOE આ໌ ղੳର৅ूஂ
    & 3
    Ͱͷ
    &TUJNBOE
    1SJNBSZ
    FTUJNBOE
    &
    ffi
    DBDZ
    ࣮ࡍͷ९कঢ়گʹؔ܎ͳ͘ɺݚڀظؒத͸ϥϯμϜԽ͞
    Ε࣏ͨྍ͕ܧଓ͢ΔͱԾఆͨ͠৔߹ͷɺ͢΂ͯͷඃݧऀ
    ʹ͓͚ΔϥϯμϜʹׂΓ෇͚ΒΕ࣏ͨྍޮՌ
    NPEJ
    fi
    FE*55
    Ծ૝
    ࣏ྍԼ
    "EEJUJPOBM
    FTUJNBOE
    "UUSJCVUBCMF
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    ͞Εͨ౤ༀͷதࢭΛ޷·͘͠ͳ͍݁ՌͱΈͳ࣏ͨ͠ྍ
    ޮՌ
    NPEJ
    fi
    FE*55
    ෳ߹
    ࣏ྍԼ
    5SFBUNFOU
    QPMJDZ
    ϥϯμϜԽ͞Ε࣏ͨྍ͕ܧଓ͞ΕΔ͔Ͳ͏͔ʹؔ܎ͳ
    ͍ɺϥϯμϜʹׂΓ෇͚ΒΕ࣏ͨྍޮՌ
    *55 ࣏ྍํ਑
    1FSQSPUPDPM
    ݚڀܭըॻ͔Βͷେ͖ͳҳ୤͕ͳ͍ूஂʹ͓͚Δ࣏ྍ
    ޮՌ
    114
    NPEJ
    fi
    FE*55ඃݧऀ͕ϥϯμϜׂΓ෇͚͞Ε࣏ͨྍΛதࢭ͢ΔલʹಘΒΕͨσʔλͷΈΛར༻͢Δ*55
    & 3
    ʹͩ͜ΘΒͣɺݚڀͰ஌Γ͍ͨ͜ͱΛ&TUJNBOEʹ͢Δ
    

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27. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶆ
    27
    3BCF,' .BSUJOF['+ 'FSHVTPO(5 8BOH$ 4JOHI% 8FE[JDIB+" FUBM5SJQMF*OIBMFE5IFSBQZBU5XP(MVDPDPSUJDPJE%PTFTJO.PEFSBUFUP
    7FSZ4FWFSF$01%/&OHM+.FE+VM
    r
    શ෦ॻ͚ΔΘ͚͸ͳ͍
    αϓϦʹ·Θ͢
    

    View Slide

28. &TUJNBOEΛߟ͑ΔςϯϓϨʔτ
    28
    ,BOH. ,FOEBMM." 3JCBVEP) 5JFSOFZ$ ;IFOH- 4NFBUPO- FUBM*ODPSQPSBUJOHFTUJNBOETJOUPDMJOJDBMUSJBMTUBUJTUJDBMBOBMZTJTQMBOT$MJO
    5SJBMT+VO
    rͷ5BCMFΛվม
    ໨త ݚڀܭըॻʹهࡌ͞Εͨݚڀ໨తʢؔ৺ͷ͋Δྟচ՝୊ʣ
    ࣏ྍ ؔ৺ͷ͋Δհೖ·ͨ͸࣏ྍ
    &45*."/% ղੳ
    ର৅ूஂ ղੳର৅ूஂ
    ؔ৺ͷ͋Δྟচ্ͷٙ໰ͷର৅ूஂ ूஂϨϕϧͷཁ໿ͷର৅ͱͳΔྟচࢼݧࢀՃऀC
    ม਺ ධՁ߲໨
    ؔ৺ͷ͋Δྟচ্ͷٙ໰ʹରॲ͢ΔͨΊʹɺݸਓϨϕϧͰଌఆ͞ΕΔ߲໨ ม਺͕ղੳ࣌ͲͷΑ͏ʹѻΘΕΔ͔
    தؒࣄ৅ͷऔΓѻ͍ ܽଌ஋ͷऔΓѻ͍
    wதؒࣄ৅ ετϥςδʔB
    
    wதؒࣄ৅ ετϥςδʔB
    
    ֤ʑͷதؒࣄ৅ʹ͍ͭͯهࡌ͢Δɺཧ༝΋͋Δͱྑ͍
    
    ܽଌ஋ͷ୅ೖ๏ͱͦͷલఏͱͳΔԾఆ
    ײ౓෼ੳܽଌ஋ͷҟͳΔରॲ๏
    ूஂϨϕϧͷཁ໿ࢦඪ ղੳख๏
    ࣏ྍͨ͠৔߹ɺ͠ͳ͔ͬͨ৔߹ɺ͋Δ͍͸ೋ܈ؒͷࠩͷධՁͷج൫ͱͳΔ
    

    ධՁ߲໨ͷཁ໿ࢦඪ
    ౷ܭྔʢਪఆྔʣ͕ײ౓෼ੳͰͲͷΑ͏ʹਪఆ͞ΕΔ͔ɿ
    

    ਪఆྔ͝ͱʹ͓͔ΕΔҟͳΔԾఆख๏
    B& 3
    Ͱنఆ͞ΕΔετϥςδʔʹ͸࣏ྍํ਑ɺԾ૝ɺෳ߹ɺԾ૝ɺओཁ૚ετϥςδʔ͕͋Δɻ
    Cղੳର৅ͷ܈͕ෳ਺ଘࡏ͢Δ৔߹͸ ྫଟ܈ࢼݧʹ͓͚Δൺֱରরूஂ
    ɺ͜͜Ͱఆٛͯ͠΋ྑ͍ɻ
    

    View Slide

29. 45&1ͷ&TUJNBOEΛߟ͑Δ
    29
    ໨త ౶೘ප͕ͳ͍աମॏ·ͨ͸ංຬͷ੒ਓʹ͓͍ͯɺηϚάϧνυൽԼ஫NHͷܧଓ౤༩͸ମॏݮগͷҡ࣋ʹͲͷΑ͏ͳޮՌΛ༩͑Δ͔ʁ
    ࣏ྍ ηϚάϧνυൽԼ஫NHͷܧଓ౤༩ɺϓϥηϘ౤༩
    &45*."/% ղੳ
    ର৅ूஂ ղੳର৅ूஂ
    ౶೘ප͕ͳ͍աମॏ·ͨ͸ංຬͷ੒ਓ
    ࣏ྍΛ։͔࢝ͨ͠Ͳ͏͔ʹ͔͔ΘΒͣɺ࣏ྍΛແ࡞ҝʹׂΓ෇͚ΒΕͨ͢΂ͯ
    ͷࢀՃऀ
    ม਺ ධՁ߲໨
    ମॏʢXFFL ʣ XFFL͔ΒͷମॏͷมԽྔʢओཁධՁ߲໨͸XFFLͷมԽྔʣ
    தؒࣄ৅ͷऔΓѻ͍ ܽଌ஋ͷऔΓѻ͍
    ᶃ࣏ྍ୤མɾதࢭɾϨεΩϡʔ ࣏ྍํ਑ετϥςδʔ
    
    

    ˠதؒࣄ৅ʹؔΘΒͳ͍࣏ྍͷޮՌʹؔ৺͕͋Δཧ༝
    

    ᶄ࣏ྍ୤མɾதࢭɾϨεΩϡʔ Ծ૝ετϥςδʔ
    
    

    ˠதؒࣄ৅͕ͳ͘ɺ࣏ྍΛܧଓͨ͠ͱԾఆͨ͠ޮՌʹؔ৺͕͋Δཧ༝
    ᶃಉ͡܈಺ͷଟॏ୅ೖ๏ͰXFFLͷ஋Λิ׬ɻ
    

    ᶄXFFL͔Βͷ৘ใΛར༻ɻதؒࣄ৅͕ൃੜͨ͠৔߹ɺͦͷલͷ࣌఺·Ͱ
    ͷ৘ใΛར༻ɻ
    ूஂϨϕϧͷཁ໿ࢦඪ ղੳख๏
    ฏۉ஋
    ᶃ"/$07"ɿ܈ͱXFFLͷཁҼɻ
    

    ᶄ܁Γฦ͠ଌఆͷͨΊͷࠞ߹ޮՌϞσϧɿ܈ɺXFFLɺXFFLͷཁҼɻࢀՃ
    ऀ͝ͱʹωετɻແߏ଄ͷڞ෼ࢄߦྻΛར༻ɻ
    

    View Slide

30. &TUJNBOEΛҙࣝͨ͠ݚڀܭը
    30
    3BUJUDI# #FMM+ .BMMJODLSPEU$ #BSUMFUU+8 (PFM/ .PMFOCFSHIT( FUBM$IPPTJOH&TUJNBOETJO$MJOJDBM5SJBMT1VUUJOHUIF*$)& 3
    *OUP
    1SBDUJDF5IFS*OOPW3FHVM4DJ.BS
    rͷ'JHVSFΛվม
    ݚڀ໨తͷఆٛ Bҙࢥܾఆऀͷಉఆ
    w ݚڀ݁ՌΛ୭͕ར༻͢Δͷ͔ʁ
    w ୭͕ݚڀͷ੒൱ΛܾΊΔ͔ʁ
    ɹ&TUJNBOE͕มΘΔ
    Cݚڀ໨తͷఆٛ
    w ҙࢥܾఆऀͷ஌Γ͍ͨ͜ͱΛ޿͘ݕ౼͢Δ
    w ݕ౼ʹ͸ɺϥϯμϜׂΓ෇͚͢Δ࣏ྍɺױऀ
    ूஂɺΤϯυϙΠϯτɺ͞·͟·ͳ࣌ؒʢ؍
    ࡯ظؒɺ࣏ྍظؒɺ४උظؒ౳ʣ΋ؚΊΔ
    &TUJNBOEͷఆٛ BՄೳੑͷ͋Δதؒࣄ৅Λಉఆ
    w ؍࡯ظؒ಺ʹൃੜ͢ΔՄೳੑͷ͋Δ
    தؒࣄ৅Λ͢΂ͯϦετΞοϓ͠ɺൃ
    ੜՄೳੑ΋ࣔ͢
    w όΠΞεʹ͍ͭͯ΋ݕ౼͢Δ
    C࣏ྍܭըͷఆٛ
    w ݚڀʹ͓͚Δ࣏ྍܭըͷৄࡉΛఆٛ
    ͢Δ
    w தؒࣄ৅΋ؚΊͨޮՌΛ஌Γ͍͔ͨ
    ݕ౼͢Δ
    D&TUJNBOEͷఆٛ
    w Cͷ࣏ྍܭըʹج͖ͮɺதؒࣄ৅ͷ
    छྨ͝ͱʹετϥςδʔΛݕ౼͢Δ
    w தؒࣄ৅ͱετϥςδʔΑΓɺର৅
    ूஂͱม਺ͱཁ໿ࢦඪΛܾΊΔ
    w ݚڀ໨త͕FTUJNBOEͱ߹க͍ͯ͠Δ
    ͔֬ೝ͢Δ
    B&TUJNBOEʹ༗༻ͳσʔλ C୤མΛ๷͙ํ๏
    σʔλͷऔΓѻ͍
    CओͱͳΔਪఆྔ
    BܽଌϝΧχζϜͷԾఆ
    ղੳܭը
    Dײ౓෼ੳͷਪఆྔ
    EαϯϓϧαΠζ
    

    View Slide

31. ݚڀܭըॻ΁ͷ&TUJNBOEͷهࡌᶃ
    31
    w *$).$MJOJDBMFMFDUSPOJD4USVDUVSFE)BSNPOJTFE1SPUPDPM $F4)BS1
    Λࢀߟ
    w ྟচࢼݧͷݚڀܭըॻͷςϯϓϨʔτ
    w ݱࡏ։ൃத
    

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32. ݚڀܭըॻ΁ͷ&TUJNBOEͷهࡌᶄ
    32
    

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33. ݚڀܭըॻɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌ
    33
    3VCJOP% "CSBIBNTTPO/ %BWJFT. )FTTF% (SFFOXBZ'- +FOTFO$ FUBM&
    ff
    FDUPG$POUJOVFE8FFLMZ4VCDVUBOFPVT4FNBHMVUJEFWT1MBDFCP
    PO8FJHIU-PTT.BJOUFOBODFJO"EVMUT8JUI0WFSXFJHIUPS0CFTJUZ5IF45&13BOEPNJ[FE$MJOJDBM5SJBM+".""QS
    r
    
    &TUJNBOEΛ࣠ʹͨ͠ݚڀܭըॻ
    w ͜ͷݚڀͷܭըॻͱ4"1͸ඇৗʹΘ͔Γ΍͍͢
    

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34. ݚڀܭըॻɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌ
    34
    3BCF,' .BSUJOF['+ 'FSHVTPO(5 8BOH$ 4JOHI% 8FE[JDIB+" FUBM5SJQMF*OIBMFE5IFSBQZBU5XP(MVDPDPSUJDPJE%PTFTJO.PEFSBUFUP
    7FSZ4FWFSF$01%/&OHM+.FE+VM
    r
    ౷ܭղੳࣄ߲ͷͱ͜ΖͰ&TUJNBOEΛઆ໌
    

    View Slide

35. &TUJNBOEΛܾΊΔͨΊͷڞಉ࡞ۀ
    35
    ݚڀ໨తɾ&TUJNBOEɾσβΠϯ
    ΈΜͳͰߟ͑Α͏ʂ
    ҩࢣɾҩֶݚڀऀ
    ੜ෺౷ܭՈɾӸֶऀ
    ͦͷଞؔ܎ऀ
    

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36. ֶश͢ΔͨΊͷಓඪ
    36
    w *$)& 3
    "EEFOEVN&TUJNBOEBOETFOTJUJWJUZBOBMZTJTJODMJOJDBMUSJBMT/PW"WBJMBCMFGSPNIUUQTXXXJDIPSHQBHFF
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    DBDZ
    HVJEFMJOFTɹʲΦϦδφϧʳ
    w *$)& 3
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    i
    DBDZHVJEFMJOFT
    

    ʲτϨʔχϯάϚχϡΞϧɻΦϦδφϧΑΓஅવΘ͔Γ΍͍͢ʳ
    w 3BUJUDI# #FMM+ .BMMJODLSPEU$ #BSUMFUU+8 (PFM/ .PMFOCFSHIT( FUBM$IPPTJOH&TUJNBOETJO$MJOJDBM5SJBMT1VUUJOHUIF*$)& 3
    *OUP
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    rʲ࣍ͷ.BMMJODLSPEUͷ࿦จͱηοτɻݚڀ໨త͔Β&TUJNBOE΍ετϥςδʔΛߏங͍ͯ͘͠ྲྀ
    ΕΛৄ͘͠ॻ͍ͯ͋Δʳ
    w .BMMJODLSPEU$) #FMM+ -JV( 3BUJUDI# 0`,FMMZ. -JQLPWJDI* FUBM"MJHOJOH&TUJNBUPST8JUI&TUJNBOETJO$MJOJDBM5SJBMT1VUUJOHUIF*$)
    & 3
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