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鍿Y :N縊嶯癲橯魦ffN悢^翄y翂 4N奮諎寶N魦ffN (W鼅T梪He膵鱊-N 貜擽 c4N奮R粂鶴剉苸虄蛓{|鎷翂 甠 uir瀃寶纇錱亯Bl y N 虄蛓R膥孴yr妅虄*hR恎 R鶴蟢蛓苸虄剉鼅T蕌a婳pe孴鼅T蕌a噑sS a觛鍕苸虄N繈茐鰁颯醤硩鼅T梪He膵鱊蕌ah芉剉yr_'` a觛舥婳pe/ 繈茐鰁@b g剉颯醤硩鼅T梪He膵鱊蕌ah芉剉yr_'` a觛舥婳pe 0
4 . 2 塠hQ'`膵鱊
鵞嶯4N奮諎寶-N鶴皊剉鸑UO4N奮
No倠N鯪孴瀃寶纇錱觺済剉_8^GW 楁嬈~皨U_ 鵞vQNxvzo僫r剉sQT'`蹚L埬嬿N v^鵞@b g
No倠N鯪剉%N蛻 z蹚L$R璭0
4 . 2 . 1
No倠N鯪
鄀簨Nxvz(uo/f&T gsQ 酫/f(W4N奮諎寶-N鶴皊剉
No;Sf[婲鯪孴瀃寶纇錱ch g4N奮aIN剉_8^GW:N
No倠N鯪 A E 0鵞嶯@b g
No倠N鯪GW 椣c饛vQ裇 u鰁魰0c韣鰁魰0Yt猚絜孴l廟_ $R璭vQ%N蛻 z v^ 椖嬿NvQNxvzo僫r剉sQT'`0
4 . 2 . 1 . 1
No倠N鯪剉%N蛻 z
No倠N鯪剉%N蛻 zR:N{0-N0蛻 颯耂gq錘 Nh芉膵鱊
{彟^{彯_陙蓧莡秗 颯譙
Nq_蚑錯8^ u;m;m≧ 莡秗HT N菑'` (W鐍韣(uo g魰陙L銐 鄀 椈l梪0
-N莡秗儚f>f q_蚑譙諎錯8^ u;m;m≧ 莡秗c韣鰁魰儚 颯陙L銐b鵞莡籰梪T銐0 g颯齹r^pbxvz(uo儎vO(u 俌 椣Q\o僫rBR蠎b\Po僆{0
蛻譙諎:gSO烺齹譙_c 1Y籗ck8^錧\O0 u;m齹汻 莡秗c韣鰁魰 梊Po僾^蟸怱_YtT筫齹銐0
4 . 2 . 1 . 2 %N蛻
No倠N鯪
黐魜{k0qS蔛 u}T0 桹Obb鯺昈Ob桍e魰0黐魜c韣剉b%N蛻剉媖緐b:g齹
NhQ0黐魜HQ)Y'`xub_b鶴 u:w0Lv莡剉
No倠N鯪^\%N蛻
No倠N鯪S A E 0
N鎒裇 uS A E xvz擽藌sS菓諷籰梪猚絜 錘軴湒譙諎塠hQ v^(WS A E 裇 u2 4 \鰁匭JT&Ot訷XTO蔛T gsQ;N钀钑0
4 . 2 . 1 . 3 蛻亯
No倠N鯪
/fcd朣 A E 錘Y裇 u剉鸑UO黐魜菓(u垟鵞'`;S梪猚絜俌\Po0螿\BR蠎孴/ b鵞莡籰梪 剉4N奮
No倠N鯪b瀃寶纇錱剉f>f_8^0
4 . 2 . 2
No倠N鯪Nxvzo僫r剉sQT'`膵鱊
9hnc
No倠N鯪剉裇 uNxvzo僫rO(u/f&T gTt剉鰁魰z槒^ o僫r蚐擽{|媁錘蔛\PoT蚐擽/f&T螿{0坢1Yb蛻皊 \
No倠N鯪Nxvzo僫r剉sQT'`膵鱊:N瘈歔 gsQ0坃颯齹 gsQ0颯齹 gsQ0颯齹鄀sQ孴瘈歔鄀sQ0MR N茐\O:NNxvzo僫r颯齹 gsQ 膵鱊:No僫r剉
No偼S擽A D R 0
No倠N鯪Nxvzo僫rsQT'`wQSO俌 N`$瘈歔 gsQwQ gO(uxvzo僫r剉翄nc
No倠N鯪 剉裇 uNxvzo僫rO(u gTt剉鰁魰z槒^
No倠N鯪錘xvzo僫r銐蕬詋vQ諲烻郪銐蕬鬴:NTt0\Po兺S擽3'` 蛻
Y(uo俌済颯L 蚐擽3'`0a$坃颯齹 gsQwQ gO(uxvzo僫r剉翄nc
No倠N鯪剉裇 uNxvzo僫r剉O(u gTt剉鰁魰z槒^0
No倠N鯪錘xvzo僫r銐蕬詋vQ諲烻郪銐蕬鬴:NTt0\Po兺S擽3'`0b$颯齹 gsQwQ gO(uxvzo僫r剉翄nc
No倠N鯪剉裇 uNO(uxvzo僫r(W鰁魰
N剉鴙sQ'`Tt0
No倠N鯪_N颯(uvQ諲烻郪銐蕬0\Po兺S擽3'`0c$颯齹鄀sQwQ gO(uxvzo僫r剉翄nc 裇 u剉
No倠N鯪(uvQ諲烻郪銐蕬鬴Tt0\Po兺S擽4'`b
Nfnx0d$瘈歔鄀sQ*gO(uxvzo僫r bO(uxvzo僫r孴
No倠N鯪裇 u剉鰁魰鄀鴙sQ'` b鍿 gfnx黐魜
No倠N鯪剉烻郪0
擭 o僫r鴙扤\O(u
梑虄o僫r剉o僫r鴙扤\O(uS靊o冦N≧汻f[鴙扤\O(u0o僅ef[鴙扤\O(u孴SOY鴙扤\O(u 亯9hnco僫r剉yr'`eg _U\鴙擽剉xvz 茓vQ諲o僫r鵞vQ梑虄10梑虄;m'`04N奮蚐擽剉q_蚑錘蔛M
O亂蘝0vQwQSO剉諎寶筫誰擽9hnc
N To僫r剉yr筽 愰b0
mQ 4N奮諎寶N魦ffN
4N奮諎寶N罷魦ffN芠R鴙sQ /f魦ffN剉癲橯鶺@x0魦ffN剉0f婮T000悢^翄000(u誰(u蠎000
No偼S擽000亂蘝000鑜a婲y000yr妅篘(uo000o僫r鴙扤\O(u000o僫r菑蠎0004N奮諎寶0錘蔛0o冦N≧汻f[0I{钀R匭筟GW 椢N孾b剉4N奮諎寶-N穬諷0
N, 闟 g4N奮penc硩錘/ec颯聣剉)R蕍/ 螛i栐k噑0颯錘蚐 f鶴 a觛剉蛓{|孴%N蛻 z剉臽礠 N N*NwQSO剉悢^翄Mb齹珗nx0珗硚eQ悢^翄-N剉苸虄 擽 T鰁醤硩$N*Nag鯪0vQ N/f購蛓苸虄擽:N術顅h悢^翄剉魜舥虄 4N奮籰a剉舥婳pe擽髞\`S鍕顅h悢^翄聣遊婳pe剉1 0 髞\1 0 婳 vQ孨/f鍕4N奮籰a剉舥婳剉苸虄f[梪He擽:NndbGP歔nd0婳俌 俌悢^翄遙S靊簚巔t虄>y:S穬梍'`簚巔 R4N奮諎寶-N擽髞\S靊1 0 婳b錘
N饀鵚{Q鶴簚巔t虄剉>y:S穬梍'`簚巔 vQ4N奮梪He擽:N4N奮籰a 苸虄f[梪He擽:NndbGP歔nd0
術汵臽礠 N _N颯\\嶯MR N祂-N剉歔IN剉 1 0 \嶯1 0 婳 舥婳剉魜舥虄硚eQ罷魦ffN剉悢^翄08^購汵臽礠S靊( 1 ) 鍕魜舥虄(WlQ剉 a觛钀MO6q pe蠎\嶯1 0 (W4N奮諎寶xvz-N購蛓 a觛剉pe蠎&{T N,偤N-N1u嶯購汵舥烻SO黐魜 a觛剉~vR詋( 2 ) (W4N奮諎寶-N膵鱊剉魜舥虄-NSOY;m'`NvQ諲鬴Oe a魜舥虄髞\鴙f9e豐 FO@g虄;m'`No僫rSm厤菑苸虄M I C 鰁魰剉曧w gsQ0S_o僫rSmNO嶯M I C M I C sSo僫rSm厤菑M I C 鰁魰`S賬o凈 g剉~vR詋0匭p扂{|梑 u }剉% T > M I C 髞\ 椌0R4 0 % 錘
N S_vQ緩4 0 % ^5 0 % 鰁 剺 g颯穬梍8 5 % 錘
N剉4N奮梪He S_緩0R6 0 % ^7 0 % 鰁 剺 g颯穬梍 gsO苸虄f[梪He0
9 Sm漁V'`梑虄o,g{|梑虄o僫r剉o僫rSm妽貧@g虄\O(u妽:_ 8^GWwQ g儚晞v梑 u }THe擽0SOY梑虄諎寶0≧ir a觛!j媁N篘SO諎寶GW>f:yvQP K / P D 耂pe:NC m a x / M I C NA U C 0 - 2 4 / M I C 0^\dk{|o僫r;N亯 g(l鶺謡鱾{|0 l筓鷭n憑|I{梑虄o0S_ l筓鷭n憑|梑虄o(u嶯簚巔t虄 N|T8TS a觛籰梪A U C 2 4 / M I C 3 5 鰁 颯穬o倉Y梪He0S_C m a x / M I C f螿\ l筓鷭n憑|梑虄o兓l梪S靊軘~GPUS迉虄(W匭剉i梡Q4'`Fg虄 a觛鰁鶴皊o兲儎vqSi'`0
1 0 AmL埮uf[榖筽萐饄螒 u媁榖筽w i l d - t y p e b r e a k p o i n t s 8^錘螒 u媁苸虄M I C R^剉M I C 9 0 \O:N榖筽0
擭0耂噀.s
1 . F D A : G u i d a n c e F o r I n d u s t r y : D e v e l o p i n g A n t i m i c r o b i a l D r u g s G e n e r a l C o n s i d e r a t i o n s F o r C l i n i c a l . 1 9 9 8 t^7 g.
2 . F D A G u i d a n c e F o r I n d u s t r y : E v a l u a t i n g C l i n i c a l S t u d i e s O f A n t i m i c r o b i a l s I n t h e D i v i s i o n O f A n t i - i n f e c t i v e D r u g s P r o d u c t s . 1 9 9 7 t^2 g.
3 . T o m a s R . B e a m J r , D a v i d N . G i l b e r t , a n d C a l v i n M . K u n i n . G e n e r a l G u i d e l i n s F o r t h e C l i n i c a l E v a l u a t i o n o f A n t i - I n f e c t i v e D r u g P r o d u c t s . C l i n i c a l I n f e c t i o u s D i s e a s e 1 9 9 2 1 5 S u p p l : S 5 - 3 2 .
4 . M H L W . 梑虄瑓鑱奮U姟On0000000. H Y P E R L I N K " h t t p : / / w w w . m h l w . g o . j p " h t t p : / / w w w . m h l w . g o . j p , 1 9 9 8 - 0 8 - 2 5 .
5 . I C H E 8 : G e n e r a l C o n s i d e r a t i o n s F o r C l i n i c a l T r i a l s 1 9 9 7 .
6 . I C H E 9 : S t a t i s t i c a l P r i n c i p l e s F o r c l i n i c a l T r i a l s 1 9 9 8 .
7 . 媠w. 4N奮梑 a觛o僫r籰梪f[. 篘lkS u鶴Hr>y. 2 0 0 6 t^1 g,{ NHr.
8 . S F D A : Sf[o僫r4N奮o冦N≧汻f[xvzb/gc黐烻R. 2 0 0 5 t^7 g.
9 . E M E A : N o t e F o r G u i d a n c e O n E v a l u a t i o n O f M e d i c i n a l P r o d u c t s I n d i c a t e d F o r T r e a t m e n t O f B a c t e r i a l I n f e c t i o n s . 2 0 0 4 t^4 g.
1 0 . jl
Y _tZCQ. 瀃(u梑 a觛籰梪f[. 篘lkS u鶴Hr>y. 2 0 1 2 t^9 g,{孨Hr.
1 1 . _魜s^. 甠 uiro僨[. Sf[錧N鶴Hr>y. 2 0 0 3 t^3 g,{ NHr.
1 2 Ng禰餷. 4N奮otf[. 篘lkS u鶴Hr>y. 1 9 9 8 t^2 g,{孨Hr.
1 3 C a r o l i n e S m i t h , C a r o l B u r l e y , M i c k I r e s o n , T o n y J o h n s o n , D e b b i e J o r d a n , S i d o n i e K n i g h t f , . T r e v o r M a s o n , D a n M a s s e y , J u l i e M o s s a n d K e i t h W i l l i a m s . . C l i n i c a l t r i a l s o f a n t i b a c t e r i a l a g e n t s : a p r a c t i c a l g u i d e t o d e s i g n a n d a n a l y s i s . J o u r n a l o f A n t i m i c r o b i a l C h e m o t h e r a p y ( 1 9 9 8 ) 4 1 , 4 6 7 4 8 0 .
mQ0W
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_ T o c 1 5 6 3 6 0 3 0 0
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_ T o c 1 3 8 2 3 4 3 7 8
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_ T o c 1 3 9 2 5 3 6 9 0
_ T o c 1 3 9 1 2 2 2 9 7
_ T o c 1 5 6 3 6 0 3 0 1
_ T o c 1 9 5 9 3 1 0 7 7
_ T o c 1 9 5 9 3 1 3 4 3
_ T o c 1 3 8 2 3 4 3 8 7
_ T o c 1 3 9 1 2 2 2 9 8
_ T o c 1 3 9 1 8 6 3 8 0
_ T o c 1 3 9 2 5 3 6 9 9
_ T o c 1 3 9 1 2 2 2 9 9
_ T o c 1 5 6 3 6 0 3 0 2
_ T o c 1 5 6 3 6 0 6 1 5
_ T o c 1 3 8 2 3 4 3 8 9
_ T o c 1 3 9 1 2 2 3 0 0
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_ T o c 1 3 9 2 5 3 7 0 1
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_ T o c 1 5 6 3 6 0 3 0 3
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_ T o c 1 3 9 1 2 2 3 0 2
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_ T o c 1 3 9 2 5 3 7 0 3
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_ T o c 1 5 6 3 6 0 6 1 8
_ T o c 1 3 8 2 3 4 3 9 4
_ T o c 1 3 9 1 2 2 3 0 5
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_ T o c 1 3 9 2 5 3 7 0 6
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_ T o c 1 3 9 1 2 2 3 0 6
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_ T o c 1 5 6 3 6 0 6 2 0
_ T o c 1 3 8 2 3 4 3 9 6
_ T o c 1 3 9 1 2 2 3 0 7
_ T o c 1 3 9 1 8 6 3 8 9
_ T o c 1 3 9 2 5 3 7 0 8
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_ T o c 1 3 8 2 3 4 3 9 8
_ T o c 1 3 9 1 2 2 3 0 9
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_ T o c 1 3 9 2 5 3 7 1 0
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_ T o c 1 3 8 2 3 4 4 0 0
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F# Microsoft Office Word 97-2003 文档
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