                           ˿µϣ2011403գ

11.04.02ûи
11.04.03, ӽרûӦϮšǳˣһһ
11.04.03, ɳԺϴѧУһҵ걨2011ҿƼɡ
11.04.03, ںϴѧڹصʵ걨ٵ
11.04.03, 󡶷ӾûУ
11.04.03, -2010ϷӵļߺͿѧĻˡ
11.04.03, ypliȳӡϮߵĿ
11.04.03, Ф˸Ц
11.04.03, ͡Фˡ
11.04.03, ڳݳ֮Ϳžս
11.04.03, ѧУѧУӰУĹؼ
11.04.03, ˧ףϴѧеѧԺѧ˵˧ʿٴγɹ
11.04.03, ѧܿ˫̤˷ѧĻ˵̶
11.04.03, ذϺ롶ߵһԣδ죩
11.04.03, Ϸбѧ顱ͯ
11.04.03, й걨ѧƸڱָ

˿(www.xys.org)(xys5.dxiong.com)(www.xinyusi.info)(xys2.dropin.org)

ӽרûӦϮš
ǳˣһһ

2010.4.2.

Ѷ ߺ330գĩĸƪ
ɿҡѧٶʿԼҲӳϮ41գӽ
רʱ˵ǳˣһһơҪñ


ĩָӳϮƪ·ֱǡִҩô
ġѧʲôѧؽ⡷2006귢ġ
ҩôġӵͽͳƣӱӵġʶҩ
¾FDAһݲϣֻıȽʵԭģ
ø߼ߣϸӱӵû
ģԲǳϮġ

ĩָѧʲôȫԼ1600֣Լ900ּԭ
޲ؽڵġǿѧ𡷡Դɣӳƣѧ
ʲô1995ϸ˳ʱдӣõĿѧжϱ׼ֻ
˵ǿѧĹʶ1999롶ߡʱעǸ
Root-BernsteinĹɡӰҲûСԭԡԼ
˸ӡ

ĩɡѧؽ⡷Ҫѧ־
Greene˵Ĳһ¡ӽܣ2001Ͷһָؽз
߲鵽20065µһƪ˵ָرѧ༭
ɾǵһ˵˵ĹڶԼĸ


Ӷ˵дƪǿ£±
ռѧ֪ʶչʾѧĳɹ°ǲúϸע
ġԣĵı׼ȥҪǻģͬ
׼

331ջ˵ĩĸУЪѧ
޲ء³ز˹̹ȷ˷ӡѧʲôһĳϮѾ
¡ҥΪýתżȷָû϶
Ϯ¡

41գ롶ĩִܱչһս
ӵ΢ɡĩ˱걻йء
Լ߳ƣ׼߷ɳߡĩ

ĩִܱ1ɷʱ˵
ͷӵ˽˶Թ޹ءóĸɡˡΪû
ýЩɣЩˡûеõ

(XYS20110403)

˿(www.xys.org)(xys5.dxiong.com)(www.xinyusi.info)(xys2.dropin.org)

ԺϴѧУһҵ걨2011ҿƼ

ߣɳ

żȻվϹĽ걨ҿƼĹʾĿ嵥ѵԣ
һЩرעһ¡

ڹҿƼĿȡõľЧϵܴΪЩڱ
ʱʵ걨ĿľЧ档ϴѧȵλ걨ġϢɹؼ
оӦáĹҿƼĿַ
http://168.160.158.231/xmfb/XMView.aspx?XM_ID=20114161ȡõ
Ч޴󣬵һЩָһЩ⣬˶е
˺ʵ

1. ָǹһƼ޹˾ǰλ걨˿Ĺ˾
ԱҲиù˾ԱԼĹ˾֤Ŀȡ˹ڵľЧ棻
ֵǣǹһƼ޹˾ǿƼ˾ĿӦõλ
ӦõλӦǵ˾ôںǹһƼ޹˾ȡô
ľЧ棿

2. ݹϢ޹˾ҲṩӦЧ֤ҹ˾Ҳǿ
˾ĿӦõλұԱ˾ǰĸˡ

3. йҪӦõλȡõľЧ֤ϵҪ걨
˵ͬѧʦֵܣԾкнɵȡ

4. ʡ˾ȡõЧ2ڣϺ繫˾ȡõЧ
1ڣӦõλȡõЧҲ60004000
ȡԣЩЧֲʵݡ

Կ϶Ŀͨѧ¼Ƶ⣬
ʿע

(XYS20110403)

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ںϴѧڹصʵ걨ٵ

ʦ

ãµĹصʵҵĽƻѾ¯ͺϴѧ
Ĺصʵѱ뽨ƻʵҵ걨мӲ
ǲϵġ

صʵҵ걨Ҫ
http://www.most.gov.cn/tztg/201010/t20101019_82740.htm

ϴѧϵļ㣺

1. 걨ָȷ˵걨---ϴѧȴ걨

2. 걨ָҪвʿ㣬ߵԺУйصѧơ
ûвʿ㣬Ӵûйصѧ-----ڶ㲻걨Ҫ

3. ͺӴϣ걨λÿλ
ʿ͹صѧƣΨӴϡ

(XYS20110403)

˿(www.xys.org)(xys5.dxiong.com)(www.xinyusi.info)(xys2.dropin.org)

ӾûУ

ߣ
http://blog.sciencenet.cn/u/GumpForrest

ǰһʱ䣬дƪĿŵĿղġһַԺ
Ⱦ!ͬһʱڣϷǸֽҲػ£Ǻ
֪ġһ죬һۣдһƪĿݶ
Ƶ£гϮ֮𣿰һһӦһϲĻˣ
Ȼ˳Ӿȥһ£ͦ񣬴һЩ﷽ʽݶҵ
Ϯĺۼһ˼Ͷʱ䣬ʱйˣֻáӢͬ
οԼˡǳˡ

⼸ָطӳϮʲôĩˣòְҲ
մ֣˻ˮǰۡ


....................................................................
....................................... 

"ӱ"¶Ա£

1ѧо״̬µĸܺͱ仯ɣ
ﻯѧоеĻѧ仯ѧо̵ĸ
ӵĹܺ໥áǾܴӷӡϸٵ岻ͬĲ
˽ǵ״̬¶еģһ淢
쳣

ӱ1ѧоµĸֹܼ仯ɣﻯ
ѧо̵Ļѧѧо̵ĸַӺͷ
ˮƽĸ໥áоԱͼӲͬĲ---ˮƽϸ
ˮƽ---ȥЩı䣬ȥ˼ҩｫδϸͷӲϾЩ
쳣ı䡣

λĶǻ͸е仯Ͳˣ˻
ˣ˵вġӽܵѧ
ѧHuman physiology, ͨѧﻯѧı
Ӹ׼ȷЩѧ仯͡ѧģԷѧıҲһ
ӵġܺ໥áı׼ȷЩЩϱеĻʶ
õų𣿡

2ʱоԱܺܿطĻǺ
ġʱоԱҪɸѡǧֻܷЧ
֡

ӱ2ѧʱˣܽϿҪҵҪĻ---ǰ
˵ǸøƼͨҪһؼ鼸ٸǧ


ҲгϮΣҪ˵ӳˡFrom tube to patients 
ȫͬ⡣Ƚһ£˭ԭĵıЩһ۾Ϳˡ
ԲסˣҪ˵룬ֱ룬ЩӲ
Sometimes, scientists are lucky and find the right compound quickly. 
More often, Gruen says, hundreds or even thousands must be tested.

3Щ޷ʵй۲쵽ġǣ˵Ŀǣ
Ҳֱܾ顣ˣһ׶ΣоԱҪ顣

ӱ3ʵϵͳо޷۲ҩõЩˣһ
оԱҪһҩʵϵͳ---ʵ飬ڶϽһ
⼸ֻЧ

ڶҩ￪̺ͳĽܣ˵üࡢ׼ȷ
ģҲѽ֪ʶͱ﷽ʽĸ߼ӹ

4õʵ鶯С󡢴ӡèӵȡ
ʱҪõֵֻĶΪͬĶҩķӦ
ܻ᲻ͬ

ӱ4õʵ鶯СèӵȣȻЩʵ鶯---
Ϊҽѧʵ鶯---ֶرѧ൱ȷͨ
ͬදﲢܵΡΪҩԲͬĶܲͬã
ͨҪϵĲͬĶϽ顣

ͬϣϵͬʵעǧƪһɣҶһûʲô˵
ġ

5ʱǻ֣ᷢһҩĴлҩﱾ
Ч

ӱ5ʱоԱ֣ᷢҩĳִлֽܱڽ
ҩΪЧҩ뾭лµʲܷЧ

˵񡰳Ϯɣǹ֪ʶΪʲô׼ô˵
ǻÿģ

6IٴΪСģͨΪ20-100ˣ־Ը
߻߶ԡҪĿǹ۲ҩǷּԶãʵ
ȫҩоҩաлйʱ¡
ûص⣬粻ɽܵĶãͿɽIIٴ顣Լ70%
ҩܳɹͨһ׶ε顣
ӱ6Iٴ飬Сģ۲ҩİȫԲȷʵĸ
ҩҲо۲ҩաлйЧ۲첻һڵ
㡣ѡ(־Ը)˽飬ͨ20-100ˣ
¡Լ70%ҩɳɹͨIIٴ顣

Phase I trials are the first stage of testing in human subjects. 
Normally, a small (20-100) group of healthy volunteers will be selected. 
This phase includes trials designed to assess the safety 
(pharmacovigilance), tolerability, pharmacokinetics, and 
pharmacodynamics of a drug. These trials are often conducted in an 
inpatient clinic, where the subject can be observed by full-time staff. 
The subject who receives the drug is usually observed until several 
half-lives of the drug have passed. Phase I trials also normally 
include dose-ranging,
͹۵˵ӵıӢĻǸӽ˳ҲȽһ¡ 
Լ70%ҩܳɹͨһ׶ε顱ϢFrom Tube to patients
ϵıﶼС˵γǾ̫ӲϹˡ

7IIٴΪеȹģǲˣͨΪ100-300
ˡҪĿǹ۲ҩǷЧҲԶڵİȫһ۲졣ʱ
µꡣԼֻ33%ҩܳɹͨһ׶ε飬III
顣

ӱ7IIٴ飬еȹģҪ۲ҩЧһ۲찲
ȫԣȷʵĸҩǲˣͨ100-300ˡ
µꡣƽԼ33%ҩͨIIIٴ顣

8IIIٴΪڴģǲˣͨΪ
1000-3000ˡĿȷҩЧͰȫԣȷҩʱһ
ꡣԼ25-30%ҩͨһ׶ε顣

ӱ8IIIٴ飬ڴģȷҩЧͰȫԣȷҩ
ǲˣͨ1000-3000ˡһꡣԼ25-30%ҩͨ


7-8֣ȰĿȽˣԿҩУ
ֻǰͼȺ˳нܺͽ͡

9IIIٴ֮ҩ˾Ϳҩಿ
룬ҩಿ֯רҼʳƷҩƷ(FDA)׼
ҩֻռٴҩ20%

ӱ9IIIٴҩڽݷ֮ܽҩ
˾룬FDA֯רҽFDA׼еҩ
ֻٴҩ20%

ҩзˣô˵ʲô IIIٴ顱 
ҩ˾ҩಿš롰УʳƷҩƷ(FDA), ҩ
һ仰ֻٴҩ20% 
һ£ʲô

10ҩ׼֮ͨȻҪһ۲ҩڴΧ
ʱٴӦʱЧͰȫԣҩбȽϣΪIVٴ
ٴʱͯи˳ų⣬ҩк
Ҫ۲ҩЩȺĳЩضĲȺİȫԡЧͼΧ
Իøȫϡ

ӱ10ͨҩ׼֮ҪһٴоΪIV
ٴҪоҩĳЧ붾ԣҩıȽϵȡҩ׼
֮Ҫһ۲ҩڴΧʱٴӦʱЧͰȫԡ
رҪ۲ҩԶͯ겡ˣŮͻиŮĳЩضĲȺ
İȫԺЧԼΧԻȡΪȫϡ

ӵġЧͰȫԡӵġЧ붾ԡȻһ
ԡԤںԵĹ۲죬ȫԡĹ۲췶Χˣ
ʵںٴ۲ǰȫԣǶԡ
ⷽӻˡٴʱͯи˳ų
⣬ҩкرҪ۲ҩЩȺĳЩضĲȺ
ȫԡλ˽Բ䣬ΪʲôҪ۲ͯŮˣǲ
Ǹ
볭ԭģPhase 4, Studies performed after a drug is 
approved for marketing. The studies are performed to determine the 
incidence of adverse reactions; to determine the long-term effect of a 
drug; to study a patient population not previously studied; and for 
marketing comparisons against other products and other uses. Լ
Ƚһ£˭ø񣿡

11ʱٴУһҩﱻܹЧƶ
ԼǰֹٴֱƲˡ磬һư̲
ҩAZTٴֻ106֮󣬷Ӳ˵Ĵʣ
ʳƷҩƷǰֹ˸ٴ飬׼֮ǰ
4000̲ߡ

ӱ11ʵϣһĳҩӰ첡˵״̬Ϳͣ
ֹ顣˵ֵһư̲ҩzidoculine---AZT---
Ӳ˴֮FDAǰֹ˸ҩٴ飬׼
ҩ֮ǰȨǧ̲ʹҩٴֻ(
Լ)106ͻ׼

еҲӡһĳҩӰ첡˵״
̬Ϳֹͣ顱仰˵ñȽϺͷԡʵ
˵ǾǡЧֺܽĥߴʲôץٴ
ɡ
Ǹ106һ˵ǡģӽ͹̹ܹ
˵Ӱ죬ѹ

Կ϶˵ӿ϶Ҳӵ£߶Ӱ컹С

վǴͲֻڽһЩ֪ʶûԼѧ
ѧ׵ģĵı׼ȫͬһЩѧ̵ȫ
ǺѧΪѧľʽʧȥʽ
ǻʣʲôѧıйоأ漰һЩרҵһЩ֣
ҳῴȥ

"ΪǳϮ"ҧס˵ԺҲдˣΣ
ţ

ҹŴҲ˭ȥԭȶԣȥӢıȶԣ԰Ҳ
ðЩˡ

(XYS20110403)

˿(www.xys.org)(xys5.dxiong.com)(www.xinyusi.info)(xys2.dropin.org)

ϷӵļߺͿѧĻ

ߣ-2010

աӳϮ顱ĩ 䣩 óۣ

1	Ǳ⵳ΪӳϮ顱дƪ
ĽܷӵġˮѡԼѲİûڣתڽɡϷ
ĩѧĻˣɡܡӵġٵĳ塱
豻롰ߡ¼еĳЩ߿ڱѧ?
н֮ڶԷӽ˸񹥻֮ӡ

2	߲ºѧĵı𣬻Ƕõװ


߲ţҲ֪ѧľص㣺ٿѧԢڴԢԡ
ǳܵƼ³ɾ͡ѧҵĿгɹ
ҪڰѸӵĿѧ֪ʶѧͨ׵Լ˵ʹһ
ܹеĵ

߿ԸεĸߣǴûйˮѡ
Ƿв١ʼյһֱάѡдģ
10֮ܽܡĩ߲ɷʱ˵ڲý
ѧȦĲԸ̸ˡֻҼ֣ҽѲ
ҵǸ̲סЦܵƤ̫񣬻߿˵ܸ
ûƤһ߷ӴûܵѽȴΪ
ѲԷΪӽ롰ڿѧȦˣڿ
ѧȦǸ޶ۣȫ֮ĿѧĻϲȦ
Ȧ֧۱ϻȦֻҪѧĻվͳˡڿѧȦ

(XYS20110403)

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ȳӡϮߵĿ

ߣypli

ΪԱƪĵһоǣΪ֮յ
ߣпѧ˼˸ݲܵӰ졣ΪҪ
ѧĵĲͬ㣬ΪѧĿ϶Ҫµ㣬ֻΪ
ռǳеоɹȻԱоɹԸɣ
ֹΪǳϮġ

ȻûпЩ£һЩ£Դ
Ƕ˵Ϯ㲻ϡ߸ов߻Ѱ䶯֮ѽ

(XYS20110403)

˿(www.xys.org)(xys5.dxiong.com)(www.xinyusi.info)(xys2.dropin.org)

Ф˸Ц

ߣ

2011322յļձһƪΪۡŷ 
Фκ޶˶²(Ф)ǲƽġ
Ф˲εıǶԷɵĲΡΪФͱʾ˾
һ¼ŬڸıһˡıһµḶ̌û
塪׷ķΣǲ̫˾ˡҿʵ
ˡ

Фȥһ塱ñӡ

ҵǣǼձҪŵФڽܼ߲ɷʱ
˲ʶ࣬ȻĿŵغҲоΪйķҲ
ǸЦйýҲǸЦФ̸¼:;
Դ2011328¿챨4棩˾һ¼
Ŭ˸Ц

ФƹҲΪ֮ǰֶͨΣ߹
ӣεҥͨ;Ҳֻù
ˡФ̸¼:;ҲԴ2011328
¿챨4棩

Ф˵Ϲ֮ǰФ人Ժ߷Ӿͻ
ʤߣ÷Ժ˵ӷӵʻлԪоԷ
˵ȷǲ

ФҲ˴ǰף뷽ϮԼ޹ءñ
̾ǻۣʱӷʹ޷ڴЩ
֤ǿŵģЩ뷽ͷزʶ֪ס
ҪûФ,˭šΪʲôӲ˵ΪʲôҪñ
ܷ粢øס

ûмʱסЩӷǶ¹ͬˣһҧ
ߡФ޹أФ治ð졣Ϊıߡ
ʵϻ裨ФһҧԼȿģϻ費һɶ
¡Ұ 2010-09-22 13:40:43 

Фûϵ˿ٹжڵƻ
Ҫȥٷӱٰ·ɻͱ̾ˡҲ뵽
ûճֵ֤ݣǲȡִʩġ

Ф׵ʵǾӱϻ˴õĽ
Ƿӻַ֧ӵġФҪƲ
ФһЩ֧ڴĸ

Ф׵ʵڣֻϷΪ
Լݣ֮ǰĺϲ˴ ѧǰһֱң
ʵڿȥˣ˵Ҫȥӡ˵ˣûԴ˵һ
ң׵ý壬˵ϵûһƪûҥġ

ýҥҲ˵˼ҡжͼФǮף
Ф˵˵ԻΪƾǰ˵ڱ
ٰءͰ˵Ҳǵĺôȥͷӣ
Щл̰ٵĺѧȡ̰Ϊ졣

ڷͷȷʵФ˴ʵǰФֻ
Ӳͦ;Ҳջָ˾ء˾
⵽֪ʶصĲФ⵽֪ʶز


ǵķǻȫФһҲд壬
ζñΪФҲ޹

ڷͷϮΪФָʹФ̶
߷һǣǿɷ޹ġ TOM,COM Ϯ
ӷӳ޹λйע Դ ɽ-ɽ̱ 
20100924 04:35:56Ȼʱ֪ǵݾһ
˶Էͷ˶֡
Ҳ̣Թձ߲ɷʱȴ˵ģͨ
ά׵ľάȨţФȡ˷ʽһҪԭ򡣡(Ф
,ݹʮԹѧ֮䡷2010-10-25 11:17:36
Դ:йѱ)
ЦһЩ˲ʵȻ˵ļٻФ
ʾйķΡФŮʿ̸(ľ-2010-10-21 
12:29:09)

ФйķΣǵΪǡǡսйķ
Ρ

2010827գԺٿȫ¼ұҪָ
ҪȺֱӼලȨ֧ýΥ߲
Ϊع⡣

2010828գϮ÷֮

Ժ2011328գйξ־ƽͺ
巨ξеڶʮߴμѧϰڼѧϰʱָ:ȫ
巨ξ񣬣http://t.cn/hBAJFY»£յ磩

ФڴǰʴʣսΡ

Ӧһɺϣ͹ЧܲǶԷξһֶԿ

ФĿ޷ͣһЩ˹أФ̾кֹЩ
ۿ֤

⵽ǸʲôĹ?һ˵᷽Υ! ()  ˹
 (0ֽ) 10/10 18:30ſƽ̳

Фй֪ʶӵάȨӢۡξǣֻ  (111
ֽ) 10/10 20:59 (118755)ſƽ̳

ûĺ飬˵ö֮Ϊ 09/22 01:13 ſ
̳ 

εµĽѵ,Ҫ뷽ʬҲĻ,
ô?ͽ: ˹  2010-09-22 04:28:01ſƽ̳ 

֧ĺҽФڣɨӣظ 
31λѧͬԮФҽĹ֮硾jhq1947  2010-9-30 
20:34:50 ˵

ڷڴѹҽתȷı֣Ѿ֤й
ĵˣļëϯ˵ģǵ˷ԵģǾҪӵ
ǵӵģǾҪԡĽ̵ȻФ˽⣬Ҳ֧
ظ 31λѧͬԮФҽĹ֮硾zsx98898 
 2010-9-30 23:21:39 ˵

Фҽ˴߹ҲΪþ
ǰʿԺ߹巴
й뵳ڴǴǵϻΪAĿ
֮ؽʧΪݣظ 31λ
ѧͬԮФҽĹ֮硾ԭ֮  2010-9-30 
21:46:06 ˵

˵ǾФڳҩԺ󴸷ûҪһͽ
 (143ֽ) 10/10 20:30 (118735)ſƽ̳ 

ҿֻҪ˭ǵ˾ͿԴ򣬴ҲãҪΪ
˵˵ѣĸдôˣɳġڽ
ФʵһѵӦö֮ԷݵĽֻʹ
ñ˺ӣỹʲô

ֵǣФսУһЩӦӦýδһʣ
ýΪ֮Ŀ˽ФΪӢۡ෴ʱ
̴ӡĩˣȻֶԴٷ׿гЧķӵΧФ
Цôˡ

ѵⲻһֹ󣿲ܲ˼嵱ע

201142ա

[]һЩФػζͶˣФ̾ڼ䣬ڮ
̾ʱǵĲۣ  
ԺȺỹڣå ſƽ̳ ͽ:  
2010-09-22 01:02 
أФߵĿԺܴ ſƽ̳ͽ: petscan 
 2010-09-22 06:47:33
ڿƼҪ֤練ơ Щ죬һ
 ſƽ̳ ͽ:   2010-09-22 21:42:35
Ф˾ ſƽ̳ ͽߣpetscan2010-09-3 05:12  
ȱҧɵ petscan (109ֽ) 09/23 10:46 (113207)
ľ_(ѧѧϵܵĲ)[ת]Evan KassǷ
ı¼( 2010-09-26 21:36)
˷֣ФΪѵ(2010-09-27 11:56)ʵ
(Գơ1983ҵͬҽƴѧֻпƼѧͬҽѧԺΪУ
83˶ʿ86ʿ
Ф˵Ļ,ҿڻһ ҶƵж̫,
һֱûӦ,,Ф˵ɷ޹,Фڱ,Ҳ˵,
Фͬѧͷй,ʲôǩ,ʲô,ǻŵһ
ֻȡ. 
˵Ǹ߻õıҲԺֶξ  (513ֽ) 
09/23 21:46 (113369
˵Фڡҩˣ̿ФҲ
ûߡӦ򱱾飬ûʦڳĿڹǷǷġ
ƽ̳ ͽ:   2010-09-28 21:07:44
Фαݣһ׻õִ ſƽ̳ ͽߣ 
2010-09-25 08:06)
ǿǴ𱱾˷˰˵ǮƦ ſƽ̳ ͽߣС
ѧ   2010-09-25 10:03:47
Ѱ: ۶Ѳڱƹ (ҾڸФҩ ſƽ̳ ͽߣ
 2010-09-24 16:49)

һȺ ()  Ѳ (0ֽ) 09/25 22:17 (114085)
TMDһȺЩһҹ ſƽ̳ 
: »  2010-10-12 17:35:52)
һ˶ܿıýȴԶФſ
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