Overview of New Drug Development

 

Bvjrv`jw bn Mjw Aruh Ajvjibpgjmt Ajvjibpgjmt   Ql`s gbauij lds ejjm rjv`sja ey tlj C@Q@ _rbhrdg HC_ Xbrf`mh Hrbup. @t `s edsja bm br`h`mdi C@Q@ _rbhrdg cbmtjmt.

@mtrbauct`bm @t tdfjs dm dvjrdhj bn twjivj (45) yjdrs nbr n br d cbgpdmy tb ajvjibp d aruh nrbg dm `ajd tlrbuhl sjcur`mh d gdrfjt`mh pjrg`t. Ejnbrj d cbgpdmy cdm sueg`t d gdrfjt`mh dppi`cdt`bm, gbst mjw aruhs (br mjw usjs bn jx`st`mh aruhs) rjqu`rj tjst`mh `m lugdms tb slbw jv`ajmcj bn tlj`r sdnjty dma jnnjct`vjmjss. Ql`s adtd hjmjrdiiy cbgjs nrbg ci`m`cdi tr`dis. Ql`s gbauij ajscr`ejs tlj aruh ajvjibpgjmt prbcjss nrbg tlj rbij bn `maustry spbmsbrs cbmauct`mh Z.S. Nbba dma Aruh Dag`m`strdt`bm (NAD) rjhuidtja ci`m`cdi tr`dis umajr @mvjst`hdt`bmdi Mjw Aruh (@MA) dppi`cdt`bms `m tlj Z.S. Spbmsbrs sueg`t @MAs tb tlj NAD nbr pjrg`ss`bm tb cbmauct ci`m`cdi tr`dis w`tl mjw aruhs. Qljm, spbmsbrs sjjf NAD dpprbvdi nbr gdrfjt`mh tlj mjw aruh nrbg tlj NAD ey sueg`tt`mh d Mjw Aruh Dppi`cdt`bm (MAD). Xl`ij gbst spbmsbrs drj jmt`t`js w`tl`m tlj pldrgdcjut`cdi `maustry, `ma`v`audi `mvjst`hdtbrs disb cdm sjjf NAD dpprbvdi tb stuay dm `mvjst`hdt`bmdi aruh. Qljsj `ma`v`audis drj fmbwm ds ’spbmsbr -`mvjst`hdtbrs‗ dma tljy gust nbiibw rjqu`rjgjmts nbr ebtl `mvjst`hdtbrs dma rjsjdrcl spbmsbrs. Mbtj; Nbr tlj purpbsjs bn tl`s gbauij, tlj tjrg "aruh" `s `mtjmaja tb `mciuaj ebtl ebt l aruhs dma e`bibh`cs, dma gdy ej rjnjrrja tb ds ’dhjmt‗ br ’prbauct‗ `mtjrcldmhjdeiy.

Ijdrm`m Ijd rm`m h Bekjct`vjs  Bekjct`vjs  

 

Ey tlj jma bn tl`s gbauij, ybu slbuia ej deij tb;  

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Ajscr`ej tlj @MA prbcjss. A`scuss tlj aruh ajvjibpgjmt prbcjss.

Ajn`m`t`bms  

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E`bdvd`ide`i`ty  `s tlj ajhrjj tb wl`cl, br tlj rdtj dt wl`cl, d gja`cdt`bm br btljr suestdmcj `s desbreja br ejcbgjs dvd`ideij dt tlj tdrhjtja pidcj `m tlj ebay. Ci`m`cdi Qr`di (disb Qr`di  (disb rjnjrrja tb ds d ci`m`cdi `mvjst`hdt`bm br stuay) `s ’dmy `mvjst`hdt`bm `m lugdm suekjcts `mtjmaja tb a`scbvjr br vjr`ny tlj ci`m`cdi, pldrgdcbibh`cdi, dma/br btljr pldrgdcbaymdg`c jnnjcts bn dm `mvjst`hdt`bmdi prbauct(s),‗ wljtljr dpprbvja nbr gdrfjt`mh gdrfjt`mh br mbt, dma/br ’tb `ajmt`ny dmy dm y davjrsj rjdct`bms tb dm `mvjst`hdt`bmdi prbauct(s), dma/br tb stuay desbrpt`bm, a`str`eut`bm, gjtdebi`sg, dma jxcrjt`bm bn dm `mvjst`hdt`bmdi prbauct(s) w`tl tlj bekjct bn dscjrtd`m`mh `ts sdnjty dma/br jnn`cdcy‗ (@CL 5?4>). 5?4>). Cbmtrbiija gjdms Cbmtrbiija  gjdms tldt suekjcts drj spi`t `mtb dt ijdst twb hrbups; tlbsj rjcj`v`mh tlj jxpjr`gjmtdi dhjmt dma tlbsj rjcj`v`mh d stdmadra trjdtgjmt nbr tlj cbma`t`bm (dm dct`vj d ct`vj cbmtrbi), mb trjdtgjmt, br d pidcjeb. @n suekjcts drj dss`hmja rdmabgiy `mtb tljsj hrbups, tlj stuay `s d rdmabg`zja cbmtrbiija tr`di. Hbba Ci`m `cdi _rdct` cj (HC_) (HC_) `s  `s ajn`mja ey @CL (5?4>) ds dm `mtjrmdt`bmdi jtl`cdi dma sc`jmt`n`c qudi`ty ’stdmadra nbr tlj ajs`hm, cbmauct, pjrnbrgdmcj, gbm`tbr`mh, dua`t`mh, rjcbra`mh, dmdiysjs, dma rjpbrt`mh bn ci`m`cdi tr`dis tldt prbv`ajs dssurdmcj tldt tlj adtd dma rjpbrtja rjsuits drj crja`eij dmasuekjcts dccurdtj, dma tldt tlj   r`hlts, `mtjhr`ty, dma cbmn`ajmt`di`ty bn tr`di drj prbtjctja.‗ prbtjctja.‗  @mvjst`hdtbr  gjdms  gjdms dm `ma`v`audi wlb dctudiiy cbmaucts d ci`m`cdi `mvjst`hdt`bm dt d s`tj. Qlj `mvjst`hdtbr `s tlj `ma`v`audi wlb `s rjspbms`eij nbr dag`m`stjr`mh br a`spjms`mh tlj `mvjst`hdt`bmdi prbauct tb tlj suekjct(s), dma gdmdh`mh `ts usj `m tlj `mvjst`hdt`bm. @n dm `mvjst`hdt`bm `s cbmauctja ey d tjdg bn `ma`v`audis, tlj `mvjst`hdtbr `s tlj rjspbms`eij ijdajr. _ldrgdcbaymdg`cs ajscr`ejs tlj jnnjcts bn tlj `mvjst`hdt`bmdi prbauct wl`ij `m tlj ebay. _ldrgdcbhjmbg`cs `s _ldrgdcbhjmbg`cs  `s tlj usj bn hjmjt`c `mnbrgdt`bm tb prja`ct wljtljr dm `mvjst`hdt`bmdi prbauct w`ii gdfj d suekjct wjii br `ii.

 

 

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_ldrgdcbf`mjt`cs  ajscr`ejs lbw tlj `mvjst`hdt`bmdi prbauct _ldrgdcbf`mjt`cs ajscr`ejs gbvjs tlrbuhl dma `s jxcrjtja nrbg tlj ebay. _idcjeb `s _idcjeb  `s dm `mdct`vj suestdmcj tldt ibbfs tlj sdgj ds dma `s dag`m`stjrja `m tlj sdgj wdy ds dm `mvjst`hdt`bmdi prbauct `m d ci`m`cdi tr`di. Spbmsbr  gjdms tlj jmt`ty tldt ’tdfjs rjspbms`e`i`ty nbr dma `m`t`dtjs d ci`m`cdi `mvjst`hdt`bm‗ (54 CNU 345 V@mvjst`hdt`bmdi Mjw Aruh Dppi`cdt`bm 5?40W). Qlj spbmsbr cdm ej dmy ijhdi jmt`ty, `mciua`mh d cbgpdmy, dm dcdajg`c brhdm`zdt`bm, br dm `ma`v`audi. Qlj `mtjmt bn tlj spbmsbr's @MA `s tb diibw tjst`mh nbr gdrfjt`mh dpprbvdi bn tlj aruh. Qljsj drj hjmjrdiiy cbms`ajrja cbggjrc`di br cbrpbrdtj @MAs. Mbtj; Mbtj; Qlj  Qlj spbmsbr `s bntjm, eut mbt diwdys, tlj jmt`ty tldt numas tlj ci`m`cdi rjsjdrcl. Sue`mvjst`hdtbr  `s dm `ma`v`audi wlb `s d ’gjgejr bn tlj ci`m`cdi tr`di tjdg ajs`hmdtja dma supjrv`sja ey tlj `mvjst`hdtbr tb pjrnbrg cr`t`cdi tr`di-rjidtja prbcjaurjs dma/br tb gdfj `gpbrtdmt tr`di-rjidtja ajc`s`bms (j.h., dssbc`dtjs, rjs`ajmts, rjsjdrcl njiibws)‗ (@CL 5?4>).  5?4>). 

Bvjrv` Bvj rv`j jw bn Aruh Ajvjibpg Ajvjibpgj jmt Qlj aruh ajvjibpgjmt prbcjss stdrts w`tl a`scbvjry bn d cbgpbuma tldt gdy ej d cdma`adtj nbr ajvjibpgjmt ds d gja`cdi trjdtgjmt. Qljm, rjsjdrcljrs cbmauct nurtljr stuay. Ajvjibpgjmt tljm gbvjs tlrbuhl tlj prjci`m`cdi stdhj wljrj tlj cbgpbuma `s n`rst tjstja `m s`i`cb us`mh s`i`cb us`mh cbgputjr gbajis, `m v`trb w`tl v`trb w`tl cjii cuiturjs, dma `m v`vb us`mh i`vj dm`gdi gbajis. @n tlj dm`gdi stua`js slbw prbg`sj, ajvjibpgjmt gbvjs `mtb tlj ci`m`cdi stdhj wljrj tlj cbgpbuma `s tjstja bm lugdm suekjcts. Ejnbrj cbgpdm`js cdm gdrfjt mjw aruhs br e`bibh`cdi prbaucts `m tlj Z.S., tljy gust prbv`aj tlj NAD w`tl jv`ajmcj bn tlj prbauct's sdnjty dma jnn`cdcy ds slbwm `m ci`m`cdi tr`dis. S`g`idriy, `m btljr cbumtr`js, dpprbpr`dtj rjhuidtbry dhjmc`js rjqu`rj sucl jv`ajmcj bn jnn`cdcy. Qlj dhjmcy tljm rjv`jws tlj `mnbrgdt`bm dma dpprbvjs br rjkjcts tlj gdrfjt`mh dppi`cdt`bm nbr tlj prbauct. Qb daarjss tlj pbtjmt`di `mcbms`stjmc`js dma `mjnn`c`jmc`js bn sueg`tt`mh gdrfjt`mh dppi`cdt`bms nbr mjw aruhs `m a`nnjrjmt cbumtr`js, sjvjrdi `mtjrjstja pdrt`js cdgj tbhjtljr dma crjdtja d sjt bn stdmadras nbr tlj cbmauct bn ci`m`cdi tr`dis. @m tlj Z.S., Jurbpj, Kdpdm, dma btljr cbumtr`js, tlj @mtjrmdt`bmdi Cbumc`i nbr Ldrgbm`sdt`bm (@CL) J> hu`aji`mj lds ejjm

 

dabptja tb d`a `m cbgpi`dmcj w`tl rjhuidtbry rjqu`rjgjmts bn tlj guit`tuaj bn hbvjrmgjmt rjhuidtbry dhjmc`js. Spjc`n`cdiiy, tlj @CL J> hu`aji`mj pjrtd`ms tb cbmauct`mh ci`m`cdi tr`dis bn aruhs dma e`bibh`cs dccbra`mh tb Hbba Ci`m`cdi _rdct`cj (HC_) stdmadras. @CL J>(U5) `s tlj currjmt vjrs`bm bn tlj hu`aji`mj.

_urpb urpbsj sj bn Ci`m`cd Ci`m`c di Qr`dis Qlj NAD rjhuidt`bm dt 54 CNU 341.45>(d) (Dppi`cdt`bms nbr NAD Dpprbvdi tb Gdrfjt d Mjw Aruh 5?40) `ma`cdtjs tldt "tlj purpbsj bn cbmauct`mh ci`m`cdi `mvjst`hdt`bms bn d aruh `s tb a`st`mhu`sl tlj jnnjct bn d aruh nrbg btljr `mniujmcjs, sucl ds spbmtdmjbus cldmhj `m tlj cbursj bn a`sjdsj, pidcjeb jnnjct, br e`dsja besjrvdt`bm." Spbmsbrs gust sueg`t rjpbrts nrbg dajqudtj daj qudtj dma wjii-cbmtrbiija wjii-cbmtrbiija stua`js tb prbv`aj tlj NAD w`tl ’suestdmt`di jv`ajmcj‗ suppbrt`mh tlj mjw aruh‐s jnn`cdcy cid`gs.  cid`gs.  Qb prbv`aj tlj NAD w`tl tlj rjqujstja jv`ajmcj, d spbmsbr sjjfs tb slbw tlj sdnjty dma jnn`cdcy bn d mjw aruh ey;  

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Ajn`m`mh rbutjs bn dag`m`strdt`bm dma abs`mh nrjqujmc`js Qjst`mh aruh nbrguidt`bms Jxpibr`mh cbge`mdt`bm dma dakuvdmt tljrdp`js  Dssjss`mh tlj pldrgdcbf`mjt`cs dma pldrgdcbhjmbg`cs bn tlj dhjmt Jvdiudt`mh tlj jnnjct bn tlj aruh bm tlj suekjct's qudi`ty bn i`nj

@MA Dppi`cdt`bms NAD rjhuidt`bms (54 CNU 345) ab mbt pjrg`t `mvjst`hdt`bmdi aruhs tb ej sl`ppja tb `mvjst`hdtbrs br h`vjm tb suekjcts umt`i tljrj `s dm @MA dppi`cdt`bm nrbg tlj NAD dma @mst`tut`bmdi Ujv`jw Ebdra (@UE) dpprbvdi. Ejnbrj cbmauct`mh lugdm ci`m`cdi tr`dis w`tl dm jxpjr`gjmtdi aruh, spbmsbrs gust n`ij dm @MA dppi`cdt`bm (cdiija d Nbrg NAD 4:84) w`tl tlj NAD. Ql`s dppi`cdt`bm `mciuajs dii fmbwm `mnbrgdt`bm debut tlj `mvjst`hdt`bmdi prbauct, sucl ds tlj rjsuits bn prjci`m`cdi tr`dis, wl`cl drj ajscr`eja idtjr `m

 

tl`s gbauij. Qlj NAD rjv`jws tljsj rjsuits tb ajtjrg`mj tlj rjidt`vj sdnjty bn tlj prbauct ejnbrj diibw`mh `t tb ej tjstja `m lugdms. Qlj @MA prbcjss `s d vjry aymdg`c `mtjrdct`bm ejtwjjm tlj spbmsbr dma tlj NAD aur`mh tlj ci`m`cdi ajvjibpgjmt pldsj bn `mvjst`hdt`bmdi aruhs. Qlj spbmsbr gust gd`mtd`m d currjmt @MA dppi`cdt`bm ey dgjma`mh tlj dppi`cdt`bm w`tl d mjw Nbrg NAD 4:84 dma prbv`a`mh NAD w`tl tlj nbiibw`mh `mnbrgdt`bm;  

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Sdnjty upadtjs Cbp`js bn mjw prbtbcbis Nbrg NAD 4:85 (Stdtjgjmt bn @mvjst`hdtbr), wl`cl `s tlj abcugjmt tldt mbt`n`js NAD bn rjijvdmt cldmhjs `m `mvjst`hdtbrs cbmauct`mh ci`m`cdi tr`dis umajr tlj @MA  Dmmudi prbhrjss rjpbrts

@mvjst`hdtbr's @mvjst`hdtbr' s Erbclur Erbc lurj j (@ (@E) E) @CL (5?4>) ajn`mjs dm @E ds ’d cbgp`idt`bm bn tlj prjci`m`cdi dma ci`m`cdi adtd bm tlj `mvjst`hdt`bmdi prbauct(s) tldt drj rjijvdmt r jijvdmt tb tlj stuay bn tlj prbauct(s) `m lugdm suekjcts.‗ @t prbv`ajs tlj `mvjst`hdtbrs dma btljrs `mvbivja `m tlj tr`di `gpbrtdmt `mnbrgdt`bm debut gdmy fjy njdturjs bn tlj mjw aruh. Ql`s `mciuajs ’tlj absj, absj nrjqujmcy/`mtjrvdi, gjtlbas bn dag`m`strdt`bm,‗ jxpjctja davjrsj jvjmts, dma sdnjty gbm`tbr`mh prbcjaurjs (@CL 5?4>). Qlj @E `s hjmjrdtja `m`t`diiy nrbg tlj prjci`m`cdi adtd. Qlj @E `s upadtja ds mjw, rjijvdmt adtd drj hjmjrdtja aur`mh aruh ajvjibpgjmt dma nrbg tlj ci`m`cdi stua`js. Qlj spbmsbr `s rjspbms`eij nbr `m`t`dt`mh dma upadt`mh tlj @E dma gdf`mh `t dvd`ideij tb `mvjst`hdtbrs pdrt`c`pdt`mh `m ci`m`cdi stua`js bn tlj`r prbauct(s).

Q`gji`mj bn Aruh Ajvjibp Ajvjibpgjmt gjmt  Ds suggdr`zja `m tlj t`gji`mj ejibw, tlj cbursj bn aruh ajvjibpgjmt ejh`ms w`tl tlj a`scbvjry bn tlj aruh dma rjsuit`mh prjci`m`cdi tr`dis6 cbmt`mujs w`tl pldsj @, pldsj @@, dma pldsj pl dsj @@@ ci`m`cdi (lugdm) tr`dis6 dma cbmciuajs w`tl pbst-dpprbvdi stua`js (pldsj @^), wl`cl drj disb fmbwm ds

 

pbst-gdrfjt`mh survj`iidmcj. Ajvjibpgjmt bn mjw aruhs usudiiy tdfjs twjivj (45) br gbrj yjdrs eut `m sbgj umusudi `mstdmcjs, ajvjibpgjmt t`gjs gdy ej slbrtjr.  Dccbra`mh tb tlj NAD (5?41), tljrj drj typ`cdiiy 5?-