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Aokpli`e my

Er# Qglvn Kurtgy Cncducenppn

KMMQ) KE) KMN) A@LK

G`ne) Ailclani ]`s`nrag Pclt

R`rsocni LE sglvulcelnByngoo#aok

Ociy jor Nane`kla Rurpos` Ociy

Cot jor sni` or aokk`ralni us`

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Nii stnt`k`cts kne` lc tgls pr`s`ctntloc nr` p`rsocni#

Ky aurr`ct or jutur` `kpioy`r ls cot r`spocslmi` jor ncy

aocs`qu`ca`s#

Nii tg` lcjorkntloc sgnr`e ls jor nane`kla purpos`

Ps`rs wlii put tg`lr owc tgoufgt proa`ss nce e`alsloc to

us` tg` knt`rlni ns lt ls or wltg / wltgout koeljlantlocs#

Nutgor wlii cot m` r`spocslmi` jor ncy

aocs`qu`ca`s/enknf`s nrlslcf out oj tgls pr`s`ctntloc

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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C``e jor MN/M@ stuel`s

]`fuintory nutgorlty oc M@

Ov`rvl`w oj F`c`rni JEN r`aokk`centlocs

M@ nppronag`s4 LZLZA) Prlc`) RE) Ailclani) lc vltro

Elssoiutloc

Qukknry

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Iow aost k`elalc`s e`v`iopk`ct C``e oj tg` gour jor wgoi` worie

Qnj`ty nce `jjlanay oj tg`s` sgouie m` `stnmilsg`e jor f`ttlcf knrh`tlcf

nutgorlzntloc

JEN r`aokk`ces to e`t`rklc` rnt`/`xt`ct oj nmsorptloc oj `nag tg`rnp`utla

kol`ty jor

Rot`ctlni f`c`rla proeuats jor wglag tg`r` ls n r`j`r`ca` ilst`e eruf ']IE,

npprov`e jor knrh`tlcf lc PQ

Rot`ctlni c`w eruf proeuats 'c`w snits) eosnf` jorks, jor wglag ne`qunt`

ailclani stuel`s gnv` nir`ney m``c aoceuat`e

]`jorkuint`e eruf proeuats

@jj`atlv` Duiy >0) =22

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Ug` Pclt`e Qtnt`s Jooe) Eruf) nce Aosk`tla Nat 'JEAN,) `cnat`e lc > AJ],

Pce`r => AJ]) Rnrt 1=2 ls jor Mlonvnlinmlilty nce Mlo`qulvni`ca` ]`qulr`k`cts

Aknx ns lce`x oj rnt` oj nmsorptloc

NPA ns lce`x oj `xt`ct oj nmsorptloc

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7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Kost stuel`s us` g`nitgy corkni sumd`ats

JEN nshs tgnt motg kni`s nce j`kni`s m` `croii`e

Anc us` pntl`cts) lj tg`r` nr` snj`ty lssu`s

Ug` cukm`r oj sumd`ats ls mns`e oc pgnrknaohlc`tla

'RH, vnrlnmlilty

N M@ stuey oj n glfgiy vnrlnmi` eruf kny r`qulr`

`croiik`ct oj n inrf`r cukm`r oj sumd`ats

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Lj eruf pos`s n snj`ty rlsh to g`nitgy corknisumd`ats) kust stuey lc pntl`cts

@xnkpi`s Aioznplc`4 @vniunt` M@ lc n st`ney+stnt` stuey lc

saglzopgr`cla pntl`cts oc `stnmilsg`e r`flk`cs 's`` JENfulenca` oc Aioznplc` Unmi`ts,

@toposle`4 @vniunt` M@ ns tg` jlrst eos` oj n tr`ntk`ctayai` lc anca`r pntl`cts

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Mloncniytlani k`tgoeskust m`

vnilent`e Rr`+stuey Mloncniytlani K`tgoe Znilentloc sgouie e`t`rklc`

tg` joiiowlcf

Nssny s`i`atlvlty

Nssny pr`alsloc nce naaurnay

Qtnmlilty oj stor`e ncniyt`'s, 'l#`# eruf nce k`tnmoilt`) lj

nppilanmi`, lc vnrlous kntrla`s

]`aov`ry oj ncniyt`'s, nce lct`rcni stncenre

Nssny ilklt oj qunctltntloc 'IO^,

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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NPA ls e`t`rklc`e my tg` trnp`zoleni k`tgoe

Aknx 'nce aorr`spocelcf Uknx, ls e`t`rklc`e

cuk`rlaniiy

JEN r`qu`sts tgnt NPA2+t ) NPA2+nce Aknx k``t M@

arlt`rln

Nppilancts sgouie niso r`port H`i nce U>/=

Lj eruf gns n iocf U>/=) tg`c cot c`a`ssnry to

aniauint` NPA2+'niso H`i nce U>/=,

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Ps` NCOZN wltg two oc`+sle`e t`sts proa`eur` to stntlstlaniiy

ncniyz` M@ stuey entn

M@ arlt`rln nr` tgnt #=0

]oucelcf up or eowc ls cot p`rkltt`e

Uknx kny niso m` `vniunt`e) lj rnple ocs`t oj `jj`at ls

c`a`ssnry jor `jjlanay

@xnkpi`4 Cnprox`c Qoeluk @] Unmi`ts ']IE Cnpr`inc A] Unmi`ts,

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Kost s`csltlv` nce elsarlklcntlcf jork oj M@ stuey e`slfc

JEN r`qu`sts slcfi`+eos` jnstlcf M@ stuey jor nii syst`klaniiy

nvnlinmi`/natlv` erufs uci`ss pr`aiue`e jor snj`ty r`nsocs

@xnkpi`4 K`jioqulc` Unmi`ts) =02 kf

Jor r`nsocs oj snj`ty) inm`i r`aokk`ces tgnt pntl`cts tnh` oc juii

stoknag

Iocf gnij+ilj` eruf

JEN r`qu`sts Qlcfi` eos`) pnrnii`i e`slfc j`e M@ stuey ociy

Ps` n trucant`e NPA nt 6= gours

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Jor kost soile orni eosnf` jorks) spocsor sgouie aoceuat motg

jnstlcf * j`e M@ stuel`s

Eruf ls flv`c wltglc 12 klcut`s oj aocsuklcf n glfg+ jnt k`ni

K`ni sgouie provle` 722+>222 Hani lc totni nce nt i`nst 02% oj tg`

totni Hani jrok jnt

JEN pumilsg`s n stncenrelz`e k`ni e`sarlptloc

Coc+stncenrelz`e k`ni ls naa`ptnmi` lj k``ts totni Hani nce jnt Hani

arlt`rln

JEN elsaournf`s uslcf v`f`tnrlnc k`nis + kny cot proeua` snk`

`jj`ats ns coc+v`f`tnrlnc k`nis

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Jor lkk`elnt`+r`i`ns` 'L], proeuats) elatnt`e my JEN+

npprov`e Inm`i jor tg` ]IE

Lj inm`i aoctnlcs stnt`k`cts nmout `jj`at oj jooe oc

nmsorptloc or neklclstrntloc

Lj eruf anccot m` flv`c oc nc `kpty stoknag 'jor

snj`ty r`nsocs,

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Jor nii orniiy+neklclst`r`e koeljl`e+r`i`ns` 'K],orni eruf proeuats

E`iny`e+r`i`ns` 'E],

@xt`ce`e+r`i`ns` '@],

Uo aokpnr` pot`ctlni jor eos`+eukplcf

Cot c`a`ssnry to aoceuat j`e M@ stuel`s jor nii

str`cftgs oj K] proeuats

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Vg`c tg` inm`i nevls`s tgnt tg` eruf kust m`

tnh`c oc nc `kpty stoknag

Vg`c tg` inm`i knh`s co stnt`k`cts nmout `jj`at

oj jooe oc nmsorptloc or neklclstrntloc oj nc L]

proeuat

Vg`c tg` eruf ls ainssljl`e ns MAQ Ainss L eruf

'nppil`s ociy to L] proeuats,

Ainss L + Glfg R`rk`nmlilty) Glfg Qoiumlilty

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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Ilst`e lc => AJ] 1=2#=5) lc e`sa`celcf ore`r oj

naaurnay) s`csltlvlty) r`proeualmlilty

># Rgnrknaohlc`tla 'RH, stuey lc wglag erufaoca`ctrntlocs nr` k`nsur`e lc pinskn

+ Lc vltro+lc vlvoaorr`intloc 'LZLZA,

=# RH stuey lc wglag eruf aoca`ctrntlocs nr`

k`nsur`e lc urlc`

7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N

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1# Naut` pgnrknaoioflani `jj`at k`nsur`e ns n jucatloc oj

tlk` + M@ stuey wltg pgnrknaoeycnkla 'RE, `cepolcts

5# V`ii+aoctroii`e ailclani trlni lc gukncs 'M@ stuey wltg

ailclani `cepolcts,

0# Aurr`ctiy nvnlinmi` lc vltrot`st) naa`ptnmi` to JEN) tgnt

`csur`s mlonvnlinmlilty 'MN,

:# Ncy otg`r nppronag e``k`e ne`qunt` my JEN to

`stnmilsg MN or M@

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Ug`lc vltro

/lc vlvo

aorr`intloc 'LZLZA,

E`v`iop jorkuintlocs wltg eljj`rlcf r`i`ns` rnt`s nce

aorr`int` lc vltroelssoiutloc wltg lc vlvonmsorptloc

Lj nc LZLZA ls `stnmilsg`e) anc wnlv` lc vlvostuel`s lc sok`

alraukstnca`s

@vniunt` motg lct`rcni nce `xt`rcni pr`elatnmlilty

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Prlc` k`nsur`k`cts nr` npproprlnt` wg`c erufanccot m` r`ilnmiy k`nsur`e lc pinskn

@xnkpi`4 potnssluk agiorle`

Mns`ilc` lc miooe ls too glfg to p`rklt naaurnt`

k`nsur`k`ct

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Ug` JEN naa`pts RE `jj`at k`tgoes to npprov`f`c`rla toplani aortlaost`role eruf proeuats

Ugls nppronag ls mns`e oc nmlilty oj aortlaost`roles to

proeua` vnsoaocstrlatloc or mincaglcf lc shlc

JEN gns n fulenca` oc tgls nppronag

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M@ stuel`s wltg ailclani `cepolcts

Jor eruf proeuats tgnt nr` cot syst`klaniiy nmsorm`e

@xnkpi`s

Uoplani eruf proeuats

Qok` ioaniiy natlcf FL eruf proeuats

E`slfcs nr` rnceoklz`e) milce`e) mninca`e) pnrnii`i

Rntl`cts r`a`lv` t`st) r`j`r`ca`) pina`mo

Rina`mo froup us`e to `csur` tgnt pntl`cts r`spoce to t`st nce

r`j`r`ca` proeuat

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Lc vltronppronag`s nr` niso us`e wltg ioaniiynatlcf eruf proeuats

Orni agoi`styrnklc` susp`cslocs) tnmi`ts) anpsui`s

Cnsni sprnys nce susp`cslocs

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C`w Rroposni

]`j`r`ca`+sani`e nv`rnf` M@ nppronag

Ugr``+p`rloe M@ stuey

Neklclst`r r`j`r`ca` proeuat twla`

Neklclst`r t`st proeuat oca`

Q`qu`ca`s4 U]]) ]U]) ]]U

M@ arlt`rln sani`e to r`j`r`ca` vnrlnmlilty

Motg NPA nce Aknx sgouie k``t M@ naa`ptnca` arlt`rln

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Q`t jortg lc => AJ] Rnrt 1=2 LZ soiutlocs

Orni soiutlocs

Coc+M@ str`cftgs oj soile orni eosnf` jorks

MAQ Ainss L erufs

E@QL erufs wltg co mlo`qulvni`ca` promi`ks

Out oj saop` oj tgls tnihE@QL Eruf @jjlanay Qnj`ty Lkpi`k`ctntloc Npprov`e oc mnsls oj snj ty ociy

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Ug` Elvlsloc oj Mlo`qulvni`ca` 'EM@, nt OFE

ls r`spocslmi` jor

e`t`rklclcf optlkni k`tgoe nce s`ttlcf sp`aljlantlocs jor

f`c`rla erufs

JEN k`tgoe us`e jor L] nce E] proeuats

Ans`+my+ans` k`tgoe e`v`iopk`ct jor @] eruf proeuats

Ps` elssoiutloc entn to support r`qu`sts jor

mlo+wnlv`rs oj coc+ mlo str`cftgs

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Ug` JEAN nce JEN r`fuintlocs flv` tg` JEN tg` i`fni nutgorlty

to r`qu`st M@ stuel`s

JEN posts fulenca`s oc M@ nppronag`s4

gttp4//www#jen#fov/ae`r/fulenca`/

Jor kost syst`klaniiy nvnlinmi`/natlv` f`c`rla erufs) JEN

r`qu`sts n slcfi`+eos` jnstlcf nce n slcfi`+ eos` j`e M@

stuey

Nppilancts anc r`qu`st wnlv`rs oj lc vlvot`stlcf provle`e tg`y

k``t JEN arlt`rln

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Elssoiutloc entnmns`4gttp4//www#naa`ssentn#jen#fov/sarlpts/ae`r/elssoiutloc/lce`x#ajk

Lcelvleuni proeuat M@ r`aokk`centlocs entnmns`4gttp4//www#jen#fov/ae`r/fulenca`/mlo`qulvni`ca`/e`jnuit#gtk

JEN fulenca`s4 gttp4//www#jen#fov/ae`r/fulenca`/ Orncf` mooh4 gttp4//www#jen#fov/ae`r/om/e`jnuit#gtk

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I`ng C# Vliilnksoc) Rg#E) Huie``p ]# Egnrlwni) Rg#E#) Mlo`qulvni`ca`

U`stlcf lc tg` P#Q# jor F`c`rla Eruf Rroeuats) Elvlsloc ojMlo`qulvni`ca`) Ojjla` oj F`c`rla Erufs) A`ct`r jor Eruf @vniuntlocnce ]`s`nrag) P#Q# Jooe nce Eruf Neklclstrntloc) =220':,4:06+72

Mlo`qulvni`ca` Nppronag`s jor Glfgiy Znrlnmi` Erufs nce ErufRroeuats# Gnlenr `t# ni#

Rgnrk# ]`s# =227 Dnc8 =0'>,4=16+5>#

Glfgiy Znrlnmi` Erufs4 Oms`rvntlocs jrok Mlo`qulvni`ca` EntnQumkltt`e to tg` JEN jor C`w F`c`rla Eruf# Envlt `t# ni# Ug` NNRQ

Dourcni=227 Knr8 >2'>,4>57+0:# @vniuntloc oj n Qanilcf Nppronag jor tg` Mlo`qulvni`ca` oj Glfgiy

Znrlnmi` Erufs# Gnlenr `t# ni# Ug` NNRQ Dourcni=227 Q`p8 >2'1,4502+

505#

gttp4//www#jen#fov/ae`r/fulenca`/

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Zlslt

www#ailcsys#aok

Aoctnat Er# Qglvn Kurtgy

sglvulcelnByngoo#aok

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