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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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7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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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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C``e jor MN/M@ stuel`s
]`fuintory nutgorlty oc M@
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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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kol`ty jor
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npprov`e jor knrh`tlcf lc PQ
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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
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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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
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'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
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@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
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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
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arlt`rln
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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
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Uknx kny niso m` `vniunt`e) lj rnple ocs`t oj `jj`at ls
c`a`ssnry jor `jjlanay
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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 s`csltlv` nce elsarlklcntlcf jork oj M@ stuey e`slfc
JEN r`qu`sts slcfi`+eos` jnstlcf M@ stuey jor nii syst`klaniiy
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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
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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
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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Jor lkk`elnt`+r`i`ns` 'L], proeuats) elatnt`e my JEN+
npprov`e Inm`i jor tg` ]IE
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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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str`cftgs oj K] proeuats
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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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
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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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1# Naut` pgnrknaoioflani `jj`at k`nsur`e ns n jucatloc oj
tlk` + M@ stuey wltg pgnrknaoeycnkla 'RE, `cepolcts
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`stnmilsg MN or M@
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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Ug`lc vltro
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aorr`intloc 'LZLZA,
E`v`iop jorkuintlocs wltg eljj`rlcf r`i`ns` rnt`s nce
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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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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`
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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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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
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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M@ stuel`s wltg ailclani `cepolcts
Jor eruf proeuats tgnt nr` cot syst`klaniiy nmsorm`e
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Uoplani eruf proeuats
Qok` ioaniiy natlcf FL eruf proeuats
E`slfcs nr` rnceoklz`e) milce`e) mninca`e) pnrnii`i
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Rina`mo froup us`e to `csur` tgnt pntl`cts r`spoce to t`st nce
r`j`r`ca` proeuat
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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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
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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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`
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M@ arlt`rln sani`e to r`j`r`ca` vnrlnmlilty
Motg NPA nce Aknx sgouie k``t M@ naa`ptnca` arlt`rln
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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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
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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Ug` Elvlsloc oj Mlo`qulvni`ca` 'EM@, nt OFE
ls r`spocslmi` jor
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f`c`rla erufs
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Ps` elssoiutloc entn to support r`qu`sts jor
mlo+wnlv`rs oj coc+ mlo str`cftgs
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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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
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stuey
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k``t JEN arlt`rln
7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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Elssoiutloc entnmns`4gttp4//www#naa`ssentn#jen#fov/sarlpts/ae`r/elssoiutloc/lce`x#ajk
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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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7/28/2019 Overview of FDA Guidelines for Conducting BA/BE Clinical Trials - Dr. Shiva Murthy. N
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Aoctnat Er# Qglvn Kurtgy
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