Unit 1 Topic ICH

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H Guide tines

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Page No.
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Guide lise

Relatdtb
DEaty
cnical Shodieg
in-vibro-1rVivo n Humau
pre clinito/tudiy SubsTB
alatet enDoxiiig Gpod tlluien
chemio
phasmacuilico
LCarinogenidty
rekedira19)utiu
FDeLe
2epone PUwary
Qualiy PuAany
N
A r e Lros-
tobikA Cutg lepiy
unfoqnely
inta cne 'sf_ke
SE CAtigoils
Mel DRA
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ESTEE
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Dale: 2022
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ualit, uidetiesKnow As-Senies


This Ore o mcludes qwidelina on Conduct
SHablity uclies, gudeliney_dehning
&elenadt hsahtd r impuiikA dLting
Ltto 1CH Gwdeae
IA-IE Stabilk
Aralytic Valilalin
GSA-R3D Umpuntu

hakmacopoeias
aRstGuality Bictecknalogical trduh
peit'cntiin
z GOod Manufa chusingliactiy
hasmaLesier Denelopment ne
uoll Riek Managemen
PhasmautialRWalig Syslem
Denlloprneut 2 Monufacturt e{ Du
Suh J-ameCR
ycle Management
s Continuoui Manudachung
1 Ana ltital oulur Denulypmen Sub y F

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