Page 80 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

iv. Comet assay
2. In vivo studies
i. Micronuclei in erythrocytes (in blood and
bone marrow)
ii. Chromosome aberrations in metaphase
cells in bone marrow
t
-
i
e
n
i
g
l
y
a
t

o
i
x
u
c
c
e
t
S Single-acute toxicity
i. Rodent
ii. Non-rodent
e
e
p
a
e
a
8
2
(

d

t
y
d
e
R Repeated dose (28 days) )

o
s
s
d
i. Rodent
ii. Non-rodent
d

(
d
e
s
o
e
t
R Repeated dose (90 days) )

p
y
a
d
e
a
9
s
0
e
i. Rodent
ii. Non-rodent
1

/
h
s
y
r
)
a
e
d
n

m
o
s
e
o
(
t
6

t
e
d
e
R Repeated dose (6 months/1 year)
a
e
p

i. Rodent
ii. Non-rodent

i
t
y

n
a
C Carcinogenicity (Expected clinical use is
n
r
g
i
o
i
e
c
c
continuous for at least 6 months)

e
t
i
y
r
i

c
p
o
u
e
d

i
t
c
v
t
o
x
R Reproductive toxicity (Depending on study
population: Male, female, embryo-fetal (prior to
Phase III))
19 Specialized Toxicity Studies 1. Local tolerance (eg skin/eyes/GIT etc)
2. Hepatotoxicity
3. Phototoxicity
4. Immunotoxicity
5. Juvenile animal toxicity
6. Abuse toxicity
20 Assessment In Human (Clinical) 1. Estimation of initial safety and tolerability
2. ADME study
3. PK/PD study
4. Efficacy and safety profiling
5. Confirmatory study of efficacy
6. Primary endpoints identification (Please
state)
7. Documentation:
i. Clinical study reports
ii. Published clinical papers
iii. Latest periodic safety update report
(PSUR)

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64 NIH Guidelines for Conducting Research in MOH, 2021