Safety Studies (Pharmaceuticals)

Single dose toxicity studies

Test Route of administration
Single dose toxicity study Oral
Percutaneous
Intravenous
Subcutaneous
Intramuscular
Intraperitoneal
Intrarectal
Oral mucosal

Repeated dose toxicity studies

Test Route of administration
Repeated dose toxicity study Oral
Percutaneous
Intravenous
Subcutaneous
Intramuscular
Intraperitoneal
Intrarectal
Oral mucosal

Reproductive and developmental toxicity studies

Test Route of administration
FEED study Oral
Transdermal
Intravenous
Subcutaneous
Intramuscular
Intraperitoneal
Intrarectal
Oral mucosal
PPND study
EFD study

Local irritation tests

Test
Primary skin irritation test
Eye irritation test
Cumulative skin irritation test
Vascular irritation test
Perivascular irritation test
Hemolysis test
Muscle irritation test
Subcutaneous irritation test
Rectal mucosal irritation test
Vaginal mucosal irritation test
Skin phototoxicity test

Antigenicity tests

Test Method
Skin sensitization test Adjuvant and Patch test
Maximization test
Buehler test
Skin photosensitization test Adjuvant and Strip test
Harbor Test
Antigenicity test

Safety Studies (Medical Devices)

Test

Cytotoxicity tests

Colony formation method
Elution test

Skin sensitization tests

Maximization Test
Adjuvant and Patch Test

Skin irritation test

Intradermal reaction test
Eye irritation test
LabCyte EPI-MODEL 24 SIT

General toxicity tests

Acute systemic toxicity test
Subacute toxicity test
Subchronic toxicity test
Chronic toxicity test

Genotoxicity tests

Reverse mutation test (Ames test)
Chromosomal aberration test
Micronucleus test (in vitro)
Micronucleus test (in vivo)

Hemocompatibility tests

Hemolysis test

Implantation tests

Test Implantation period
Short-term intramuscular implantation 1 week
4 weeks
Implantation in bone
Implantation in organ		 4 weeks
13 weeks
26 weeks
39 weeks
52 weeks
104 weeks
Stent implantation 4 weeks
13 weeks
26 weeks
39 weeks
52 weeks
Stent implantation 1 weeks
4 weeks
13 weeks

Others

Test Others
Use simulation test Use simulation / chronic toxicity combination test

Safety Studies (Regenerative Medical Products)

Test

General toxicity tests

General toxicity test

Safety pharmacology studies

Effects on clinical signs and behavior
Effects on the cardiovascular system
Effects on respiratory function

Tumorigenicity tests

Tumorigenicity test (in vivo)

Soft agar colony formation tests

Soft agar colony formation test (in vitro)