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Non-GLP Nonclinical Safety Evaluation

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Genevoyager has extensive experience in nonclinical safety evaluation of drugs and can provide standardized and personalized trial design proposals according to customer needs, as well as individual or comprehensive sets of nonclinical safety research data to support new drug applications.

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General toxicity

Single-dose toxicity

Repeated-dose toxicity: 7 days, 14 days, 28 days, 13 weeks, 26 weeks, 39 weeks

Species: mice, rats, beagle dogs, cynomolgus monkeys, rabbits, miniature pigs

Administration routes: oral, injection (intravenous/intraperitoneal/subcutaneous), dermal, ocular, etc.

Safety pharmacology

Central nervous system (mice, rats)

Respiratory system (mice, rats, dogs, monkeys)

Cardiovascular system (dogs, monkeys)

hERG assay (in vitro)

Reproductive and developmental toxicity

Fertility and early embryonic development toxicity test (Phase I) (rats)

Embryo-fetal development toxicity test (Phase II) (rats, rabbits)

Perinatal toxicity test (Phase III) (rats)

Juvenile animal toxicity test (rats)

Genetic toxicity

Ames test (in vitro)

Micronucleus test (in vitro/in vivo)

Chromosomal aberration test (in vitro)

Mouse lymphoma assay (in vitro)

 Special toxicity

Local irritation test (skin, blood vessels, eyes)

Sensitization test (active, passive)

Hemolytic test (in vitro)

In vitro phototoxicity test

Ophthalmic toxicity test

Administration routes

● Intracerebral injection

● Gastric administration

● Oral mucosal administration

● Nasal instillation

● Intrathecal administration

● Intrathoracic injection

● Intraperitoneal injection

● Subcutaneous injection

● Intradermal injection

● Intramuscular injection

● Transdermal administration

● Rectal administration

● Vaginal administration

● Intra-articular administration

● Infraorbital venous plexus administration

● Tail vein injection

● Intrathecal injection

● Intravitreal injection

● Subretinal administration


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E-mail: hui.wang@genevoyager.com

China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com

ABOUT US TECHNOLOGY PLATFORM

US: 3675 Market Street, Suite 200, Philadelphia, PA19104 Tel: +1 (215) 205-6963 | +086 027-65023363
E-mail: hui.wang@genevoyager.com

China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com

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