Regulatory Strategies
and Safety
Assessment
General Toxicology Study

General toxicology studies, which can provide reference for the conduct of various clinical trials and marketing of drugs, are the most basic content of preclinical safety assessment of drugs. TriApex provides professional and product-specific general toxicity study services to ensure the clinical safe medication. 

Service Advantages

1. Professional team:

TriApex has over one hundred experts and laboratory technicians with rich toxicology experience to provide standard and scientific study design, and professional data collection, analysis and evaluation services. We have a professional quality assurance department and project management team to ensure the conduct of high-quality and efficient studies.

2. Case-by-case service:

TriApex can provide scientific and case-by-case study designs based on product characteristics.

3. Diversified services:

TriApex can provide various studies of special routes of administration (such as Ocular administration, intrathecal injection, and percutaneous administration) in various animal species. 

Service Capacities

Study 

Test System

Route of Administration

Biological Sample Collection

Single dose toxicity study

Repeated toxicity study

Non-human primates (cynomolgus monkey, rhesus monkey, etc.)

Rodents (rats, mice, guinea pigs, golden hamsters, etc.)

Rabbits, Beagle dogs, miniature pigs, etc.


Conventional routes of administration: intravenous (injection, infusion), oral (gavage, intranasal, oral capsules, etc.), subcutaneous injection, intramuscular injection, etc.

Special routes of administration: intraocular (eye drop, intravitreal injection, subretinal injection, suprachoroidal injection, etc.), intranasal administration, percutaneous administration, intracavitary administration (intracranial, articular cavity, intra tumor), etc.


Blood, urine, feces tissue (paraffin, frozen and other special treatments), aqueous humor collection, cerebrospinal fluid collection, liver tissue biopsy, etc.


Applications

TriApex can identify the safe dose range and toxicity profiles of different drugs, predict risks in clinical drug use, and provide important basis for clinical trials and drug marketing.

Project Experience

TriApex has conducted general toxicity tests of hundreds of drugs, including new chemical entities (including small nucleic acid drugs), biologics (antibody drugs, ADC, etc.), and cell/gene therapies. We have supported IND approvals of various drugs.