Non-GLP Safety Evaluation

Non-Good Laboratory Practice (Non-GLP) safety evaluation studies are conducted in a laboratory setting using experimental systems to assess the safety of drugs. These studies involve clinical observations of animals (typically mice) during the administration process, dynamic monitoring of clinical indicators, terminal necropsy and pathological evaluation, and cytokine detection. The results provide a toxicity evaluation to support preclinical studies of drug candidates. We offer efficient, high-quality, and flexible Non-GLP early safety evaluation services, providing data support and decision-making recommendations for the development of new drug candidates. We support multiple animal species (rats/mice, rabbits, guinea pigs, beagles, monkeys) and routes of administration (intravenous injection, oral gavage, subcutaneous injection, intradermal injection, intraperitoneal injection, intramuscular injection, intranasal administration, dermal administration, intravitreal injection, intratracheal administration, etc.). Furthermore, we can integrate the safety data with the candidate compound's bioactivity, efficacy, and pharmacokinetic data to provide comprehensive development and decision-making recommendations.

I. Technical Principle:

Non-clinical safety studies expose test subjects to the toxic effects of a test article through toxicological assays, in order to indicate the clinical safety of the test article. Through different toxicological tests, based on the dose/extent of exposure to the test article, the route of administration, the duration of administration, the symptoms and nature of the toxic reactions that occur, the target organs found in pathological examinations, and whether the toxic reactions/toxic damage are reversible, the toxic reactions are qualitatively and/or quantitatively exposed. This allows for the extrapolation of a safe reference dose and safe range for clinical trials, thereby predicting potential human toxicity that may occur during clinical drug use, in order to develop clinical monitoring indicators and prevention/control measures. Furthermore, the characteristics of the proposed indications, the intended patient population, and other factors are comprehensively considered to weigh the risks and benefits, and to determine whether to proceed to the corresponding stage of clinical research. The basic contents of non-clinical safety evaluation include safety pharmacology (general pharmacology), single-dose toxicity (acute toxicity), repeated-dose toxicity (long-term toxicity), genotoxicity, reproductive toxicity, carcinogenicity, dependence, and special toxicity (allergy, local irritation, hemolysis), etc.

II. Services Offered:

1. Single-Dose Dose Escalation Toxicity Exploration: Evaluate the toxic reactions of a single dose at different dose levels.

2. Multiple Repeated-Dose Toxicity Study: Evaluate the toxic reactions of repeated dosing at different dose levels, as well as the cumulative toxicity of the drug.

3. Dose Range Finding (DRF): Determine the toxic dose range of the drug, providing a basis for dose selection for subsequent studies.

4. Local Toxicity Test: Evaluate the toxic reactions of the drug after local administration.

5. Toxicokinetics/Toxicokinetic (TK) Assessment: Study the absorption, distribution, metabolism, and excretion processes of the drug in the body, as well as the relationship between toxic reactions and drug concentrations.

We can also integrate the safety data with the candidate compound's bioactivity, efficacy, and pharmacokinetic data to provide comprehensive development and decision-making recommendations.

III. Animal Species:

Rats/mice, rabbits, guinea pigs, beagles, monkeys

IV. Routes of Administration:

Intravenous injection, oral gavage, subcutaneous injection, intradermal injection, intraperitoneal injection, intramuscular injection, intranasal administration, dermal administration, intravitreal injection, intratracheal administration, etc.