Pharmacokinetic Study


We offer sponsor comprehensive ADME and pharmacokinetic evaluation and optimization services for entire drug pipelines, supporting their needs from early-stage drug development through to regulatory submissions. Our company has established an animal experimentation platform that complies with AAALAC standards. A professional research team and state-of-the-art equipment lay the foundation for providing high-quality services to our sponsor.

Research Content      
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1. In vitro ADME studies

Evaluate the ADME properties and potential drug-drug interaction information of candidate drugs, and, in combination with the drug’s characteristics and actual needs, establish an effective analytical method.

a. Physicochemical properties—solubility, partition coefficient, chemical stability, plasma stability, and plasma protein binding;

b. In vitro drug metabolism studies—species differences in liver microsomes and hepatocytes, identification of CYP450 metabolic phenotypes, and identification of metabolites;

C. Biofilm Permeability—Caco-2 Cells, PAMPA;

d. Drug interactions—CYP enzyme induction and inhibition, time-dependent inhibition.

2. In vivo ADME and pharmacokinetic studies

Our team leader has extensive experience in preclinical pharmacokinetic studies of biotechnology, gene and cell therapy drugs—particularly small-molecule drugs. We are well-versed in the risk factors that may affect data quality across different matrices, enabling us to proactively mitigate risks. Moreover, when encountering potential risk factors, we can promptly identify and address them, thereby enhancing efficiency while ensuring high-quality results.

a. Animal species: rodents, dogs, miniature pigs, and non-human primates;

b. Route of administration: intravenous, oral, subcutaneous, intraperitoneal, intramuscular, and topical;

c. Matrix types: plasma, serum, whole blood, urine, stool, and various tissues, etc.

 

3. Metabolite Identification and Material Balance

Studying in vivo biotransformation provides crucial information for predicting the metabolic behavior and safety of small-molecule drugs in the human body.

a. Content: Analysis and determination of metabolic products, as well as metabolic pathways;

b. Animal species: Rodents;

c. Evaluation: Bile, excretion rate.

4. Analytical evaluation of the test substance

The core members of the Analytical Testing Department have years of analytical experience and can provide customers with:

Services including test article preparation, solvent screening, and test article analysis.

 

More fields


Medicine

As an institution in Shaanxi Province that has obtained NMPA drug GLP certification and completed its qualification re-examination and scope expansion in 2024, Guorui Yinuo has built a “global + domestic” dual-compliance service capability in the pharmaceutical sector.

Veterinary Drug

The one-stop service platform for veterinary drugs—GLP/GCP—is a specialized service provider that offers an integrated solution—from non-clinical evaluation to clinical trials and registration submission—aligned with both the Ministry of Agriculture and Rural Affairs’ GLP/GCP standards for veterinary drugs and the international OECD GLP standards, covering the entire R&D process for veterinary pharmaceuticals. At its core, this platform addresses the key pain points faced by companies, including long R&D cycles, high compliance barriers, and fragmented resources.

Pesticide

As the only organization in the Northwest region to have obtained OECD GLP certification in the pesticide field, Guorui Yinuo passed the international assessment with a zero-defect record. Relying on its compliance credentials, comprehensive technological capabilities across the entire value chain, and high-standard laboratory platform, Guorui Yinuo provides integrated solutions for global pesticide companies—from research and development all the way through registration.

Chemical substances

Relying on the OECD GLP zero-defect certification qualification, chemical test data can be globally recognized and simultaneously comply with both domestic and international chemical regulatory requirements as well as relevant requirements of the Ministry of Ecology and Environment, efficiently supporting needs such as chemical registration and export declarations.

Guo Rui Xin Chuang

Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. is an independent, third-party clinical preclinical safety evaluation research institution for medical devices. It was registered and established in June 2020 in the Airport New City and is currently the most comprehensive medical device safety evaluation institution in Northwest China. The company primarily provides product safety evaluation services to R&D enterprises specializing in Class II and Class III medical devices.

Hua Xin Yi Nuo

A full-process technology empowerment platform from target discovery to IND submission

Early Toxicity Prediction and Screening

Early toxicity screening is an essential and indispensable step in the new drug development process. Early termination of compounds that show no development potential can save sponsor substantial amounts of manpower, resources, and time. We offer sponsor comprehensive early toxicity screening services, including early genotoxicity assessment, early general toxicity assessment, and early reproductive and developmental toxicity assessment.

Pharmacodynamic studies

We are equipped with specialized instruments and devices, including flow cytometers, microplate readers, fluorescence microscopes, and PCR machines. These resources enable us to establish animal models for diseases affecting the tumor, cardiovascular, respiratory, metabolic, and urinary systems, and to conduct comprehensive and systematic preclinical studies on drug efficacy and mechanisms at multiple levels.

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