Drug toxicology and safety evaluation

The drug toxicity research and safety evaluation center is composed of a group of experienced professional scientific research teams. It has established a safety evaluation system in line with international standards. The experimental research follows the guidance and responsibilities of nmpa, ICH and FDA, and provides high-quality and efficient drug non clinical safety evaluation services.

Advantageous Service


1. Pharmacodynamics and toxicology of reproductive system

2. Reproductive and developmental toxicity test of non-human primates

3. Safety evaluation of pediatric drugs



Distribution of Functional Area

Total area

8500



Pathology room


It can undertake experimental pathology (teaching and scientific research) research services, routine non-clinical safety evaluation tests, support the establishment of animal models of pharmacodynamic departments, and has complete pathological research facilities and equipment to carry out histopathological examination of experimental animals such as mice, rats, guinea pigs, rabbits, dogs and non-human primates, including pathological gross anatomy of experimental animals, conventional paraffin sections, tissue section making, H-E staining, special staining, immunoenzyme histochemical staining, immunofluorescence staining, pathological diagnosis, image acquisition, qualitative and semi quantitative analysis.


1. In vivo perfusion fixation techniques of various experimental animals (mice, rats, dogs, rabbits, monkeys)

2. Anatomy of various experimental animals (mice, rats, dogs, rabbits, monkeys, miniature pigs)

3. Paraffin tissue, frozen tissue, electron microscope sample, body fluid collection, cell smear and scraping

4. Paraffin section

5. Various staining techniques: H-E staining, special staining, immunohistochemical staining and immunofluorescence staining

6. Pathology services

(1) Toxicological test diagnosis (single dose toxicity test, repeated dose toxicity test, carcinogenic test, etc.)

(2) Efficacy test (diagnosis of fatty liver model, liver fibrosis model and Xinguan efficacy model)

(3) Tissue distribution test (undertaking stem cell and gene therapy products)



Clinical test room

1. Core service contents


(1) General test




Name



Project


Instrument


Specimen type


Serum biochemical test


ASTALT ALPTPALBBUNGLU

T-CHOTGCKGGTCREAT-BIL


Roche Cobas 6000

Sysmex BX-3010


Serum




Blood routine test (five categories)




WBC、RBC、HGB、HCT、MCV、MCH、MCHC、PLT、

NEUT#、LYMPH#、MONO#、EO#、BASO#、RET# 、

NEUT%、LYMPH%、MONO%、EO%、BASO%、RET%



Sysmex XN-1000


EDTA-2K anticoagulant



Four items of coagulation



APTT、PT、TT、FIB



Sysmex CS-2400

Werfen ACL TOP300 CTS


Plasma



Electrolyte



K+Na+Cl-Ca2+pH



Roche Cobas 6000

Meizhou Kangli k-lite8



Serum




ELISA detection




Hormone and other tests (depending on specific indicators)




BIO-RAD



Plasma/Serum





⑵Immune correlation test


Name

Project

Instrument

Specimen type

Specimen type


IgG、IgM、IgA


Roche Cobas 6000

Sysmex BX-3010




Serum



Lymphocyte subsets




Test of T, B, NK cell subsets/test of regulatory T cells, etc




BD Calibur

BD Celesta



EDTA-2K anticoagulant



Cytokine test



IL-2、IL-4、IL-5、IL-6、TNF-α、IFN-γ



BD Calibur

BD Celesta


Serum/Plasma




2. Orientation of undertaking


(1) It can undertake clinical detection indicators in the non clinical toxicological test of drugs so as to provide reference basis for the non clinical safety evaluation of drugs;

(2) Detection of clinical related indexes of experimental animals to provide reference basis for evaluating the health status of animals.

 



3.Advantages

(1) It has passed the laboratory capability verification of the Central Inspection Institute;

(2)Most of the inspectors are experienced GLP clinical inspectors;

(3)Most instruments are imported and have a high market share. All testing instruments have been calibrated by the provincial metrology institute or a third-party calibration institution and passed the performance verification;

(4) Strict laboratory quality control system;

(5) Standardized reagent management system.

 



● Macromolecular analysis room

● Small molecule analysis room

● Test article analysis room


  • MSD

  • Flow Cytometry