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Drug safety and effectiveness

Pharmacodynamics:

Pony Biomedical has a strong research and development team of pharmacodynamic animal models, and has formed a research and development echelon dominated by masters and doctors. The team focuses on the research and development of animal models of human diseases (animal modeling). We has successfully developed more than 200 animal models of human diseases to provide research objects and platforms for efficacy screening, drug metabolism, non-GLP safety evaluation, life science experiments, and transformation of medical scientific and technological achievements.

Animal model of pharmacodynamics in vivo:

Cardiovascular and cerebrovascular diseases: cerebral ischemia, myocardial ischemia, traumatic brain injury, cerebral edema, atherosclerosis, chronic heart failure model, MCAO;
Nervous system diseases: depression, sciatic nerve injury, epilepsy model;
Digestive system diseases: alcoholic liver injury, nonalcoholic fatty liver, acute chronic liver injury, liver fibrosis, acute gastritis, gastric ulcer, colitis;
Respiratory related system diseases: pulmonary fibrosis, acute lung injury, acute chronic pharyngitis, oral ulcer;
docrine and metabolic diseases: T1DM, T2DM, hyperlipidemia, hyperuricemia model, obesity, DN;
Inflammatory and immune diseases: anti inflammatory and analgesic drug screening model, arthritis, gout;
Reproductive system diseases: prostate hyperplasia, endometriosis, polycystic ovary syndrome;
Skin related diseases: full-thickness skin wound (cut), skin scald model (deep II degree scald);
Anti tumor efficacy: CDX, PDX model;
Carcinogenic/teratogenic: rats.

In vitro pharmacodynamic animal model:

Nerve model: Nerve injury model;
Tumor model: anti angiogenesis, in vitro anti-tumor efficacy, in vitro anti drug resistance, migration model, efficacy screening, tumor cell proliferation;
Cardiovascular model: endothelial injury model.

Pharmacokinetics
Our company is equipped with advanced analytical instrument. The pharmacokinetics and bioanalysis team has rich experimental experience in the analysis of chemical drugs and biological drugs, and can provide a comprehensive services for in vitro ADME, in vivo ADME and toxicokinetics analysis. The study will be designed in accordance with FDA, NMPA and ICH guidelines. The study can adopt mice, rats, guinea pigs, rabbits, dogs, monkeys and other animals for various administration methods such as intravenous, inhalation, gavage, percutaneous, muscular and subcutaneous administration. Biological substrates such as animal organs, plasma, whole blood, serum and cerebrospinal fluid are collected. Company experimental facilities, study execution, instruments and equipment and personnel achieve the GLP standard.

The main services currently are as follows:

In vitro ADME
In vivo ADMEBioanalysis
Intestinal absorption / Pgp binding test
Material BalanceSmall Molecule Bioanalysis
Plasma protein binding rate testTissue Distribution ResearchLarge Molecule Bioanalysis
Blood plasma ratio
Excretion Research
CYP450 inhibition testsMetabolite identification
CYP450 induction testsHaemodynamics Research
Hepatocyte metabolic stability tests

Plasma stability tests

Liver microsomal metabolism tests

Drug non-clinical safety evaluation

General toxicology
Single dose toxicity test
Repeated dose toxicity test
Dose range finding test
Toxicokinetic test
Development and reproductive toxicologyfertility and early embryo development toxicity test
embryo-fetal development toxicity test
Perinatal toxicity test
Genetic toxicologyin vitro Chromosome aberration test of mammalian cells
Ames test
Mouse bone marrow micronucleus test
Local toxicity studyVascular irritation test
Muscle irritation test
Skin irritation test
Active systemic anaphylaxis
Passive cutaneous anaphylaxis
In vitro hemolysis test


Founded in 2002 and headquartered in Haidian District, Beijing, the company has developed into a large-scale comprehensive inspection and certification group with nearly 30 large-scale experimental bases, nearly 100 wholly-owned subsidiaries and service network all over the country.
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