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Animal Service
Animal Service
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Drug Discovery Research
 We conduct a wide range of studies supporting discovery and development programs for our Sponsors. We provides early evaluation services on the efficiency and safety of active pharmaceutical ingredients (API), it includes (but not limited to)
-       Efficiency screening
-       Bioavailability and metabolic screening
-       Toxicity screening
We provide a full scope of services such as gene therapy drugs, antibodies, cytokines, protein drugs and chemical drugs in vitro and in vivo screening, preclinical study on effectiveness evaluation, human disease modeling and treatment. We have a package of advanced preclinical technology and platform on effectiveness evaluation, commit to the drug development and submission.
-       Pharmacodynamics on Anti-tumor Drug (in vitro and invivo)
-       Drug Evaluation on Antibody
-       Immunobinding Test with Cell and Tissue
-       Drug Evaluation on Hematopoietic/Coagulation/Diabetes
-       Evaluation on Somatic Cell Therapy/Immunotherapy
-       Carbohydrate Tolerance Test, Transgenic for Diabetes Animal Model
-       Drug Evaluation on Physical Dependence and Psychologic Dependence
-       Cell-surface Marker Analysis, Cell Field Planting, Cell Differentiation, Cytokine Analysis.
In vivo model:
We provides preclinical in vivo models for assessment of drug and we also work with our Sponsors to develop new models
Our models include (but are not limited to)
-       Tumors
-       Mycoardial infarction
-       Cerebral ischemia
-       Granulocytopenia
-       Thrombopenia
-       GVHD
-       Renal failure
-       Inflammation
-       Arthritis
We conduct wide range pre-clinical & clinical studies supporting drug discovery and development Method
development and method validation
Chemicals (HPLC, LC-MS/MS, Online-SPE-MS/MS)
Biologics (ELISA, EIA, ECL, RT-PCR, In situ hybridization)
Plasma kinetics
Excretion Balance
Quantitative Tissue Distribution
Metabolite ID
Non-Compartmental Analysis Model, Compartmental Analysis Model
PK/TK parameters estimation
Address preclinical-to-clinical
PK-PD modeling & simulation
Ascending does/repeat dose
TA formulation & Analysis
TA are stored and handled by specific trained staff
Formulation: Gavage, parenteral, dietary, topical, I.V infusion
Analytical chemistry:
Item: Concentration, homogeneity, stability
Methods: HPLC-UV, UV-VIS, LC-MS/MS, RT-PCR, ELISA, et al.
In Vitro Studies
Species variation in metabolism (Hepatocytes & microsomes)
Drug-drug interactions (CYP450 inhibition and induction)
Drug absorption and kinetics (Caco-2, MDCK)
Protein binding
CYP450 reaction phenotyping
Dermal absorption
Metabolite stability, profile, ID
Enzyme assay
Immune tissues and morphologic pathology
Immunochemistry (ELISAa, IgG, C3)
Protein toxicokinetics
Immunogenicity, aniti-drug Ab, Neutralizing Ab, cytokine quantitation
Flow cytometry
Molecular biology assays, including real-time PCR assays
Radio analysis (Iodine-125)
Protein & peptide radio label
Excretion studies
Mass balance studies
Metabolite separation (SHPLC-online)
Clinical Trails
To support Phase I through Phase IV clinical trials
Develop and validate robust analytical method
Sample analyses
PK modeling
Safety evaluation
Our drug safety evaluation research services offer dedicated expertise in
-       Safety Pharmacology (Central Nervous System, Cardiovascular System, Respiratory System, Renal/Urinary System, Gastrointestinal System)
-       General Toxicology (Single- and repeated-dose toxicity studies in mice, rats, rabbits, dogs, monkeys and others as required)
-       Genetic Toxicology (Ames, chromosomal aberration and micronucleus assays)
-       Carcinogenicity (Rodent life-time bioassays and transgenic mice study)
-       Developmental and Reproductive Toxicology (Three segments)
-       Immunogenicity and immunotoxicity study
-       Special Toxicity (hemolysis test, topical and local toxicity tests)
Clinical Research
We help you initiate your clinical trials in support of your IND and NDA filings and marketing approvals. We provide safety assessments and efficacy studies for a spectrum of diseases including HIV.
A partial list of our services includes the following:
-       Protocol Design
-       CRF Design
-       Investigator’s Selection
-       Investigator’s Brochure preparation
-       Trial Organization and Management
-       Trial Monitoring and Auditing
-       SAE Reporting
-       Data Collecting and Analysis
-       Clinical Report Preparation
Scientific and regulatory service
Our Scientific and Regulatory Service Team, with extensive experience in US FDA regulation, has forged a unique appreciation of the product-specific complexities of drug development while providing our clients with a comprehensive scientific and regulatory strategy.
For each client, we---
-       Designs studies and prepares customized protocols and reports for a spectrum of nonclinical pharmacology and toxicology studies in compliance with both USFDA and FDA regulation.
-       Plans and implements strategies, serves as your representative to both SFDA and FDA, and provide application support for IND, NDA, ANDA, or DMF.
Our Advantage
-       Meets international standards
AAALAC accredited
US FDA GLP inspected
SFDA GLP certified
-       Stable operation for 17 years with experienced staff of long tenure
-       One of the most experienced CRO in China providing full spectrum of preclinical services
490+ IND/NDA submitted to SFDA
1300+ studies conducted
-       International standard facility (AAALAC accreditation, Euro-standard primate housing, international standard functional lab)
-       Experts in both SFDA and FDA regulations
Reports accepted for SFDA and US FDA IND/NDA filings
- Private CRO with financial and management stability allowing strong focus on core business

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