DRUG DEVELOPMENT CONSULTING
Help our clients, especially the small drug development businesses or individuals, design and support nonclinical and early phase clinical development programs with an innovative and integrative strategy pertinent to the intended clinical indications.
Strategic Nonclinical Development
NONCLINICAL STUDY SERVICES
Our contracted nonclinical CRO is a GLP compliant laboratory. It has been inspected by the US FDA as well as the Chinese FDA, and has met all GLP regulatory requirements; all study data submitted to the US FDA have been accepted. All your nonclinical needs for drug development will be satisfied via one-stop shopping with the best quality and at a reasonable cost.
- Pharmacology Efficacy Models (in vitro and in vivo)
- Plasma Biomarker Analysis
- In vivomodels in both small and large animals
- 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)
- Carcinogenesis (Rodent life-time bioassays and transgenic mice study)
- Developmental and Reproductive Toxicology (Three segments)
- Special Toxicity (Immunogenicity study, hemolysis test, topical and local toxicity tests)
- Pharmacokinetics and Toxicokinetics
- Drug Exposure (AUC)
- PK and TK Parameters
- Bioequivalence/Bioavailability
- In vivo CYP Induction
- Formulation Assessment
- Toxicological Pathology
- Immunohistochemistry
- Histomorphometry
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