The pharmacologists, toxicologists and study monitors at PHDS have experience in a variety of compounds and therapeutic areas. Our nonclinical resources are dedicated to getting the project to first-in-man studies. We place and monitor studies; obtain competitive bids with comparisons based on critical milestones; and design and review study protocols, considering dose selection, animal models, regimen, overall design and regulatory compliance.
PHDS has expertise in the following areas (our toxicology services are non-GLP):
l Primary and secondary pharmacology
l General toxicology (acute, subacute, subchronic and chronic)
l Special toxicology
l Genetic toxicology
l Reproductive and developmental toxicology
l Carcinogenicity, including the use of alternative models
l Safety pharmacology
l Absorption, distribution, metabolism and excretion (ADME) data
Safety Pharmacology
Safety pharmacology plays a critical role in the pharmaceutical industry, by providing valuable insight into a drug's potential adverse effects, preview what may be observed clinically and provide essential information about likely side effects on the major physiological systems of the body.
At PHDS, we understand your requirements for safety pharmacology testing in the changing environment of drug development. Our industry-leading scientists are innovative and investigative, and focus on improving existing models and developing new ones. Our broad GLP service offering enhances our ability to provide a complete range of pharmacology services, allowing full integration into a safety assessment program.
Toxicology
Species Available:
l Small to Medium Animals: rabbit, mouse, rat and guinea pig
l Large Animals: canine, nonhuman primate, mini-pig
Route of Administration:
l Oral administration includes Gavage, Dietary, Drinking Water, Capsule
l Parenteral administration includes Continuous Infusion, Intraperitoneal, Intravenous,
l Intramuscular, Subcutaneous and Intravitreal administration
l Rectal, Vaginal administration
l Other administration includes Implant, Nasogastric, Intranasal, Dermal, Ocular
General Toxicology Studies
l Single dose
l Repeated dose
l Dose Range Finding
Immunogenicity Studies
Carcinogenicity Studies
Safety Pharmacology
l Cardiovascular System（telemetry test）
l Central Nervous System
l Respiratory System (telemetry test)
Developmental and Reproductive Toxicology
l Fertility (Rat)
l Embryo-Fetal Development (Rat & Rabbit)
l Prenatal and Postnatal Development (Rat)
Genetic Toxicology
l In vitro Mammalian Cell Chromosome Aberration Test
l Ames Test
l Mouse Marrow Micronucleus Test
l TK Gene Mutation Assay
l Comet test
Irritation, Allergy and Hemolysis Tests
l Venous stimulation test
l Muscle stimulation test
l Skin irritation test
l Allergy test
l Passive anaphylaxis test
l In vitro hemolysis test