Toxicology
QPS offers a wide range of toxicity studies, as well as other preclinical safety tests that are essential for preclinical drug development programs. We have a long and successful track record of designing specialized in vivo studies.
Quality and flexibility are key factors as we work together to ensure that all regulatory studies for your investigational new drug (IND) filing are not overlooked. As a direct result, we will design and execute the most cost-effective development strategies for your drug candidates. Our commitment is to provide you with a fast and reliable route to clinical phase 1-2 studies.
GENERAL TOXICOLOGY
QPS offers a complete range of standard toxicology protocols designed for supporting submissions to international regulatory agencies. With multiple test species available, studies are overseen by Study Directors with vast experience based on thousands of studies conducted for pharmaceutical and biotechnology companies across many disease therapies over the past 25 years. We ensure quality performance, delivery of high-quality data, and proper interpretation, review, and reporting of every aspect of your study.
Capabilities include:
- Single-Dose Toxicity Studies
- Repeated-Dose Toxicity Studies
- Routes of administration: oral, intravenous (injection and infusion), intramuscular, subcutaneous, intraperitoneal, instillation, dermal, and others.
- Animal species: mice, rats, guinea pigs, hamsters, rabbits, dogs, and mini-pigs.
GENETIC TOXICOLOGY
Genetic toxicology studies are conducted early in the safety testing program of your pharmaceutical and biotechnology products. QPS conducts genetic toxicology studies in a tiered approach, starting with an Ames test and progressing to the conduct of mammalian cell and in vivo assays, which are designed to assess the toxicological relevance of any earlier observations.
Capabilities include:
- Gene Mutation Assays
Ames Test
In vitro Mouse Lymphoma Assay - Cytogenetic Assays
Chromosome Aberration Assay in Chinese Hamster Ovary (CHO) Cells
Micronucleus Assays in CHO Cells - Mouse Micronucleus Assay
REPRODUCTIVE TOXICOLOGY
QPS has been performing developmental and reproductive toxicity studies for pharmaceutical and biotechnology products for over 15 years. Following internationally recognized guidelines, including International Conference of Harmonization (ICH), we offer overall developmental and reproductive toxicology (segment II) program planning and individual study design for your pharmaceutical and biotechnology products.
Capabilities include:
- Teratology
- Animal Species: Rat and Rabbit
CLINICAL PATHOLOGY
Our experienced Clinical Pathology Group offers a complete range of laboratory testing services. Our laboratories are equipped to provide the highest level of support to your toxicology programs through leading-edge technologies, quality assurance measurements, and laboratory management programs.
Capabilities include:
- Urine Analysis
- Hematology
- Serum Chemistry
- Coagulation & Hemostasis
- Microbiology & Immunology
HISTOPATHOLOGY
Microscopic evaluation of tissues, coupled with clinical pathology data, remains a cornerstone of toxicological evaluation of your pharmaceutical and biotechnology products. Our board-certified pathologists have decades of experience in the field with any type of study from animal model evaluation, through preliminary non-good laboratory practices (GLP) toxicity studies to formal GLP studies.
Capabilities include:
- Tissue and Slide Preparation
- Tissue Image
- Sperm Analysis
- Pathology Consultation and Evaluation
BIOCOMPATIBILITY TEST FOR MEDICAL DEVICES
To support the biological evaluation of medical devices, we provide a range of tests following ISO-10993. With extensive experience in the study design and fast turn-around time, we provide high-quality data and reporting to meet your timeline for research and submission.
Capabilities include:
- Cytotoxicity
- Genotoxicity
- Sensitization and Irritation
- Hemocompatibility
- Implantation
- Reproductive and developmental toxicity
- Systemic toxicity studies
DERMAL IRRITATION AND CONTACT SENSITIZATION
Local Tolerance Testing
Evaluation of skin irritation and contact sensitizing of your test material is conducted by QPS to determine the potential to provoke ocular irritation, dermal irritation, or sensitization.
Capabilities include:
- Irritation Studies
Eye Irritation Test
Dermal Irritation Test
Animal Species: Rodent and Rabbit - Sensitization study in Guinea pigs
Leadership
Globally Recognized Toxicology Research Scientists
Charlene Chen
