Toxicology
20 Years of Global Toxicology Excellence
QPS offers a wide range of toxicity, toxicokinetics, and drug metabolism and pharmacokinetics (DMPK) 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 no regulatory studies for your investigational new drug (IND) filing are 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.
Proven Quality Standards for 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 20 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, and dogs.
Statistics:
- 1,800 Successfully Completed GLP Studies
- 31 Dossiers Compiled for US FDA IND Submissions
- 31 Client Audits with Satisfactory Outcomes
- 7 Available Animal Species in One Location
Using toxicokinetics, we can determine the systemic exposure of lead compounds as part of single-dose and repeated-dose toxicology studies. Toxicokinetics also allow us to determine the therapeutic index of the lead compound in DMPK studies.
GENETIC TOXICOLOGY
Custom-Built Genetic Toxicology Studies
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 program planning and individual study design for your pharmaceutical and biotechnology products.
Capabilities include:
- Fertility
- 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
Industry-Leading Histopathology Services
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
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
Leadership
Globally Recognized Toxicology Research Scientists
Charlene Chen
