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.