Toxicology

Our commitment is to provide you, our valued customers, with a fast and reliable route to clinical phase I-II studies.

We offer you a wide range of toxicity and DMPK studies as well as other preclinical safety tests that are essential for your preclinical drug development programs. As our valued client, you maximally benefit from our long track record of designing large and specialized in vivo studies.

Quality and flexibility are key factors in our work. We work closely together with you and ensure that no regulatory studies are overlooked that are required for your IND filing. As a direct result, we will design and execute the most cost effective development strategies for your drug candidates.

Toxicology Leadership Team

W
Walter Bee
Vice President and Global Head of Safety Assessment and Regulatory Affairs
C
Charlene Chen
Senior Director of Toxicology

General Toxicology

QPS offers a complete range of standard toxicology protocols designed for supporting submissions to international regulatory agencies.

With multiple test species available (including nonhuman primates), studies are overseen by Study Directors with vast experience gained from performing over 1000 GLP studies for local and international pharmaceutical and biotechnology companies within many different disease therapies in the past 12 years, thereby ensuring quality performance, delivery of high quality data as well as proper interpretation, review and reporting of every aspect of your study.

Our General Toxicology capabilities include:
  • Single Dose Toxicity Studies
  • Repeated Dose Toxicity Studies
    • Up to 180 days
    • Routes of administration: oral, intravenous (injection and infusion), intramuscular, subcutaneous, intraperitoneal and others
    • Animal species: mice, rats, guinea pigs, hamsters, rabbits and dogs

Reproductive Toxicology

QPS has been performing developmental and reproductive toxicity studies for pharmaceutical and biotechnology products for over 12 years. Using internationally recognized guidelines, including International Conference of Harmonization (ICH), we offer overall developmental and reproductive toxicology program planning and individual study design to conduct safety assessments for your pharmaceutical and biotechnology products.

Our embryo-fetal toxicity capabilities include:
  • Fertility
  • Teratology
  • Animal species: rat and rabbit 

Clinical Pathology

QPS's 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.

Our Clinical Pathology capabilities include:
  • Urine Analysis
  • Hematology
  • Serum Chemistry
  • Coagulation & Hemostasis
  • Microbiology & Immunology

Genetic Toxicology

Genetic toxicology studies are conducted early in the safety testing program of your pharmaceutical and biotechnology products. QPS conducts its 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..

Our Genetic Toxicology capabilities include:
  • Gene Mutation Assays
    • Ames Test
    • HPRT gene mutation assay
    • In Vitro mouse lymphoma assay
  • Cytogenetic Assays
    • Sister chromatid exchange assay
    • Chromosome aberration assay
    • Micronucleus Assays
  • Micronucleus Assay in CHO cells
    • Mouse micronucleus assay
  • Cell Transformation Assay
    • In Vitro cell transformation assay

Histopathology

Microscopic evaluation of tissues, coupled with clinical pathology data, remains a cornerstone of toxicological evaluation of your pharmaceutical and biotechnology products. Our group of experienced pathologists has an average of 12 years experience in the field. We have experience with any type of study from animal model evaluation, through preliminary non-GLP toxicity studies to formal GLP studies.

Our Histopathology capabilities include:
  • Tissue and Slide Preparation
  • Tissue Image
  • Pathology Consultation and Evaluation

Dermal Irritation and Contact Sensitization

Local Tolerance Testing

Evaluation of skin irritation and contact sensitizing of your test material is done by QPS to determine the potential to provoke ocular irritation, dermal irritation, or sensitization.

Our Dermal Irritation and Contact Sensitization capabilities include:
  • Irritation Studies
    • Eye irritation test
    • Dermal irritation test
    • Animal species: rabbit
  • Skin Sensitization Testing
    • Buehler test
    • Maximization test
    • Animal species: guinea pig
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