Veterinary products, animal health and veterinary pharmaceuticals
CiToxLAB – Your one-stop CRO for animal health
CiToxLAB has developed a partnership with CER and Transpharm to form a center of excellence for pharmaceuticals and other veterinary products, covering veterinary pharmaceutical toxicology and safety evaluation services. We pool our skills, knowledge and experience to offer complete packages based on regulatory requirements for players in the animal health and veterinary pharmaceuticals industry.
Our teams perform safety studies in farm and companion animals. We offer attractive lead-times for testing your veterinary products and pharmaceuticals in target species.
With 40 years of experience in pharmaceutical safety assessment, we provide a complete range of services to evaluate the safety of your pharmaceuticals and other veterinary products in compliance with the guidelines.
Our center of excellence combines flexibility and a wealth of technical expertise to make us a partner of choice for your animal health and veterinary pharmaceuticals safety evaluation programs .
We have experts who advise and accompany your project :
- Establish the studies required to meet current regulations
- Design your protocols according to compound properties
- Develop and validate appropriate bioanalytical methods and techniques for matrix samples
Target animal safety and proof of concept
- Customized clinical and pharmacological experimental models
- Compound tolerance (systemic and local)
- PK/PD integration for veterinary drug proof of concept and dosing regimen optimization
We can perform a full range of studies, including single and multiple doses, by traditional and unusual administration routes for your animal health products and veterinary pharmaceuticals. Our study directors ensure that your studies receive the care and attention they deserve and provide you with high quality reports and reliable data interpretation. Animals are housed in dedicated areas and their welfare is one of our major concerns; protocols are submitted for ethics approval. You benefit from our 40 years of experience in pharmacological safety assessment, our state of the art facilities and back-up services, and of course the pooled experience of the center of excellence experts.
Customized preclinical animal models
We offer studies for the development and validation of customized clinical and pharmacological experimental animal models. These include complex models such as target animals for sparse samples and experimentally induced disease (infectious and non-infectious). Development is based on target animals described in the literature or derived from existing models in other species.
Pharmacology, toxicokinetics and efficacy
Integrated pharmacokinetics of animal health products and veterinary pharmaceuticals intended for use in farm or companion animals can be determined following intravenous, intramuscular, oral or topical administration.
- Pharmacological profile, EC50 determination from in vivo/in vitro models
- Microbiological profiles (MIC, MBC, MPC, Kill kinetic profiles, FIC index, Antibiotic Drug interactions in vitro)
- Absorption, Distribution, Metabolism and Elimination (ADME) profiles based on plasma, urine, bile, synovial and milk samples, following IV, IM, SQ, PO, Imam, topical administration.
- In vitro metabolism, genomics applied to drug metabolism (CYP induction / inhibition by mRNA assay, ABC transporters)
- In vitro models for topical absorption (skin, teat duct)
- Radiolabelled substances in target animals up to 20 kg
- Unlabeled products in all target species
- Bioavailability and kinetic profiles after repeated administration (maintenance of therapeutic concentrations, PK/PD validation of therapeutic regimen
- PK/PD integration
- In compliance with current guidelines (FDA, EU)
- Parallel or cross-over designs
- More complex models available, such as three-phase designs, models for sparse samples
Detailed biodistribution data can be required for animal health products and veterinary pharmaceuticals by regulatory authorities. Our extensive experience in toxicology combined with our expertise in genomics enables us to offer you robust biodistribution studies in agreement with current regulations.
Samples of diverse biological matrices, including tissues, plasma, urine, bile, milk and eggs can be used to investigate biodistribution. Our suitably qualified detection system (qPCR) and genomics-specific necropsy procedures enable us to detect as little as five copies of gene or cell DNA in any tissue or fluid in any species.
Depletion in tissues, milk, eggs and other biological matrices
All studies in compliance with VICH :
- GL 46: metabolic profile in laboratory animal species, including rats, mice, dogs, etc.
- GL 47: radiolabelled compounds in animals up to 20 kg of body weight
- GL 48: withdrawal time determination in all common target animal species
- GL 49: development and validation of HPLC, LC/MS/MS, LC-ICP/MS, GC/MS, RIA methods
We propose customized models for local tolerance (e.g. injection site, spot on, topical application) using biopsies, biomarkers, marker clearance profiles and drug interactions.
All studies are based on VICH GL43.
- Including voluntary acceptance for chewable tablets, palatable oral forms, etc.
- In compliance with current guidelines
Development and reproduction
We routinely perform standard reprotoxicity studies according to OECD guidelines for animal health and veterinary pharmaceuticals, backed up by extensive historical data. Our experts can advise you about study design, choice of vehicle, dose setting and all the other aspects of this specialization.
Fertility, embryo-fetotoxicity, teratogenicity, peri / post-natality studies can be performed in most target animal species, including dogs, cats, pigs, and other species on demand.
Toxicity and immunology studies provide the safety evaluation data required for new animal health vaccines. Packages can include stability, dose response, efficacy testing, injection site reaction, safety studies and immunogenicity. A number of factors are taken into account for study design, and our experts can help and advise you on all aspects of regulatory requirements to ensure that your vaccine package is relevant and cost effective.