Large Animal PK Study
Large Animal Pharmacokinetics
Large animal pharmacokinetic (PK) studies characterize drug exposure and disposition over time in non-rodent species after administration. These studies can provide information on systemic exposure, bioavailability, dose proportionality, tissue distribution, and other PK properties that help connect earlier discovery data with later preclinical development.
Large animal PK studies may be used to support species selection, dosing-regimen design, formulation or route-of-administration bridging, PK/PD interpretation, and planning for toxicology or other development studies. The appropriate species and study design depend on the therapeutic modality, target biology, formulation, route of administration, and the specific development question.
Large Animal PK Study Design and Integrated Support
WuXi Biology and Testing supports non-rodent PK studies across discovery and preclinical development, with species including canines, non-human primates (NHPs), swine, rabbits, and ferrets. Study designs can include single- or multiple-dose PK, parallel or crossover studies, absolute or relative bioavailability, formulation bridging, tissue distribution, excretion, and specialized dosing or sampling approaches.
Integrated support can connect in vivo PK with bioanalysis, preclinical formulation, metabolite profiling and identification, tissue distribution, clinical chemistry, pathology, and safety assessment when needed. This coordinated approach helps generate interpretable exposure data and supports decisions on candidate progression, dose selection, and subsequent development studies.
High Standards of Animal Welfare
At our facilities, we conduct animal studies with a strong commitment to animal welfare and ethical standards. All animal facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International).
Animal facilities in Shanghai and Suzhou have acquired PHS Animal Welfare Assurance. Our animal facility in New Jersey has acquired OLAW assurance. These accreditations and assurances reflect our commitment to providing the highest level of animal care and ensuring that all animal studies are conducted with the utmost regard for the animals' well-being.
Specialized Dosing, Sampling, and Study Execution
At WuXi Biology and Testing, we have highly specialized animal study teams dedicated to ensuring the successful implementation of experiments through close communication with our clients. Our teams include preclinical formulation experts, toxicologists, pharmacologists, pathologists, veterinarians, animal care specialists, and regulatory affairs experts.
Capabilities include conventional and specialized administration routes, repeated or continuous dosing, collection of diverse biological matrices, and surgical sampling approaches when required by the study objective. More than one-third of animal laboratory researchers hold AALAS certifications.
Large Animal PK Services
Our large animal PK platform supports flexible study designs across multiple non-rodent species, dosing routes, sample types, and development stages. Study teams can align species, dosing regimen, sampling strategy, and analytical support with the pharmacology, toxicology, formulation, and translational needs of the program.
- 4,000 large-animal capacity for Pharmacokinetic (PK studies) – including canine, Non-Human Primate (NHP), swine, rabbit and ferret
- Stock colony to minimize study lead times
- Integrated individual-animal file tracking system
- 10,000 m² / 108,000 ft² AAALAC (The Association for Assessment and Accreditation of Laboratory Animal Care International)-accredited vivarium
- NHP breeding facility with abundant supply
- Husbandry practices aligned with U.S. and EU standards
- OLAW (Office of Laboratory Animal Welfare) assurance approved
- Study capacity of >350 arms per week
- Dedicated surgery rooms and veterinary surgeons with 10+ years of experience
- On-site clinical chemistry and pathology
Turnaround Times
Established study workflows and animal availability can support efficient project initiation and reporting. Typical timelines depend on study design, washout requirements, bioanalysis, and any specialized procedures.
- Average 7 business days turnaround time from test-article receipt to report delivery for parallel designs
- 14 days for crossover designs (depending on washout time)
- Minimal lead time for small- and large-molecule PK in canines and NHPs
Dosing Routes
Dosing routes can be selected to reflect the intended clinical route, formulation strategy, exposure objective, or specific mechanistic question. Standard and specialized administration approaches are available depending on species and study requirements.
- Intravenous (bolus and infusion)
- Oral (solution, suspension, capsule, and tablet)
- Intramuscular
- Subcutaneous
- Intraperitoneal
- Transdermal
- Intranasal
- Intra portal vein
- Intraduodenal
- Rectal and vaginal
- Intraosseous
- Sublingual, buccal and gingiva
- Ocular drop
- Intracameral
- Intravitreal
- Intrathecal
- Parotid duct
Biological Matrices
PK and bioanalytical studies can incorporate plasma or blood sampling as well as specialized matrices and tissue samples to address distribution, excretion, local exposure, or route-specific questions.
- Blood, plasma, serum, bile, urine and feces
- Cerebrospinal fluid (CSF)
- Tears, aqueous humor, and vitreous humor
- Bone marrow
- Lymph fluid
- Liver biopsies
- Kidney biopsies
- Skin and muscle biopsies
- Bronchoalveolar lavage fluid (BALF)
Frequently Asked Questions
Large animal PK studies characterize the concentration-time profile and disposition of a drug or test article in non-rodent species such as dogs, non-human primates, swine, or rabbits. Depending on the study design, they can assess exposure, bioavailability, dose proportionality, tissue distribution, excretion, and other PK properties after single or repeated administration.
Large animal PK data can complement rodent and in vitro ADME results when a non-rodent species is scientifically relevant to the program. The data may help refine dosing regimens, compare formulations or routes, characterize exposure at pharmacology or toxicology doses, support PK/PD interpretation, and inform later preclinical development.
Species selection should be based on the scientific needs of the program. Considerations may include comparative metabolism and PK, target pharmacology, therapeutic modality, route and formulation feasibility, bioanalytical requirements, pharmacodynamic model relevance, and alignment with species planned for toxicology or other development studies.
The timing depends on the program. Large animal PK may be introduced during lead optimization or candidate selection to answer species-, formulation-, route-, or exposure-related questions, and it may also be used later to support toxicology planning, formulation bridging, or other preclinical development activities. Not every program requires the same sequence of species or studies.
Study designs may include single- or multiple-dose PK, parallel or crossover studies, intravenous and extravascular dosing, absolute or relative bioavailability, dose proportionality, formulation or salt-form comparisons, tissue distribution, and excretion studies. Specialized sampling, surgical procedures, and integrated bioanalysis can be incorporated when needed.
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