Large Animal Pharmacokinetics
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Expert PK Studies to Advance Your Compound
In vivo Pharmacokinetics (PK) studies the absorption, distribution, metabolism, and excretion (ADME) processes of specific xenobiotics/chemicals, or their metabolites after administration, to understand how the body interacts with them. In vivo PK studies play an essential role in new drug discovery and development stages, as these studies can help drug developers to optimize the dosing regimen, understand potential toxicity, and determine the appropriate drug formulation for human use.
WuXi AppTec is a full-service preclinical testing partner that acts as an extension of your team, leveraging a complete package of services to support the development of your compound. We offer a wide range of PK studies for large animals, including canines, non-human primates (NHPs), swine, and rabbits. From bioanalysis to metabolite profiling and identification and tissue distribution to comprehensive toxicological safety assessments services, our experts are with you through every step. We’ll collaborate with you to design studies, analyze the data, and provide the insights to advance your compound to the next milestone.
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.
Dedicated Animal Study Teams
At WuXi AppTec, 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. More than one-third of our animal laboratory researchers hold AALAS (American Association for Laboratory Animal Science) certifications.
Large Animal PK Services
WuXi AppTec offers a full range of PK services for large animal studies in tandem with our small animal PK studies. From aggressive turnaround times to a broad array of dosing routes, we can help you design a study ideally suited to your timeline and compound. We help you to minimize the risk of adverse events and maximize the likelihood of a successful drug development 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 following U.S. and EU standards
- OLAW (Office of Laboratory Animal Welfare) assurance approved
- Capacity: >350 arms per week
- Human-class surgery room, dedicated veterinary surgeons with 10+ years of experience
- On-site clinical chemistry and pathology
Turnaround Times
Take advantage of industry leading turnaround times that keep your project on schedule without unnecessary delays.
- 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
We offer a broad selection of dosing routes to test for, based on the specifics of your compound and development strategy.
- Intravenous (bolus and infusion)
- Oral (solution, suspension, capsule, and tablet)
- Intramuscular
- Subcutaneous
- Intraperitoneal
- Transdermal
- Intranasal
- Intra portal vein
- Intraduodenal
- Rectal/Vaginal
- Intraosseous
- Sublingual, Buccal and gingiva
- Ocular drop
- Intracameral
- Intravitreal
- Intrathecal injection
- Parotid duct
Biological Matrices
Our testing services support quantitative evaluation of an analyte within a variety of biological matrices.
- Blood, plasma, serum, bile, urine and feces
- Cerebrospinal fluid (CSF)
- Tears, aqueous humor, vitreous humor
- Marrow
- Lymph fluid
- Liver biopsies
- Kidney biopsies
- Skin and muscle biopsies
- BALF (Bronchoalveolar Lavage Fluid)
Large Animal PK FAQs
What are large animal pharmacokinetic studies?
Large animal PK studies are a type of preclinical research that evaluates how a drug or testing article behaves after administration in the body of a large animal, such as dogs, pigs, or non-human primates. The results from these studies are used to determine the absorption, distribution, metabolism, and excretion (ADME) processes of a drug or testing article to gain a better understanding of pharmacokinetic behavior within the animal body.
How do large animal PK studies add value to my testing program?
Large animal PK studies help to optimize the dosing regimen, identify potential toxicity, and provide the appropriate drug formulation for human clinical trials. These large animals have physiological and metabolic characteristics that closely resemble those of humans.
What role does vivo large animal PK play in a larger PK testing program?
Large animal PK studies fill in the gaps between preclinical PK testing in small animals like rodents and clinical PK testing in humans. Large animals have physiological and metabolic characteristics more similar to humans than small animals. As a result, the data obtained from these studies can help to predict how a drug will behave in humans.
When do I need to do large animal PK testing?
You typically need to conduct large animal PK studies after you have completed in vitro testing and small animal PK testing, and before you begin clinical trials in humans.
What should I do if I have more questions or want to get started?
Learn more about WuXi AppTec’s DMPK services or TALK TO AN EXPERT today.
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Whether you need a testing program tailored to your product or have questions about a large animal PK strategy, we can help.