Large Animal (Non-Rodent) PK Study

Large Animal PK Study focused on PK research in non-rodent animals. From standard screening to IND (Investigational New Drug) studies, perform nearly all routes of administration with either single treatments in multiple animals, multiple compounds in a single animal, or a combination of treatments in a crossover study design. Our access to numerous tools and assets allows us to deliver better data, faster.

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Overview
Assays
Animal Species
Routes of Administration
Surgical Models
Experience
Facilities
FAQs
Related Resources
Related Services

In Vivo PK

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Overview

Since 2007, WuXi AppTec DMPK has been providing exceptional large animal testing services for drug metabolism to global drug development institutions. With different kinds of species including monkeys, dogs, pigs, rabbits, and ferrets, we are ready to meet diverse experimental needs. Our digital and intelligent work mode, combined with advanced equipment and smart data management, ensures real-time monitoring, accuracy, and reliability of data. Our experienced scientists provide insightful analysis and effective solutions. We always prioritize customer satisfaction, rigorous scientific approach, and precise operations. Through our innovative services, we aim to enhance drug development efficiency and speed up the market launch. Let’s collaborate to advance drug development and contribute to human health.

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Assays

Hit to lead
- Fast PK:
  Large animal PK (oral or intravenous administration)，single or cassette administration
Lead optimization
- - PK study in large animals (administered through oral, intravenous, short term infusion or 72-hour ambulatory infusion pump, subcutaneous, intramuscular, and Intrathecal routes.
  - Single or multiple doses
  - Exposure studies with different formulation
Preclinical candidate (PCC)
- - Single-dose or multiple-dose study following specific administration route
  - PK studies with different salt forms or crystal forms
  - PK studies with different dosage forms (Tablet, capsule, SDD, Nano-suspension, SEDDS), including bridging studies with clinical formulations
  - Food effect studies (high-fat food, maintenance food)
  - PK studies with adjustment the gastric pH (pentagastrin, famotidine)
  - Maximum tolerated dose experiment (MTD) and dose escalation experiment
Investigational New Drug (IND) application
- - PK studies of single-dose and single intravenous administration
  - Oral administration PK studies with high, medium, and low doses
  - PK studies of medium dose and multiple oral administration
  - Tissue distribution studies after a single oral administration
  - Biliary excretion studies with medium dose and single oral administration
  - Urine and fecal excretion studies with medium dose and oral administration
  - Identify major metabolites in plasma and excretion

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Animal Species

Dog
- Beagle Dog
Monkey
- Cynomolgus
- Rhesus Macaques
- Marmosets
Minipig
- Bama Mini-pig
Rabbit
- New Zealand White Rabbit
- Chinchilla Rabbit
- Dutch Rabbit
- Japanese White Rabbit
Ferret
- Sable Ferret

Routes of Administration

Drug administration is a vital component of in vivo PK studies. Proper administration route selection is of great significance during early drug screening and late drug development. A variety of administration routes have been developed according to client demand and forward-looking marketplace strategies to provide high-quality in vivo PK Study service for thousands of clients worldwide. Specialized and high-quality skills and techniques include, but are not limited to, single-dose administration, multiple-dose administration over consecutive days, continuous intravenous infusion for 72 hours without anesthesia, ocular administration, transdermal administration, intrathecal injection, etc. We constantly strive to provide better service and continuous improvement.

- CNS
  Intra-cerebroventricular dosing
  Intrathecal dosing
- Percutaneous drug delivery
  Intradermal injection
  Skin (Ointment, Patch, Gel, Films, Spray)
- Infusion
  Long-term intravenous injection
  Hepatic portal vein injection
  Intravenous bolus
- Ophthalmic drug delivery
  Intravitreous injection
  Intracameral injection
  Eyedrop dosing
- Oral cavity
  Sublingual dosing
  Buccal patch
  Sublingual patch
  Orally disintegrating tablet
- Enteral administration
  Duodenal dosing
  Jejunal dosing
  Ileal dosing
  Cecal dosing
  Colonic dosing
  Rectal dosing
- System or site
  Dose route
- Intranasal (spray, drip)
- Intra-articular injection
- Intraperitoneal injection
- Intravaginal dosing
- Intraosseous dosing
- Bladder dosing
Large Animal (Non-Rodent) PK Study Part Ⅰ Route of Administration

Surgical Models

Case Sharing of Surgical Model

Large animal PK surgical models are important tools for pharmacokinetic research of drugs. Through setting up surgery models, complex drug administration or sample collection can be carried out, helping researchers to have a deeper understanding of the absorption, distribution, metabolism, and excretion of drugs in the body. WuXi AppTec DMPK has professional surgical veterinarians with decades of experience in the development and operation of large animal surgical models, and can provide precise and reliable surgical model services, providing strong support for drug research and development.

Surgical Models
Case Sharing of Surgical Model

- Vascular cannula
  - Femoral vein cannulated
  - Hepatic portal vein cannula
  - A peripherally inserted central catheter (PICC)
- Non-vascular cannula
  - Bile duct cannula
  - Intestinal cannula
  - Mesenteric lymph duct cannula
  - Cervical lymphatics cannula
  - Thoracic duct cannula
  - Cisterna magna cannula
- Special operations
  - Whole-body tissue perfusion
  - Nasal mucosal lavage
  - Bronchoalveolar lavage
  - Intraarticular puncture
  - Bone marrow aspiration
  - CSF puncture
- Biopsy
  - Liver Biopsy
  - Skin Biopsy
  - Muscle Biopsy
  - Kidney Biopsy
Large Animal (Non-Rodent) PK Study Part Ⅱ Surgical Models
For drugs acting directly on the central nervous system, accurate detection of drug concentration in the brain contributes to evaluate the ability of drugs towards the target site. Moreover, the direct measurement of drug concentration of Cerebrospinal Fluid (CSF) has more accuracy than using the concentration of free drug in plasma to predict the drug concentration in the brain ^{1, 2}. The drug concentration of CSF can be used as an effective indicator for evaluating drug exposure for those CNS (Central Nervous System) drugs and provide a basis for these drug candidates to move to the next stage. We have established Cisterna Magna cannulation (CMC) models in monkeys and canines according to the literature ³ since 2009, which allows us to collect CSF samples consecutively without anesthesia to obtain relevant PK curves and evaluate the drug's ability to cross the BBB (blood-brain barrier). The longest patency of catheter in CMC model animal was up to 2 years, and we have standby CMC model animals for use anytime to shorten the leading time. Nearly 500 projects, including IND applications, were completed by 2023.
Objective: To compare the stability of the CMC model in dogs with different surgery recovery times.
METHODS: Lidocaine hydrochloride injection drug (25 mg/dog) was administered intravenously in 3 male beagle dogs five days, 14 days, 35 days, and 63 days after surgery. The plasma and CSF samples were collected at the same time point, and the results of drug concentration were as follows:
Conclusion: The data showed a slight deviation in drug concentration between the plasma and CSF matrix on postoperative days 5, 14, 35, and 63, indicating that our animal surgical model is reliable with consistent data.

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List of biological sample collection of large animals

Whole blood
Plasma
Serum
White blood cell
Erythrocytes
PBMC
Stratum corneum
Epidermis
Dermis
Subcutaneous tissue
Ocular tissues*
Brain tissue**
Bone marrow
Organs
Intestinal fluid
Gastric fluid
Joint fluid
Rectal mucosa
Oral mucosa
Nasal mucosa
Cerebrospinal fluid
Cerebrospinal fluid (multiple consecutive)
Lymph (surgical)
Bile (surgical)
Urine (metabolic cage)
Urine (puncture)
Urine (Cannula)
Feces (metabolic cage)
Biopsy of skin, muscle, liver tissue

The samples of ocular tissues include but are not limited to conjunctiva, cornea, iris, lens, ciliary body, retina, choroid, sclera, optic nerve, aqueous humor, vitreous body, and tear.

Samples of various brain tissues include but are not limited to the caudate nucleus, cerebellum, cerebral cortex, white matter of the cerebrum, cingulate gyrus, cingulate sulcus, corpus callosum, external capsule, internal capsule, globus pallidus, hippocampus, hypothalamus, pituitary gland, midbrain, medulla oblongata, optic nerve, optic chiasm, pons, shell, and spinal cord.

Large Animal (Non-Rodent) PK Study Part Ⅲ List of Organ and Tissue Collection

Experience

17+

Years of experience
100+/Year

Lager animal IND
20000+m²

Large animal facility
3,000+

Colony animals

Facilities

In-house AAALAC accredited animal facilities to house monkey, Dog, Mini-pig, Rabbit, Ferret

AAALAC Certificate
Surgery Room
Fruit Storage Room
Corridor
Cage Washer Room
Necropsy Room
Feed Storage Room
EU Dog Exercise Area
Mini-pig Exercise Area
EU Monkey Cage

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Including mouse，rat，hamster，monkey，dog，pig，rabbit，etc

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FAQs

What is a Large Animal PK study?

A Large Animal PK (Pharmacokinetic) study refers to the study of how a drug is absorbed, distributed, metabolized, and excreted in large animals (non-rodent animals).
Why are large animals (non-rodent animals) used for pharmacokinetic research?

This type of study is often a critical part of preclinical drug development and is used to understand how a drug behaves in a biological system that is more similar to humans than smaller animals (rodent animals), like mice or rats.

Related Resources

Browse All Large Animal (Non-Rodent) PK Study Resources

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References

1.
Maurer TS, DeBartolo DB, Tess DA, Scott DO (2005) Relationship between exposure and non-specific thirty-binding of three central nervous system drugs in mice. Drug Metab Dispos 33:175-181
2.
Liu X, et al. (2009) Unbound drug concentration in brain homogenate and cerebral spinal fluid at steady state as a surrogate for unbound concentration in brain interstitial fluid. Drug Metab Dispos 37:787-793
3.
Gilberto DB, Zeoli AH, Szczerba PJ, Gehret JR, Holahan MA, Sitko GR, Johnson CA, Cook JJ, Motzel SL. Contemp Top Lab Anim Sci. 2003 Jul; 42 (4): 53-9

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Large Animal (Non-Rodent) PK Study

Overview

Assays

Hit to lead

Lead optimization

Preclinical candidate (PCC)

Investigational New Drug (IND) application

Animal Species

Dog

Monkey

Minipig

Rabbit

Ferret

Routes of Administration

Surgical Models

Case Sharing of Surgical Model

List of biological sample collection of large animals

Experience

Facilities

Learn more about our facilities

FAQs

What is a Large Animal PK study?

Why are large animals (non-rodent animals) used for pharmacokinetic research?

Related Resources

Application and Best Practices of Liver Biopsy in Non-Rodents

Breaking Barriers in CNS Drug Development with Intrathecal Administration

In Vivo PK | What Are We Striving For?

Evaluation of Different Tissue Processing Methods in Bama Pig Skin as an Animal Model for Topical Delivery Systems

Development and Implementation of an Animal Whole Life Cycle Management System

Application of Innovative Intelligent Electronic Cage Cards in Large-Scale Animal Facilities