Rodent Pharmacokinetics
Rodent pharmacokinetic (PK) studies evaluate in vivo ADME and are crucial for determining appropriate drug exposure, dose requirements, and other PK parameters to facilitate efficacious and safe studies. Our experts can design a customized Rodent PK program that delivers the correct data for successful IND and NDA submissions.
Small Animal PK Studies
Environmentally-Controlled Animal Rooms
Square FT of Lab Testing Space
Comprehensive Rodent PK Testing
WuXi AppTec is a global leader in preclinical testing, offering AAALAC-accredited facilities and expert teams skilled in various dosing, tissue collection, and surgical techniques to meet complex study needs. Our customized in vivo PK programs support every stage of drug development, from discovery to IND-enabling studies. Watch our video to see how we uphold the highest standards of animal care and ethical research.
- Experienced team, including veterinarians & PhDs
- AAALAC-accredited facilities
- Numerous dose routes
- Diverse biological matrices/tissue collection & surgical techniques
- Accommodate a wide range of study requirements
Hit to Lead Assays
Understand ADME, CNS penetration, Intestinal permeability, and how the drug behaves in disease models.
- Fast PK: Rodent PK (oral or intravenous administration)
- Targeted PK experiment: For example, study on the central nervous system and brain/plasma ratio determination
- Routine PK experiments: Study-specific disease model based on PK results and exposure-based Proof of Concept (POC) model testing
Lead Optimization Assays
Assess optimization strategies for dosing, formulations, and tissue distribution.
- PK studies for rats and mice, including single or multiple doses
- Exposure studies with different formulations
- Collection of different biological samples, such as cerebrospinal fluid, bile, urine, and feces
- Tissue distribution validation studies; specific tissues can be collected such as brain, heart, liver, and lung
Preclinical Candidate (PCC) Assays
Evaluate PK, PD, toxicity, efficacy, and safety profiles to determine clinical viability.
- Single-dose or multiple-dose experiment following specific administration route
- PK experiments with different salt or crystal forms
- PK experiments with different dosage forms, including bridging studies with clinical formulations
- Tissue distribution study: Multiple tissues can be collected, such as the heart, liver, spleen, lung, kidney, small intestine, large intestine, muscle, and fat
- Excretion study: Biological samples collection such as bile, feces, and urine
- Maximum tolerated dose experiment (MTD) and dose escalation experiment
Investigational New Drug (IND) Application
Generate the critical safety and feasibility data required for IND submission.
- 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
Rodent Species We Have Available
The rodents used in our PK studies are selected due to their physiological similarities to humans, widespread availability, and the presence of well-established handling and dosing techniques.
Mouse
- CD-1
- C57BL/6
- BALB/c
- FVB
- DBA/1
- DBA/2
- SJL
- 129
- BALB/c Nude
- NU/NU Nude
- CD-1 Nude
- CB-17 SCID
- SCID Beige
- NOD SCID
- OB Mouse
- DB Mouse
- P-gp/BCRP KO Mouse
Rat
- Sprague Dawley
- Wistar Han
- Wistar
- Brown Norway
- F344(CDF)
- Lewis
- Hamster (LVG Golden Syrian Hamster)
- Guinea pig (Harley Guinea Pig)
A Global Partner for Preclinical ADME
When it comes to rodent pharmacokinetics, WuXi AppTec’s highly trained DMPK team stands ready to offer expert support from discovery to IND to NDA. Explore our comprehensive services, including targeted rodent PK studies, and learn how we can help advance your development journey.
Surgical Models for Rodent PK
Our rodent animal surgical models include vascular and non-vascular cannulation for blood or fluid sampling, and non-survival surgeries for various in situ PK studies and technique validation.
Vascular Cannulation
Allows for controlled, precise access to blood vessels to ensure accurate and consistent sampling.
Non-Vascular Cannulation
Allows for cannulation via non-vascular methods, including for drugs with non-blood-based distribution or metabolism.
Non-Survival Surgery
Procedures are conducted ethically and in accordance with the highest standards of care.
Frequently Asked Questions
What are rodent pharmacokinetics (PK) studies?
Rodent pharmacokinetic (PK) studies evaluate in vivo the time course of the test article being absorbed, distributed, metabolized, and excreted in rodents, typically mice or rats.
How do rodent PK studies add value to a testing program?
Rodent PK studies are an integral component of drug development in preclinical research. These studies yield crucial insights into appropriate drug exposure, dose requirements, and other pharmacokinetic (PK) parameters, facilitating efficacious and safe studies.
When do you need rodent PK studies?
Rodent PK assays are employed throughout different stages of drug development to assess drug ADME properties, guide lead optimization, aid in formulation development, support preclinical safety and efficacy studies, and fulfill regulatory requirements. These assays contribute to a thorough understanding of a drug candidate’s pharmacokinetics, helping to make informed decisions and optimize the chances of successful regulatory submission.
What animal models do you use in rodent PK studies?
We utilize a variety of rodent models, including rodents such as mice and rats, depending on the study requirements and the nature of the compound being tested. Our choice of models is guided by regulatory standards and the specific needs of each study.
What is the turnaround time for a rodent PK study?
The turnaround time is approximately 5 business days for a one-day, routine rodent pharmacokinetic study, from receiving the test article to delivering a PK report.
What is the difference between mouse and rat PK studies?
Mice and rats differ in size and drug disposition, which can impact PK profiles, such as drug distribution, clearance rates, and metabolic pathways. These species-specific differences should be considered when interpreting PK data and extrapolating findings. Researchers must select the appropriate species based on their specific research objectives to ensure accurate and relevant preclinical data for drug development.
How do you perform a rodent PK study?
Conducting rodent PK studies can vary depending on the drug, study objectives, regulatory guidelines, and available resources. During the discovery, preclinical optimization and IND (Investigational New Drug) stages, rodent PK studies are usually performed in a non-GLP environment. However, it is essential to note that regulatory requirements can vary depending on the specific circumstances and jurisdiction.
What roles do surgery models and techniques play in rodent PK?
Surgery models and techniques play a crucial role in rodent pharmacokinetic studies for drug development, allowing for precise administration of drugs and collection of biological samples, and enabling the evaluation of pharmacokinetic parameters and drug behavior in a controlled environment.
How do different rodent PK surgical techniques affect drug development?
Surgical techniques can aid in studying drug absorption, distribution, metabolism, and excretion, providing valuable insights into drug performance and guiding formulation optimization. Moreover, surgery models can help assess tissue-specific drug concentrations, explore target organ interactions, and investigate the impact of surgical interventions on drug pharmacokinetics, ultimately contributing to the refinement and advancement of drug development strategies.