Rodent Pharmacokinetics

Rodent pharmacokinetic (PK) studies evaluate in vivo the time course of the test article being absorbed, distributed, metabolized, and excreted. Rodent PK studies are crucial for determining appropriate drug exposure, dose requirements, and other PK parameters to facilitate efficacious and safe studies. Our experienced team can design an in vivo rodent PK program that’s tailored to your candidate, resulting in the right data for successful IND (Investigational New Drug) and NDA (New Drug Application) submissions.

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Expert Rodent PK Support to Advance Your Compound

When it comes to your rodent PK needs, WuXi AppTec’s highly trained DMPK team stands ready to offer expert support throughout the entire drug development process, from discovery to IND to NDA. We are fully committed to supporting you for any rodent PK studies and advancing your drug development towards success. By partnering with WuXi AppTec, you gain access to an exceptional team of professionals with a wealth of knowledge and experience.

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Comprehensive Rodent PK Study Capabilities

WuXi AppTec is a global expert in preclinical testing, with AAALAC-accredited facilities, experienced teams, and numerous dosing routes, biological matrices/tissue collection techniques, and surgical techniques to accommodate diverse study requirements. We have extensive experiences in rodent PK studies, including rat pharmacokinetic and mouse pharmacokinetic studies. We can work with you at any stage of drug development to develop a specific in vivo PK program tailored to your needs (Table 1), whether it is during the early discovery phase or preclinical stage, in preparation for IND submission.

Species for Rodent Pharmacokinetics

Rodents are selected for pharmacokinetic studies during drug discovery and development due to their physiological similarities to humans, widespread availability, and the presence of well-established handling and dosing techniques. At WuXi AppTec, we offer the following species for rodent PK studies:

Mouse Pharmacokinetics (MPK)

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 Pharmacokinetics (RPK)

Sprague Dawley
Wistar Han
Wistar
Brown Norway
F344(CDF)
Lewis

Other Rodent PK Species

Hamster (LVG Golden Syrian Hamster)
Guinea pig (Harley Guinea Pig)

Route of Administration for Rodent PK

Drug administration plays a crucial role in rodent PK studies, and selecting the appropriate route of administration is vital in both the early and late stages of drug development. At WuXi AppTec, we understand this importance, and we have developed over 30 different routes of administration based on customer needs. Our team has also achieved remarkable milestones in establishing unique technical capabilities. Below, you will find a table summarizing our team’s dosing technical competencies:

Rodent PK Surgical Models and Techniques

Surgery models and techniques play a crucial role in rodent pharmacokinetic studies for drug development. These models allow for precise administration of drugs and collection of biological samples, enabling the evaluation of pharmacokinetic parameters and drug behavior in a controlled environment.

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.

Rodent Pharmacokinetics Assays FAQs

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 my 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.

What is the difference between rat and mouse PK studies?

Mouse and rat differ in size, metabolic pathway, 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.

When do you need rodent PK assays?

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.

How do you perform a rodent PK study? Do I need to follow Good Laboratory Practice (GLP) guidelines?

The conduction of 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 under a non-GLP environment. However, it is important to note that regulatory requirements can vary depending on the specific circumstances and jurisdiction.

What is the turnaround time for rodent pharmacokinetics assays?

For a one-day acute rodent pharmacokinetic study, the turnaround time, from receiving the test article to delivering a PK report, is approximately five business days.