Pharmacokinetics Services
High-Quality Translational PK Data to De-Risk Candidates and Support IND-Enabling Development
Our integrated Pharmacokinetics (PK) platform generates high-quality in vivo PK, tissue distribution, and PK/PD across discovery and preclinical development. Supported by AAALAC- and OLAW-accredited facilities, advanced surgical capabilities, and integrated bioanalysis, formulation, and ADME expertise, we help sponsors characterize exposure, refine dosing strategies, and strengthen development decisions.
Why Pharmacokinetics Matters in Drug Development
Potency alone is not sufficient. Successful candidates must demonstrate adequate exposure, appropriate distribution, and well-characterized clearance in relevant models to support translational decision-making.
Our PK studies help answer critical development questions:
- Is systemic and target-tissue exposure sufficient to support pharmacological activity?
- How do formulation and route of administration affect exposure and bioavailability?
- What exposure-response relationships emerge in PK/PD analyses?
- Are there species differences or clearance liabilities that could affect translational relevance?
- How can dose levels and dosing schedules be refined for preclinical and IND-enabling studies?
Comprehensive In Vivo PK Studies
Multi-Species Expertise Supporting Diverse Drug Modalities
Our pharmacokinetics platform supports exploratory through IND-enabling PK studies across a broad range of species, dosing routes, and sampling strategies.
- Species: Mouse, Rat, Guinea pig, canine, NHP, Mini-pig
- Study Types: Single-dose PK, multiple-dose PK, cassette PK, tissue distribution, excretion and mass balance studies, PK/PD studies, DDI studies, ocular PK studies, bioavailability assessment, and translational PK support
Integrated workflows support rapid discovery-stage decision-making as well as more advanced preclinical and IND-supporting development programs.
In vivo pharmacokinetics platform supporting multiple species and dosing strategies
Cassette PK (6 in 1) – High-throughput platform accelerating lead optimization and reducing cost
Dosing Routes and Advanced Surgical Models
Extensive Administration and Sampling Capabilities
Different therapeutic programs require tailored dosing and sampling strategies to evaluate exposure, absorption, tissue distribution, and excretion.
Dose routes include:
- Intravenous (IV)
- Oral (PO)
- Intraperitoneal (IP)
- Subcutaneous (SC)
- IV infusion
- Intrathecal
- Intracerebroventricular (ICV)
- Intratracheal
- Intranasal
- Buccal
- Capsule dosing in rats
- Osmotic minipump or programmable infusion pump administration
Surgical and specialized sampling models include:
- Portal vein cannulation
- Mesenteric lymph duct cannulation
- Bile duct cannulation
- Jugular cannulation
- Femoral cannulation
- Carotid cannulation
- Cerebrospinal fluid (CSF) collection
- Micro-sampling
- Liver biopsy
- Renal biopsy
These physiologically relevant models enable detailed characterization of absorption, lymphatic transport, CNS exposure, excretion pathways, and tissue distribution across small molecules and advanced therapeutic modalities.
Biliary and renal excretion pharmacokinetics study in NHP model
PK/PD Analysis and Translational Support
Turn PK Data into Development Insight
PK data become more informative when interpreted alongside pharmacodynamic readouts, biomarker data, and study design and endpoints. Our platform supports PK/PD studies and translational interpretation to help teams understand exposure-response relationships and make more informed dose and scheduling decisions.
Capabilities include:
- PK/PD data analysis
- Noncompartmental analysis (NCA)
- Exposure-response interpretation
- Translational PK assessment
- Dose projection and simulation support
- Cross-species comparison
- Integration with biomarker and bioanalytical data
- Support for regulatory submissions
By integrating PK data with bioanalysis, ADME, formulation, and toxicology datasets, we enable a more complete understanding of exposure–response relationships, supporting dose optimization, safety margin assessment, and translational decision-making..
Formulation Support for PK Studies
Our formulation team works closely with PK scientists to address solubility, stability, and exposure challenges that can confound in vivo interpretation. This integrated approach helps ensure PK results accurately reflect compound behavior under study-relevant dosing conditions.
Key capabilities include:
- Physicochemical profiling, including Log P/LogD, pKa, solubility, and stability
- Salt and polymorph screening
- Small-scale solid dispersion screening
- Spray-dried dispersion (SDD) preparation using BUCHI S-300
- Suspension, solution, and nano-suspension development
- Formulation selection based on route of administration, study objectives, and exposure requirements
Typical timelines include:
- Small-scale solid dispersion screening: approximately 2 weeks
- SDD preparation: approximately 1 week per batch
PK/PD Modeling, Simulation & Translational Support
Turn Data into Actionable Insights
- Non-compartmental analysis (NCA)
- Exposure-response modeling and interpretation
- PK/PD translational modeling and simulationHuman dose projection
- Cross-species comparison and support for regulatory filing
Integration with bioanalysis and metabolite identification supports high-confidence data packages and strengthens translational decision-making.
Integrated Bioanalysis
Seamless Support from Discovery to Regulated Studies
Our PK studies are closely integrated with discovery-stage and regulated bioanalysis, helping reduce handoff delays and improve continuity from sample collection through to reporting.
- Small Molecules: LC-MS/MS analysis of parent drug and metabolites in plasma, tissues, and other relevant matrices
- Large Molecules: ELISA, MSD, and mass spectrometry-based analysis PK/PD, biomarker, and immunogenicity analysis
- Regulated bioanalysis: Bioanalytical method development, qualification, validation, and biological sample analysis
This integrated approach supports consistent and high-quality data generation across exploratory, preclinical, and IND-enabling studies.
Research Infrastructure
Research Facilities Supporting PK Execution
Our PK studies are supported by AAALAC- and OLAW-accredited facilities designed to support both discovery-stage and regulated development programs.
Capabilities include:
- Dedicated small and large animal research centers
- Specialized surgical suites
- Micro-sampling support
- Integrated bioanalytical support
- Exploratory toxicology support
- PK and TK sample analysis
This infrastructure supports efficient study execution across diverse therapeutic modalities and study designs.
Integrated DMPK Support
Because pharmacokinetics studies are embedded within a broader DMPK and bioanalytical framework, study findings can be directly connected to adjacent services and key decision points across development.
This includes integration with:
- In vitro ADME
- Bioanalysis
- Metabolite identification
- Exploratory toxicology
- Formulation development
- IND-enabling support
This model helps preserve scientific continuity from early discovery through preclinical development and regulatory preparation.
Discuss Your Pharmacokinetics Strategy
Whether you are evaluating early PK characteristics, optimizing formulation strategy, or preparing for IND-enabling studies, our scientists can help design integrated PK programs aligned with your development goals.
FAQ Section:
Frequently Asked Questions About Pharmacokinetics Services
What are pharmacokinetics studies used for?
Pharmacokinetics studies evaluate how compounds are absorbed, distributed, metabolized, and eliminated to support dose selection and translational decision-making.
What species are commonly used in PK studies?
Common species include mouse, rat, rabbit, canine, NHP, guinea pig, and mini pig models.
What is the purpose of PK/PD modeling?
PK/PD modeling helps link exposure to pharmacological response to improve dose strategy and translational understanding.
Why is formulation important in PK studies?
Formulation can significantly affect solubility, absorption, bioavailability, and interpretation of exposure during drug development.
What surgical models are used in PK research?
Common models include bile duct cannulation, portal vein cannulation, lymph duct cannulation, and cerebrospinal fluid (CSF) collection techniques.
Can pharmacokinetics studies support biologics and complex modalities?
Yes. Modern PK platforms support biologics, peptides, oligonucleotides, ADCs, PROTACs, and related therapeutic modalities.
