Driving Better Decisions with In Vivo PK Studies
In Vivo Pharmacokinetics (PK) Studies
In vivo pharmacokinetic (PK) studies provide quantitative insight into how a drug is absorbed, distributed, metabolized, and eliminated in biological systems. These studies generate critical exposure data that guide candidate selection, dose optimization, formulation development, and regulatory decision-making throughout preclinical drug development.
Our integrated workflow combines study design, bioanalysis, pharmacokinetic interpretation, and seamless integration with discovery biology, in vivo pharmacology, toxicology, and PK/PD modeling to support informed decision-making throughout preclinical drug development. By connecting drug exposure with pharmacological activity and safety evaluation, researchers can make more confident decisions from lead optimization through IND-enabling studies.
In Vitro ADME Studies Annually
In Vivo Studies Annually
Successful IND Filings
Designing the Right In Vivo PK Strategy
Different stages of drug development require different pharmacokinetic study designs. Early discovery programs often prioritize rapid screening to compare candidate molecules, whereas later-stage studies focus on generating robust pharmacokinetic data to support regulatory submissions. Selecting the appropriate study design helps researchers efficiently characterize drug exposure while generating data that supports candidate selection and clinical translation.
Exposure Characterization
Evaluate systemic drug exposure following single-dose or multiple-dose administration to understand pharmacokinetic behavior, accumulation, and dose proportionality.
Bioavailability Assessment
Compare intravenous and extravascular administration routes to determine absolute or relative bioavailability and assess formulation performance.
Distribution Studies
Characterize drug distribution into plasma, blood, cerebrospinal fluid (CSF), and target tissues to understand exposure at sites of action.
Sample Collection
Collect plasma, blood, urine, feces, bile, CSF, or tissue samples to support comprehensive pharmacokinetic analysis and metabolite profiling when appropriate.
Turning PK Data into Development Decisions
PK studies generate quantitative parameters — including Cmax, Tmax, AUC, clearance, half-life, volume of distribution, bioavailability, and mean residence time — that describe a drug candidate's disposition in vivo. Together, these data support candidate selection, formulation optimization, dose selection, exposure-response analysis, and translation into PK/PD modeling and clinical development. They also provide essential evidence for interpreting efficacy and toxicology studies and help establish dosing strategies for subsequent preclinical and clinical studies.
Integrated PK Solutions
In vivo PK studies provide the greatest value when integrated with discovery biology, bioanalysis, pharmacology, toxicology, and PK/PD modeling. Our multidisciplinary platform supports seamless study design, quantitative bioanalysis, pharmacokinetic interpretation, biomarker evaluation, and translational decision-making throughout the drug development journey.
By integrating exposure data with pharmacodynamic biomarkers, efficacy endpoints, and safety findings, researchers gain a more comprehensive understanding of exposure-response relationships and therapeutic windows, helping reduce development risk before clinical studies.
Species-Specific PK Studies
Depending on the stage of development, therapeutic modality, and regulatory requirements, PK studies may be conducted in both rodent and non-rodent species. Rodent PK studies are commonly used for hit-to-lead optimization, candidate selection, and pharmacology studies, while non-rodent PK studies often support IND-enabling programs, toxicology studies, and regulatory submissions.
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Frequently Asked Questions
In vivo pharmacokinetic (PK) studies evaluate how a drug is absorbed, distributed, metabolized, and eliminated within a living organism. These studies generate critical information on systemic exposure, bioavailability, clearance, half-life, and tissue distribution, helping researchers understand whether sufficient drug reaches the intended site of action. The resulting PK data support candidate selection, dose optimization, formulation development, efficacy interpretation, and progression into IND-enabling studies.
Common pharmacokinetic parameters include maximum plasma concentration (Cmax), time to maximum concentration (Tmax), area under the concentration-time curve (AUC), clearance (CL), volume of distribution (Vd), elimination half-life (t½), bioavailability (F), and mean residence time (MRT). Together, these measurements characterize a drug's disposition in vivo and provide quantitative information for comparing formulations, administration routes, and dosing regimens. They also support PK/PD modeling and dose selection for future studies.
Species selection depends on the therapeutic modality, pharmacology, intended clinical indication, and regulatory expectations. Rodent species, such as mice and rats, are commonly used during early drug discovery for candidate selection and pharmacology studies, whereas non-rodent species — including dogs, non-human primates, minipigs, or rabbits — may be required for IND-enabling studies. The most appropriate model is selected based on the scientific objectives of each program.
PK studies generate quantitative exposure data that are essential for interpreting efficacy and toxicology findings, selecting dose levels, and establishing exposure margins. These data support first-in-human dose selection, study design, and regulatory documentation required for IND submissions. Together with bioanalysis, toxicokinetic, and pharmacology data, PK studies provide an important foundation for regulatory decision-making.
PK studies focus on how the body affects a drug by measuring absorption, distribution, metabolism, and excretion over time. PK/PD studies extend this analysis by integrating pharmacokinetic data with pharmacodynamic biomarkers or efficacy endpoints to evaluate the relationship between drug exposure and biological response. Combining PK and PD information helps optimize dosing strategies and better predict therapeutic outcomes.
Rodent PK studies are commonly used during hit-to-lead optimization, lead optimization, and early pharmacology studies because they provide rapid and cost-effective evaluation of drug exposure. Non-rodent PK studies are typically performed later in development to support toxicology studies, regulatory requirements, and IND submissions. The appropriate species depends on the therapeutic modality, pharmacological relevance, metabolism, and regulatory expectations for each development program.
In vitro ADME studies provide early insight into absorption, metabolism, transporter interactions, and other developability characteristics, while in vivo PK studies confirm how these properties translate into systemic drug exposure in a living organism. Together, these complementary approaches improve candidate selection, support IVIVE and PK/PD modeling, and reduce uncertainty before advancing compounds into IND-enabling development. Integrating both datasets enables more informed decision-making throughout drug discovery.
Yes. In vivo PK studies are frequently integrated with efficacy, pharmacodynamic (PD), biomarker, and disease model studies to better understand the relationship between drug exposure and therapeutic response. Combining these endpoints within a single study can improve translational relevance, reduce animal use, and generate more comprehensive datasets for decision-making. This integrated approach is particularly valuable during lead optimization and preclinical development.