In Vivo Pharmacokinetics
Generate meaningful PK insights before your proof of concept (POC) pharmacology studies—optimize dose selection, formulation strategies, and understand tissue specific exposure.
Why In Vivo PK is Critical to Your Program
In vivo pharmacokinetic (PK) studies reveal how a drug is absorbed, distributed, metabolized, and excreted (ADME) in animal models. These data form the foundation for dose selection, formulation decisions, toxicology study design, and translation to first-in-human studies.
Unlike in vitro experiments, in vivo PK provides a whole picture assessment and the context needed to understand exposure, clearance, and potential dose-limiting factors before conducting your pharmacology POC. This nonclinical PK extends to the selection of doses for toxicology testing and also understanding potential human exposure before entering the clinical testing stage of development.
Xyzagen’s In Vivo PK Solutions
At Xyzagen, we focus on more than generating numbers, which is why we talk about our First-in-Rodent design philosophy. Our scientists not only interpret in vivo PK results in the context of your program but can talk to you about incorporating other endpoints for a more robust evaluation of exposure and tolerability, similar to a Phase 1 First-in-Human clinical trial. We also understand the importance of cost, and that sometimes a simple exposure study is all that’s needed.
In Vivo PK Capabilities
Xyzagen provides a full suite of nonclinical in vivo pharmacokinetics services to support early discovery through IND-enabling development.
NonGLP Nonclinical Pharmacokinetics
Our NonGLP PK services combine discovery-focused study design, in vivo expertise, and integrated bioanalysis to generate data that drives smarter decisions. Explore our NonGLP Nonclinical Pharmacokinetics capabilities:
Early Discovery PK
First-in-Rodent Capabilities
Proprietary First-in-Mouse® and First-in-Rat® design philosophy approaches maximize insight from early PK studies, enabling faster, more informed go/no-go decisions.
Mechanistic Insight
In Vivo Drug Metabolism & (Ocular) Tissue Distribution Studies
Evaluate metabolic stability, metabolite profiles, and pathways that impact safety and efficacy.
Regulatory-Enabling PK
Single-Dose & Repeat-Dose PK Studies
Characterize systemic exposure, accumulation, and clearance across dose levels using your toxicology formulation to support safety, efficacy, and translational modeling.
GLP Toxicokinetics
Design and analyze nonclinical studies to characterize drug exposure and support clinical dosing strategies within your GLP toxicology studies.
Why Choose Xyzagen?
With decades of experience in regulatory interactions, IND submissions, Advisory Committees, and NDA approvals, our senior scientists are regulatory experts and bring both a technical depth and practical perspective. We act as an extension of your team, anticipating challenges, not forgetting the science in order to create clear regulatory narratives that coordinate efficiently across disciplines.
Our team has extensive experience supporting submissions and interactions with global regulatory authorities, including the FDA, EMA, Health Canada, MHRA, and the Australian TGA—helping ensure your program meets international standards and advances smoothly toward approval.
Contact Us
Ready to get more from your in vivo PK program? Contact Xyzagen to learn how our integrated expertise and proprietary approaches can accelerate your path from discovery to clinic.
