PBPK and QSP for Veterinary
Drug Development and
Animal Safety

Developing veterinary drugs requires navigating the diverse physiology of different animal species, where factors like breed, age, and health status impact drug responses.

Physiologically based pharmacokinetic (PBPK) modeling enhances drug development by simulating absorption, distribution, metabolism, and elimination (ADME) processes across species. This approach supports the design of safe, effective, and species-specific treatments. PBPK models help optimize dosing regimens, predict side effects, and assess exposure risks. For food-producing animals, they determine safe withdrawal times to ensure compliance with regulatory standards.

By integrating PBPK modeling into veterinary drug development, we help reduce reliance on animal testing, improve translational accuracy, and support ethical, data-driven decisions throughout the R&D and regulatory lifecycle. PBPK modeling contributes in many ways, including simulating “what-if” scenarios, enabling species extrapolation, predicting chemical concentrations in tissues, milk, or eggs, linking exposure to pharmacodynamic endpoints, streamlining development, informing dosing strategies and study design, and guiding formulation development.

Physiologically based biopharmaceutics modeling (PBBM) is a specific field of PBPK model applications that aims to establish the link between the formulation’s properties and in vivo performance.

This field of application of PBPK modeling is evolving at a fast-pace and offers the link between in vivo and in vitro to support pharmaceutical development in the selection of the best drug substance and product, as well as later in development in the establishment of manufacturing quality and controls.
Dissolution testing is often a key input in PBBM. Results from in vitro experiments characterizing drug substances and the formulation behavior (e.g., solubility, particle size, dissolution) can be linked to key ADME parameters and integrated into full PBPK models to predict PK exposure in plasma and/or specific tissues or organs.

These models can also be linked to Pharmacodynamic (PD) relationships to derive the impact of physicochemical, drug and formulation properties on safety and efficacy. The role of Physiologically Based Biopharmaceutics Modeling (PBBM) in drug development spans multiple stages, including supporting patient-centric design, guiding life cycle management, informing regulatory submissions, streamlining development processes, optimizing dosing strategies, enhancing study design, and aiding in formulation development and developability assessment.

What we can offer

ESQlabs offers a comprehensive suite of modeling and simulation services tailored to the unique requirements of veterinary drug development and animal safety. Our expertise in physiologically based pharmacokinetic (PBPK) modeling enables the design of predictive models that account for interspecies differences and the physiological variability within animal populations. We create customized models that simulate absorption, distribution, metabolism, and excretion (ADME) processes across a range 
of species, including livestock, companion animals, and wildlife. Our services support clients in optimizing dosing regimens for veterinary therapeutics, estimating safe withdrawal periods for food-producing animals, and predicting drug exposure across life stages, including pregnancy and lactation.

By incorporating animal-specific data and physiology, our models allow for precise and ethical drug development, reducing the need for extensive animal testing and enhancing the reliability of safety assessments. We also support regulatory submissions by generating transparent, data-driven justifications aligned with evolving international guidelines, helping clients address new expectations around model-informed approaches and reduce time to approval.

Animal-specific models can be applied across different disease areas and dosing strategies:

Routes of administration:

  • Oral
  • Dermal
  • IV
  • IM and SC

Disease areas:

  • Infectious diseases
  • Parasitic infections
  • Pain and inflammation
  • Reproductive health
  • Metabolic disorders

PBPK enables a holistic and knowledge-based, model-informed approach for veterinary and animal safety applications in the species:

  • Rodents (Mouse, Rat, Rabbit)
  • Monkey
  • Dog (Generic and Beagle)
  • Cat
  • Swine (Minipig, Landrace)
  • Birds (Chicken, Duck, Quail)

This approach is invaluable for designing veterinary drugs that are effective across different animal breeds, ages, and health statuses. Whether it’s determining the appropriate dosage for a specific species or assessing potential risks in mixed animal populations, our modeling tools provide actionable insights for safer and more effective veterinary treatments.

Related Platforms

Large Molecules, Biologics and Novel Modalities

Advancing PBPK-based solutions for (Bi-specific) antibodies, conjugated drugs, gene therapy, and other novel modalities.
Find out more 

Small Molecules and Chemicals

Advancing PBPK-based solutions for small molecules and chemicals across all services.
Find out more 

QSP Disease and QST Models

Diabetes, Oncology, Hematology, Liver Diseases, DILI, Cardiovascular, Ocular, Endocrine/Thyroid, Contraception, and more.
Find out more 

Related publications and initatives

Augmented allometric scaling: Predicting drug clearance in farm animalswith machine learning using body weight
A generic avian physiologically-based kinetic (PBK) model and itsapplication in three bird species
See all publications 

Meet the Team

Leonie Lautz

Scientist
Consultant
Google Scholar

Leonie Lautz is a Scientist at ESQlabs. Her work focuses on the development and application of harmonised methodologies applied to human health and animal health of chemicals, integration of cellular (in vitro) methods and computational models with a particular emphasis on kinetics and metabolism. Her research interests include physiologically based kinetic/dynamic modelling in livestock and laboratory animal species for next generation risk assessment. She is involved in projects related to veterinary pharmaceuticals, contaminants and feed/food safety.

After obtaining her BSc/MSc degree at the Radboud University Nijmegen, Leonie worked as scientific project leader at the French Agency for Food, Environmental and Occupational Health & Safety (ANSES, Paris, France). For this work, Leonie was awarded the SOT Exposure Specialty Section Best Abstract in 2020. In parallel to her work at ANSES, Leonie was appointed as junior researcher at Radboud University Nijmegen, where she obtained her PhD in veterinary toxicology/food safety in 2019. After that, she was employed at Wageningen Food Safety Research, where she was involved in/coordinated several projects for the European Food Safety Agency related to feed-food transfer and physiologically based kinetic modelling for livestock. Leonie was part of the international group that drafted the OECD GD on physiologically based kinetic models published in 2021.

Marco Siccardi

Principal Scientist
Lead Toxicology & PBPK
Google Scholar

Marco is a Clinical Biologist by training with a PhD in molecular pharmacology and PK/PD modelling. He spent over 15 years at the University of Liverpool working on the topic of pharmacogenetics and in developing PBPK approaches for the optimisation of drug delivery, including HIV therapy optimisation.

Marco has most recently been working with CROs in taking this approaches for modelling and simulation approaches and PKTK (Systems Toxicology) models across a number of disease areas.

Marco leads the Systems Toxicology team with the aim to promote collaborative innovation and to develop novel modeling approaches to streamline the toxicological assessment.

Vanessa Baier

Senior Scientist
Consultant & Operations Manager
Google Scholar

Vanessa Baier is bioinformatician by training, with a focus on computational modeling in the field of systems biology/systems pharmacology. She has experience with lab data management tools, Bayesian population PBPK techniques, and the contextualization of in vitro data and mechanistic PBPK models. Her main area at ESQlabs lies in vitro/in vivo extrapolation and toxicity modeling within PBPK QSP

Vanessa Baier studied computer science at TU Braunschweig and Bioinformatics at Goethe University Frankfurt. After an internship at Sanofi, she completed her master thesis at Bayer in the group of Complex Systems Modeling / Applied Mathematics. She then joined the group of Lars Kuepfer at RWTH Aachen University to complete her PhD on PBPK modeling of drug-induced liver injury (DILI) .