Preclinical studies

Jump to Drug formulation — Toxicology — Pharmacokinetics (PK) — Pharmacodynamics (PD) — Non-cancer PD/efficacy studies

Drug formulation

With deep experience in first-in-vivo compounds, we support the optimization of formulation and dosing strategies for discovery-stage drugs that have never been tested in animal models. When appropriate, pharmacokinetic-driven bioavailability studies are integrated to define optimal dosing regimens and routes of administration. [Back to top]

Toxicology

We perform comprehensive in vivo toxicological profiling to assess the safety of candidate drug compounds. The following evaluations are routinely conducted: 

• Maximum tolerated dose (MTD)
• Hematology (CBC with differential)
• Clinical blood chemistry
• Liver enzyme analysis
• Histopathological evaluation

In vitro toxicity testing and custom assays can be performed, depending on availability of required equipment and expertise. [Back to top]

Pharmacokinetics (PK)

We conduct standard serum and plasma pharmacokinetic (PK) analyses to evaluate bioavailability, peak concentration C_max, and half-life (T^1/2). PK data are used to inform optimal dose selection, dosing frequency, and routes of administration for in vivo efficacy studies.

Quantification methods routinely employed include:

• LC–MS/MS (small molecules, peptides)
• HPLC (small molecules, nanoparticles)
• ELISA (proteins)
• Quantitative PCR (nucleic acids)

Advanced PK studies—including efficacy-linked PK and tissue distribution analyses—are available through customized experimental designs. [Back to top]

Pharmacodynamics (PD)

We conduct in vivo pharmacodynamic and efficacy studies across a wide range of cancer models to support preclinical drug evaluation. Studies can be performed using single-agent monotherapy or in combination with standard-of-care (SoC) therapies.
Our extensive experience enables informed recommendations on model selection, dosing regimens, combination strategies, and appropriate SoC comparators, minimizing the need for extensive optimization and saving significant time and cost.

Study endpoints may include:

• Tumor growth inhibition (TGI)
• Survival
• Disease recurrence
• Additional efficacy and response biomarkers, as appropriate [Back to top]

Non-cancer PD / efficacy studies

Our expertise extends beyond oncology. We support model development and in vivo efficacy studies in additional disease areas, including autoimmune and infectious diseases.

Please contact us to discuss feasibility and study design for pharmacological efficacy evaluations in your model of interest. [Back to top]