Preclinical pharmacology is essential for assessing new drug candidates before human trials. At Biotest Facility, we focus on three key areas: pharmacokinetics, efficacy testing, and early toxicity.
Early toxicity studies identify potential adverse effects at various doses. This ensures the drug’s safety for further testing. Pharmacokinetic studies determine how the drug is absorbed, distributed, metabolised, and excreted, informing dosage and administration strategies. Efficacy testing evaluates a drug’s effectiveness in disease models that simulate human conditions, such as cancer and autoimmune disorders.
Biotest Facility provides an array of in vivo study formats, tailored to individual needs. Our preclinical pharmacology service ranges from tests on cells in multiwell plates to efficacy models in rodents. With the capacity to house up to 2,000 mice in IVC cages and 300 rats in Scantainers, we can support large-scale in vivo studies, ensuring flexibility and efficiency in your research.

Biotest Facility provides in vivo study formats, often tailored to individual needs. Our preclinical pharmacology service ranges from tests on cells in multi-well plates to efficacy models in rodents.
IN VIVO STUDIES
In vivo preclinical studies are crucial for understanding how a drug interacts with complex biological systems, often using rodents to closely mimic human physiology. These studies provide insights into the systemic effects of a drug, including its absorption, distribution, metabolism, excretion, and potential toxicity.
By observing the drug in a living organism, researchers can gather critical data on its overall safety and efficacy, which is necessary for advancing to clinical trials. In vivo models also allow for the testing of a drug’s efficacy in disease conditions that involve complex tissue interactions, providing a more accurate prediction of how the drug will perform in humans.

“…We handle a broad selection of preclinical research, from disease models to more general studies. Plus, we offer a wide variety of readout and reporting options to fit your needs…”
Preclinical in vivo studies at Biotest Facility

Understanding in vivo pharmacokinetics is essential for developing an effective dosing schedule. By studying how a drug is absorbed and eliminated, it is possible to determine the optimal timing and dosage to maintain therapeutic levels while minimising side effects.
LC-MS/MS FOR PK-PD STUDIES
At Biotest Facility, we offer advanced LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) services for in-depth analysis of small molecule drugs and their metabolites. LC-MS is a cornerstone technology in pharmacokinetic studies, providing highly sensitive and selective analysis of pharmaceutical compounds.
Our in-house Sciex QTRAP 4500 LC-MS/MS, a highly sensitive system designed for precise compound detection, combines high-pressure liquid chromatography (HPLC) with mass spectrometry. It can be used for detection of compounds, with a mass range of 5-2000 Da. This enables us to perform detailed analysis of small molecules in various biological matrices, including plasma, serum, whole blood, urine, and tissues, ensuring comprehensive PK/PD data.
ADME STUDIES
As part of our PK/PD services, we offer mass balance (ADME) studies to evaluate the processes of absorption, distribution, metabolism, and excretion of a drug. These studies provide critical data for understanding the drug’s behaviour in the body and inform decisions on dosing regimens and therapeutic strategies.
SAMPLE TYPES
- Plasma
- Serum
- Whole blood
- Urine
- Tissue

“…We can initiate PK and PD studies at short notice, and we provide supporting in-house analyses such as LC-MS/MS, qPCR, Nanostring, and proteomics…”
Preclinical in vivo studies at Biotest Facility
RNA MEDICINE
Over recent years, RNA-based therapeutics have made significant progress, particularly in treating genetic disorders. These therapies offer the potential to silence harmful genes, correct mutations, and induce immunity to infections. Targeting specific organs is a common approach, with the liver often chosen due to its central role in metabolism, and the central nervous system (CNS) in rare genetic conditions such as Huntington’s disease or Spinal Muscular Atrophy, as seen with the RNA therapeutic Spinraza. In these studies, both plasma and tissue samples are commonly analysed to evaluate the distribution, efficacy, and safety of RNA therapies.

Dosing to and sampling from the brains of rodents in PK and PD studies is essential for understanding drug interactions with the central nervous system. These methods inform research on neurological drugs and therapeutic strategies for brain-related disorders.
THE RODENT BRAIN
Dosing experimental compounds directly into the central nervous system during preclinical studies can be a necessary step for centrally acting drugs, particularly for compounds with poor blood-brain barrier (BBB) penetration or those that require extended time to reach equilibrium. Administering drugs in this manner helps study both CNS-specific side effects and on-target effects.
Sampling cerebrospinal fluid (CSF) allows for the assessment of pharmacokinetics within the brain and the evaluation of drug penetration across the blood-brain barrier (BBB). It also facilitates the measurement of brain-related biomarkers, offering valuable insights into drug efficacy and safety. These insights contribute to the refinement of therapeutic approaches in the central nervous system.
At Biotest Facility, we specialise in techniques for intracerebroventricular dosing, CSF sampling, and structured observation for potential CNS toxicity. This approach supports our preclinical evaluations and assists our sponsors in developing effective CNS-targeted therapies.
BEHAVIOURAL TOXICOLOGY
Structured observations of behavioural toxicity in preclinical studies serve to assess the impact of substances on neurological and psychological functions. The studies are typically carried out in mice and involve a panel of behavioural observations conducted according to a set schedule. These preclinical assessments provide important data on motor activity, reflexes, and autonomic functions, helping to understand the safety profile and potential central nervous system side effects of new compounds. Identifying signs of toxicity early in the preclinical process is valuable, as late discovery can lead to significant resource wastage and increased costs.

“…Chemicals don’t just damage cells—they can change behaviours. Focusing on behavioural toxicology in preclinical studies helps us identify early red flags…”
Preclinical in vivo studies at Biotest Facility

Preclinical efficacy studies compare the quantitative effects of a treatment to no treatment, helping to determine if the treatment has an adequate effect before moving to clinical trials.
DRUG EFFICACY
Efficacy studies in mice and rats provide valuable insights into the potential effectiveness of new treatments. By comparing the effects of a treatment to a control group that receives no treatment or a vehicle alone, we can quantify the treatment’s impact on various health outcomes. These studies help identify whether a treatment achieves the desired therapeutic effect and reveals dose-response relationships. Efficacy data helps determine if a treatment warrants progression to clinical trials.
While assessing effectiveness, we also observe for any potential adverse effects or unintended consequences that may arise from the treatment. The control group, which receives only the vehicle, helps distinguish between effects due to the treatment and those related to the administration process.
DISEASE MODELS – CANCER
Our mouse xenograft cancer model involves implanting human cancer cells or tissue into immunocompromised mice, allowing us to study tumour growth, progression, and response to treatments in a living organism. This model provides crucial insights into human cancer behaviour and therapy efficacy in a controlled, in vivo setting.
In contrast, mouse allograft model uses tumour cells or tissue from the same species, enabling the investigation of tumour interactions and immune responses with the host’s immune system fully active. Such models offer valuable understanding of cancer behaviour and treatment potential within a genetically similar host.
We are also equipped to provide a range of additional in vivo cancer models, including rat allograft and xenograft models, upon request. While these are not part of our standard offerings, our infrastructure allows us to accommodate these needs as required. Contact us to discuss how we can tailor our services to support your research.

As populations age, identifying mechanisms of ageing becomes increasingly important. Better understanding age-related diseases, along with drug kinetics and dynamics in the elderly, translates into improved quality of life and increased longevity.
STUDIES IN AGED ANIMALS
Preclinical studies in aged mice are valuable for understanding how treatments may affect older populations, which is crucial given the ageing demographics in many societies. Aged mice can be used to investigate age-related diseases, such as Alzheimer’s and Parkinson’s, or to study conditions that have unique manifestations in the elderly. Studies in aged animals are also important for evaluating the long-term safety and efficacy of drugs, considering the altered metabolism and immune response in older organisms.
The median lifespan of a laboratory mouse typically exceeds 2 years, with the maximum lifespan of a C57BL/6J strain approaching 36 months. Conducting research over these extended periods and managing increasingly frail animals presents unique challenges and requires a specialised skill set.
IMMUNOONCOLOGY
Immuno-oncology (IO) is a field of cancer research focused on harnessing the immune system to fight cancer. This approach involves understanding how immune cells interact with tumours and developing therapies that enhance or restore the immune system’s ability to target cancer cells. Immuno-oncology represents a shift from traditional cancer treatments, aiming for more precise and effective targeting with potentially fewer side effects.
Our facility is equipped to handle IO studies that are compatible with Animal Biosafety Level 1 (ABSL-1) standards. We have an attached cell laboratory that facilitates the cultivation and conditioning of both cancer cells and immune cells. This setup allows for the preparation of tumour cells for grafting, as well as the ex vivo expansion and activation of immune cells. By integrating these cell-based assays into our IO studies, we can provide a comprehensive platform for testing how immune therapies interact with cancer in a controlled environment.
TYPICAL IO READOUTS
- Tumour growth and regression
- Survival rates
- Immune cell profiling
- Histopathological analysis
- Biomarker analysis
IO TEST DRUGS
- Checkpoint inhibitors (e.g., anti-PD-1, anti-CTLA-4)
- Cancer vaccines
- CAR-T cell therapies
- Oncolytic viruses
- Immunomodulators

A rotarod test, used to assess motor coordination in Myasthenia Gravis research. Functional assays like this are essential for evaluating neuromuscular impairment and treatment efficacy in preclinical studies.
MYASTHENIA GRAVIS
Myasthenia Gravis (MG) is a chronic autoimmune disorder that significantly impacts the lives of those affected. Characterised by fluctuating muscle weakness and fatigue, the disease primarily targets the muscles controlling voluntary movements such as those involved in breathing, eye movement, and facial expressions. As the disease progresses, even routine tasks can become challenging, severely affecting the quality of life for individuals with MG.
MG is relatively rare, with an estimated prevalence ranging from 10 to 20 cases per 100,000 people worldwide, though the condition varies widely in severity and symptoms. It tends to affect people of all ages, but there are peaks in incidence among women in their 20s and 30s, and men in their 60s and 70s.
At the core of MG’s pathology is the production of autoantibodies that disrupt communication between nerves and muscles at the neuromuscular junction (NMJ). These autoantibodies most commonly target the acetylcholine receptors (AChR), leading to impaired muscle contraction. However, a subgroup of patients, about 5-8%, develop MG due to antibodies against muscle-specific receptor tyrosine kinase (MuSK), resulting in more severe symptoms and reduced responsiveness to conventional treatments.

“…We provide in vivo studies with expertise in both comprehensive molecular analyses and specialised functional assessments in rodents…”
Preclinical in vivo studies at Biotest Facility

Simple biomarkers, such as fever or sweet-smelling urine, have been recognised since antiquity. Today, biomarkers like human chorionic gonadotropin play a pivotal role in modern medicine, aiding both healthcare professionals and individuals—such as with at-home pregnancy tests—in making precise diagnoses.
BIOMARKER STUDIES
We offer a range of methods to study biomarkers across various molecular levels, including single molecules, DNA, RNA, peptides, proteins, and cells. Our techniques enable comprehensive analyses, from examining specific molecular entities to broader assessments of biomolecular interactions and functions.
In in vivo studies, monitoring established biomarkers provides valuable information for tracking the progression of a model disease or phenotype. Conversely, screening for new and unknown biomarkers can reveal insights into disease mechanisms and enhance diagnostics. Gene expression and multiplexed protein biomarker studies, in particular, present promising opportunities for discovering novel biomarkers and advancing personalised medicine.