In the high-stakes journey of modern biomedical research and drug development, murine models—specifically specialized strains of mice (Mus musculus) and rats (Rattus norvegicus)—remain the foundational pillars of preclinical animal testing. As well-established model organisms, rodents are indispensable for understanding disease mechanisms, evaluating drugs tested in vivo, and generating regulatory-ready data.
Why Murine Models Remain Central to Preclinical Drug Development
Translational Value: Why Mouse and Rat Models Dominate Preclinical Research
Specialized Applications in Advanced Therapeutics
Pharmacokinetics (PK), ADME, and Bioavailability
Global Regulatory Compliance (FDA / EMA / NMPA)
Strategic Advantages of Partnering with HuaTeng Biotechnology
Why Murine Models Remain Central to Preclinical Drug Development
From early-stage target validation and mechanism-of-action (MoA) studies to complex IND-enabling safety, pharmacokinetics (PK), and toxicology assessments, mouse and rat models offer an unparalleled combination of genetic malleability, physiological relevance to the human body, scalability, and global regulatory acceptance.
For global biopharmaceutical innovators and preclinical CRO partners, selecting the optimal animal research strategy is not merely a logistical decision—it is a strategic imperative. Whether leveraging genetically engineered mouse models for oncology or high-fidelity rat models for behavioral neuroscience, the quality and translational relevance of preclinical animal testing data directly dictate downstream clinical success.
Translational Value: Why Mouse and Rat Models Dominate Preclinical Research
While larger species may offer certain anatomical similarities to humans, mice and rats provide a high-throughput, genetically diverse research platform that is essential for precision medicine, pharmacological screening, and regulatory-aligned drug development.
Decades of characterization of the mouse genome, combined with strong genetic similarity in disease-relevant pathways, make rodents the preferred species for hypothesis-driven animal experimentation throughout the drug development life cycle.
1. Advanced Genetic Engineering: The Power of GEMMs and Humanized Mice
Genetically engineered mouse models (GEMMs) are among the most powerful tools in contemporary biomedical research, enabling precise genetic manipulations of specific genes to recapitulate human disease at the molecular level.
(1) Precision Gene Editing
Using advanced CRISPR/Cas9 and Cre-LoxP systems, GEMMs allow for tissue-specific, inducible, or conditional gene deletions and knock-ins. These approaches are widely applied to model:
- Human cancers
- Rare genetic disorders
- Metabolic and inflammatory diseases
Such models are critical for mechanistic discovery and in vivo validation of novel therapeutic targets.
(2) Humanized Immune System Mouse Models
To evaluate advanced immuno-oncology (IO) therapeutics, humanized mice—such as NPG/hCD34⁺ models reconstituted with human cells—are essential. These models enable the study of human-specific immune responses that cannot be replicated in conventional rodent strains.
Applications include evaluation of:
- Immune checkpoint inhibitors (PD-1/PD-L1, CTLA-4)
- Bispecific antibodies
- CAR-T and other cell-based therapies
Humanized mouse models bridge the translational gap between rodent biology and the human immune system, strengthening IND-enabling efficacy packages.
2. Metabolic and Cardiovascular Sophistication in Rat Models
In many areas of animal research and preclinical animal testing, rats are preferred over mice due to their larger size, superior surgical tolerance, and more complex hormonal and metabolic profiles.
(1)Hypertension and Metabolic Syndrome
Specialized rat strains such as the:
- Spontaneously Hypertensive Rat (SHR)
- SHR/cp obese hypertensive rat model
are considered gold standards for evaluating antihypertensive agents, anti-diabetic drugs, and therapies targeting metabolic syndrome and insulin resistance.
(2)Cardiovascular Hemodynamics and Safety Pharmacology
The physiological robustness of rats facilitates:
- LAD coronary artery ligation for myocardial infarction models
- Radio-telemetry–based real-time blood pressure and ECG monitoring
- Serial blood sampling in living animals for PK and toxicokinetic analysis
These features make rat models indispensable in IND-enabling cardiovascular and safety pharmacology studies.
Specialized Applications in Advanced Therapeutics
1. Immuno-Oncology: Beyond Tumor Growth Inhibition (TGI)
Modern oncology research requires more than tumor volume measurements; it demands a comprehensive understanding of immune dynamics within the tumor microenvironment (TME).
At HuaTeng Biotechnology, animal testing laboratories support:
- Syngeneic tumor models in immunocompetent mice
- Evaluation of immune–tumor interactions
- Advanced TME analysis, including Tumor-infiltrating lymphocytes (TILs), Cytokine and chemokine profiling
These studies support mechanism-of-action–driven animal experimentation for biologics and combination therapies.
2. Metabolic Dysfunction and NASH/MASH Models
Metabolic dysfunction–associated steatohepatitis (MASH) requires animal models that accurately reflect disease progression in the human body.
- Diet-induced obesity (DIO) models in mice and rats
- Disease progression from steatosis to inflammation and fibrosis
- Integrated efficacy endpoints combining Histopathology (NAS score, fibrosis staging), Serum biochemistry and metabolic biomarkers
These preclinical animal testing platforms are widely used to evaluate lipid-lowering, anti-fibrotic, and metabolic pathway–targeted therapeutics.
3. CNS and Behavioral Neuroscience Research
Rats remain the preferred species for behavioral neuroscience and CNS pharmacology, owing to their superior cognitive and behavioral complexity.
Key offerings include:
- Transgenic mouse models (APP/PS1, 5xFAD) for Alzheimer’s disease
- Neuroinflammation and synaptic biomarkers
- Behavioral phenotyping using Morris Water Maze, Open Field Test, and Elevated Plus Maze
These assays support functional evaluation of CNS drugs tested prior to clinical translation.
4. Nephrology and Fibrosis Models
Chronic kidney disease (CKD):
- 5/6 Nephrectomy rat model
- Unilateral Ureter Obstruction (UUO) mouse model
Idiopathic pulmonary fibrosis (IPF)
- Bleomycin-induced lung fibrosis models in rats
These rodent models are widely accepted in preclinical animal testing services supporting anti-fibrotic drug development.
Pharmacokinetics (PK), ADME, and Bioavailability
Rats are the preferred species for PK and ADME animal testing, enabling:
- Serial blood sampling with minimal stress
- PK/PD modeling to support first-in-human (FIH) dose selection
- Bioavailability assessment via oral (PO) and intravenous (IV) routes
- Determination of half-life, clearance, and systemic exposure
Global Regulatory Compliance (FDA / EMA / NMPA)
Animal testing for drug development is explicitly required or strongly recommended by global regulatory agencies.
- Two-species toxicology requirement (rodent + non-rodent)
- Identification of systemic toxicity and dose-limiting toxicity (DLT)
- Alignment with:
ICH S1A–S1C (carcinogenicity studies)
ICH S3A (toxicokinetics)
ICH S9 (nonclinical evaluation for anticancer pharmaceuticals)
Strategic Advantages of Partnering with HuaTeng Biotechnology
As a trusted global preclinical CRO and animal testing company, HuaTeng Biotechnology delivers high-quality, compliant data that supports successful IND submissions.
Our advantages include:
- AAALAC-accredited animal facilities
- OECD GLP–compliant animal testing services
- Large-scale rodent colony management for speed and consistency
- Custom CRISPR-based and humanized mouse model development
- Integrated in vivo efficacy, PK, and toxicology platforms
De-Risk Your Preclinical Program with HuaTeng Biotechnology
High-quality animal research remains essential for translating scientific discovery into safe and effective medicines.
At HuaTeng Biotechnology, we combine deep biological expertise with advanced in vivo platforms to deliver IND-ready preclinical animal testing data that regulators trust and sponsors rely on.
Ready to accelerate your drug development journey?
Contact HuaTeng Biotechnology today to design a tailored mouse or rat study that withstands regulatory scrutiny and shortens the path to the clinic.
