Preclinical testing in animal models

Preclinical testing in animal models is a critical component of pharmaceutical research at the Academy of Medical Sciences, Vietnam (AMS Vietnam). This stage of research provides essential scientific evidence on safety, pharmacological activity, and biological mechanisms before a candidate product progresses to human clinical trials. Through rigorously designed preclinical studies, AMS Vietnam ensures that pharmaceutical development is grounded in robust data, ethical responsibility, and regulatory compliance.

As part of its broader pharmaceutical research mission, AMS Vietnam conducts preclinical studies to evaluate novel compounds, herbal-derived products, biologics, and advanced formulations. These studies form the scientific foundation for decision-making in drug development, risk assessment, and clinical trial design.

Preclinical testing represents the bridge between laboratory discovery and clinical application. At AMS Vietnam, animal-based studies are used to:

• Evaluate pharmacological efficacy and mechanism of action
• Assess acute, subacute, and chronic toxicity
• Determine pharmacokinetics and pharmacodynamics
• Identify potential target organs and adverse effects
• Establish safe starting doses for human studies

Data generated during this phase are essential for regulatory submissions and ethical approval of clinical trials. By systematically assessing both therapeutic potential and safety risks, preclinical testing reduces uncertainty and protects human research participants.

Animal models play a vital role in understanding complex biological processes that cannot be fully replicated through in vitro or computational methods alone. AMS Vietnam selects animal models based on scientific relevance, biological similarity to human physiology, and the specific research objectives of each study.

Commonly used models include rodents and other validated species appropriate for toxicological, pharmacological, and disease-specific investigations. Model selection is guided by internationally recognized scientific standards and tailored to the pharmacological class and intended clinical use of the investigational product.

Preclinical testing at AMS Vietnam encompasses a comprehensive range of studies, including:

Pharmacological Efficacy Studies

These studies evaluate whether a candidate pharmaceutical produces the intended biological or therapeutic effect. Disease-specific animal models are used to assess efficacy, dose–response relationships, and duration of action.

Toxicology and Safety Assessment

Safety evaluation is a core focus of preclinical research. Studies are conducted to assess:

• Acute and repeated-dose toxicity
• Target organ toxicity
• Genotoxicity and carcinogenic potential, where applicable
• Reproductive and developmental toxicity

These assessments help identify potential risks and define safety margins.

Pharmacokinetics and Bioavailability

Preclinical pharmacokinetic studies investigate absorption, distribution, metabolism, and excretion (ADME) profiles. These data inform formulation optimization, dosing regimens, and clinical trial planning.

Specialized and Mechanistic Studies

When required, AMS Vietnam conducts mechanistic studies to elucidate molecular pathways, biomarkers, and interactions with biological systems. These studies enhance scientific understanding and support translational relevance.

The Academy of Medical Sciences, Vietnam is committed to the highest ethical standards in preclinical research. All animal studies are conducted under strict ethical oversight and in accordance with national regulations and internationally accepted principles for animal care and use.

Key ethical commitments include:

• Justification of animal use based on scientific necessity
• Application of the principles of Replacement, Reduction, and Refinement (3Rs)
• Minimization of animal discomfort and distress
• Use of humane endpoints and appropriate anesthesia or analgesia
• Oversight by institutional ethics committees

AMS Vietnam continuously evaluates alternative methods and emerging technologies to reduce reliance on animal models where scientifically feasible.

Preclinical testing at AMS Vietnam is supported by specialized research facilities designed to ensure data reliability, biosafety, and regulatory compliance. These facilities include controlled animal housing environments, laboratory spaces for pharmacological and toxicological analysis, and advanced analytical platforms.

Technical teams comprise experienced researchers, veterinarians, laboratory scientists, and quality assurance personnel. Continuous training and adherence to standard operating procedures ensure consistency and reproducibility across studies.

Quality assurance is integral to all preclinical activities at AMS Vietnam. Studies are designed and conducted in alignment with Good Laboratory Practice (GLP) principles, where applicable, and with regulatory expectations of Vietnamese authorities and international agencies.

Documentation, data management, and reporting processes are structured to support regulatory submissions, scientific review, and audit readiness. This commitment to quality ensures that preclinical data generated by AMS Vietnam are credible, transparent, and suitable for use in subsequent clinical development.

Preclinical testing at AMS Vietnam is not conducted in isolation. Findings are closely integrated with downstream clinical and translational research programs. Cross-functional collaboration between preclinical scientists, clinicians, and regulatory experts ensures continuity across development stages.

This integrated approach enables:

• Evidence-based clinical trial design
• Rational dose selection for first-in-human studies
• Early identification of translational challenges
• Efficient progression from research to application

By aligning preclinical and clinical perspectives, AMS Vietnam enhances the likelihood of successful development outcomes.

AMS Vietnam’s preclinical research capabilities support a wide range of pharmaceutical development initiatives, including:

• New chemical entities and biologics
• Herbal-derived and traditional medicine-based products
• Reformulation and optimization of existing drugs
• Biosimilar and combination products

Through collaboration with academic partners, healthcare institutions, and industry stakeholders, the Academy contributes to innovation across the pharmaceutical pipeline.

The ultimate purpose of preclinical testing at the Academy of Medical Sciences, Vietnam is to contribute to safer, more effective therapeutic options for patients. By generating high-quality scientific evidence early in development, AMS Vietnam supports responsible innovation that aligns with public health priorities.

Beyond individual projects, preclinical research strengthens national research capacity, advances scientific knowledge, and enhances Vietnam’s role in the global pharmaceutical research landscape.

Looking ahead, AMS Vietnam will continue to refine and expand its preclinical testing capabilities. Strategic priorities include the adoption of advanced biomarkers, integration of computational modeling, and increased use of alternative and complementary research methods where appropriate.

Through continuous improvement and adherence to scientific and ethical excellence, the Academy of Medical Sciences, Vietnam remains committed to advancing pharmaceutical research that is rigorous, responsible, and impactful.