Show pageBacklinksCite current pageExport to PDFBack to top This page is read only. You can view the source, but not change it. Ask your administrator if you think this is wrong. ====== Preclinical Animal Study ====== A **preclinical [[animal study]]** is a type of [[scientific research]] conducted prior to initiating [[clinical trial]]s in humans. Its primary aim is to assess the **safety**, **toxicity**, **pharmacokinetics**, and often the **preliminary efficacy** of a proposed medical intervention. ===== ๐ Purpose ===== * To determine if a new drug, therapy, or device is **safe** and **potentially effective** before human testing. * To support regulatory submissions (e.g., [[FDA]] IND application). ===== ๐ Animal Models ===== * Use of animals that **mimic human disease** or relevant physiological conditions. * Common species: mice, rats, rabbits, pigs, non-human primates. * Models must demonstrate: * [[Biological relevance]] * [[Predictive validity]] for human outcomes ===== ๐ฌ Typical Assessments ===== * **Toxicity studies** (acute, subacute, chronic) * **Histopathological evaluation** * **Organ function monitoring** * **Drug absorption, distribution, metabolism, excretion (ADME)** * **Behavioral and neurological testing** (in neuro studies) ===== โ๏ธ Ethical Considerations ===== * Compliance with ethical standards and animal welfare laws * Implementation of the [[3Rs]]: - **Replacement** (use alternatives when possible) - **Reduction** (minimize number of animals) - **Refinement** (optimize procedures to reduce suffering) ===== ๐ Regulatory Importance ===== * Preclinical results are required to: * Define starting dose in human trials * Justify trial design and risk mitigation * Obtain approval for [[first-in-human studies]] ---- ====== Preclinical vs Experimental Animal Study ====== While closely related, **preclinical animal studies** and **experimental animal studies** are not exactly the same. Below is a structured comparison: ^ Feature ^ Preclinical Animal Study ^ Experimental Animal Study ^ | **Definition** | Subset of animal research aimed at clinical translation | Broad category of studies involving animals | | **Primary Purpose** | To evaluate safety, toxicity, pharmacokinetics, and preliminary efficacy before human trials | To explore biological mechanisms, disease models, or test hypotheses | | **Regulatory Context** | Required for regulatory submission (e.g., [[FDA]] IND) | Not necessarily linked to regulatory processes | | **Goal** | Support first-in-human trials | Generate scientific knowledge, may or may not be translational | | **Typical Outputs** | Data for dose selection, risk assessment, trial design | Mechanistic insights, disease modeling, biomarker discovery | | **Examples** | Testing new drug in mice before human trial | Studying gene expression changes in Alzheimerโs mice | | **Field** | Translational / applied research | Basic or applied research | | **Scope** | Narrower: focused on clinical applicability | Broader: includes all types of animal experimentation | ---- **Summary**: * All **preclinical animal studies** are **experimental**, * But not all **experimental animal studies** are **preclinical**. ---- **Tags**: preclinical, experimental, animal studies, translational research, basic science, IND preclinical_animal_study.txt Last modified: 2025/07/06 08:01by administrador