====== Preclinical Experimental Study ====== **Definition:**\\ A **preclinical experimental study** is a type of biomedical research conducted **before** clinical trials in humans. It involves **in vitro (cell-based)** or **in vivo (animal)** models to investigate biological mechanisms, drug efficacy, toxicity, or disease processes. ---- === 🧪 Key Features === * **Subjects**: Non-human (e.g., rats, mice, pigs, or cell lines) * **Purpose**: To test hypotheses about disease mechanisms or potential treatments under controlled laboratory conditions. * **Interventions**: May involve drugs, gene therapy, surgical techniques, or physical devices. * **Endpoints**: Usually surrogate markers (e.g., protein expression, tumor volume, histological changes), **not clinical outcomes**. * **Level of evidence**: **Very low** for clinical decision-making; designed to support or generate hypotheses, not guide patient care. ---- === 🧠 Relevance in Neurosurgery === * Used to model neurological diseases (e.g., glioblastoma, spinal cord injury, intracranial aneurysms). * Common in vascular neurosurgery to study angiogenesis, venous hypertension, or response to new embolic agents. * Enables mechanistic insights prior to translation into human studies. ---- === ⚠️ Limitations === * **Species differences**: Animal physiology may not reflect human responses. * **Lack of external validity**: Artificially induced disease may not replicate human pathology. * **No clinical outcomes**: Cannot inform directly on therapeutic efficacy or safety in patients. * **Ethical considerations**: Must follow strict animal welfare protocols.