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--- preclinical_animal_study [2025/07/06 08:01] – [Preclinical Animal Study] administrador
+++ preclinical_animal_study [2025/07/06 08:01] (current) – [📋 Regulatory Importance] administrador
@@ Line 36: / Line 36: @@
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-**Tags**: preclinical, animal study, safety, toxicity, IND, pharmacology, translational research
+====== 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 Alzheimer’s 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