Preclinical Drug Development and Translational Medicine Examination - Cheatsheet

# 🩺 Preclinical Drug Development and Translational Medicine - Study Guide ## 📋 Course Structure ``` 🏥 Preclinical Drug Development ├── 📖 Chapter 1: The Preclinical Profiling Phase │ ├── 🔹 Discovery to IND Transition │ ├── 🔹 Pharmacological Activity Evaluation │ └── 🔹 PK/PD Modeling ├── 📖 Chapter 2: Advanced In Vitro Systems │ ├── 🔹 2D vs. 3D Modeling (Spheroids) │ ├── 🔹 Blood-Brain Barrier (BBB) Co-cultures │ └── 🔹 Predictive Value and Hypoxia ├── 📖 Chapter 3: Safety and Toxicology Screening │ ├── 🔹 Cardiac Risk (hERG Assay) │ ├── 🔹 Genotoxicity (Ames Test) │ └── 🔹 Regulatory Prerequisites ├── 📖 Chapter 4: In Vivo Experimental Models │ ├── 🔹 Outbred vs. Inbred Strains │ ├── 🔹 Humanized Mouse Models │ └── 🔹 Patient-Derived Xenografts (PDX) └── 📖 Chapter 5: Ethics and Non-Invasive Imaging ├── 🔹 The 3Rs Principle ├── 🔹 Optical Imaging (Bioluminescence/DLIT) └── 🔹 Multispectral Optoacoustic Tomography (MSOT) ``` ## 📖 Chapter 1: The Preclinical Profiling Phase **What this chapter covers:** This chapter details the strategic bridge between initial chemical discovery and the filing of an Investigational New Drug (IND) application. It focuses on characterizing the drug's "profile" through pharmacological activity, safety, and metabolic behavior.