Overview of GCP and Clinical Trials in Drug Development

This document provides an introduction to Good Clinical Practice (GCP) and the drug development process.

It outlines the importance of GCP in ensuring ethical and high-quality clinical research, protecting participants, and maintaining scientific integrity.

The drug development process includes stages like preclinical research, clinical trials (Phases I-IV), and post-marketing surveillance.

Clinical trials are designed to test the safety, efficacy, and tolerability of new drugs, devices, or procedures, with each phase serving a specific purpose.

The document also highlights the role of regulatory bodies like the FDA and EMA, and the principles of ICH GCP guidelines, which emphasize ethical conduct, informed consent, and data integrity.