Course Overview

Hello, Learners! Whether you’re learning online for the first time, or you’re new to FutureLearn, the following tips will help you get the most out of your course.

Welcome to our clinical pharmacy series. I am Prof. Charles Lee the main educator of this course. Thanks to Shawn Hsiang-Yin Chen, Professor, Department of Clinical Pharmacy who help this course preparation.

Through this course, you’ll enhance your working knowledge of pharmacotherapy by understanding the principles and technologies of therapeutic protein products.

You’ll study the history and learn about the various techniques and tools involved in making biotechnology products. Through clinical research and case-based exercises, you’ll explore everything from immunogenicity and formulation to pharmacokinetics and pharmacodynamics.

This course will help you discover the full picture scope of biotechnology products from bench research to clinical use, and learn how to evaluate PK/PD correlations of biotechnology products.

To begin with, I will give a brief introduction of medical products, which comprise of (conventional) Drugs, Biologics, Devices, and Diagnostics, of which Biologics will be the subject of focus.

Biologics are pharmaceutical products that are derived from biological sources (e.g., porcine insulin) or biotechnological procedures (e.g., recombinant DNA for human insulin). However, agricultural products that are derived from biotechnology (e.g., disease-resistant corn) are generally not considered Biologics. Further, it is to be noted that new drugs are approved by CDER (Center for Drugs Education ) and biologics by CBER (Center for Biologics Education and Research) of the FDA (Food and Drug Administration). In Taiwan, the approval is authorized by TFDA/CDE (Taiwan Food and Drug Administration and Center for Drug Evaluation).

We hope you enjoy your learning!