Skip to 0 minutes and 14 seconds Dear fellow student, this is Dr. Lee. I’m from Palm Beach Atlantic University. And in this slide, I’m showing you the building of our pharmacy school which is a five-story building. We do not quite have a ten-story building but we do have a five-story building which is also quite nice. I’m honored to be a visiting professor at TMU. And my office 710 on the seventh floor and also have the email address there. During my stay at TMU, I plan to videotape six unit of biotechnology mini lecture series And this six units are biotechnology history, biotechnology principles techniques and tools immunogenicity of biotechnology product formulation of biotechnology product, PK/PD correlations of biotechnology product and lastly, biotechnology product review.
Skip to 1 minute and 26 seconds And we are going to start out with biotechnology history today. The lecture materials come from these three reference books, textbooks. Since this lecture series is designed for pharmacy student, let me start out with the definition of medical product. Medical product include drugs which have referred to small-molecule chemical or molecular entities. Biologics. Product derived from biological source for example traditional vaccine, and blood product. So these are biological. the other category is biotechnology divide product which referred to monoclonal antibody and recombinant DNA product. And these are the product, the two categories of product that we are going to focus on medicinal product also includes medical devices, for example, a cardiac stem.
Skip to 2 minutes and 45 seconds Last but not least, diagnostic product, for example, the pregnancy test kit, the OTC pregnancy test kit, or the breast test for peptic ulcer. And of course, some biotech products are for diagnostic applications as well. How about pharmaceutical products? Pharmaceutical product referred to drugs and the biologics which are used for treatment or prevention of disease in humans or animals. Typically pharmaceutical products exclude devices and diagnostics. So pharmaceutical products include human drug product, veterinary drug product, And nowadays pharmaceutical products are not only intended for treatment and prevention of disease, but to improve the quality of life. For example, hair growth, anti-wrinkle skincare, sexual function, or gene therapy to reverse aging. Human drug products referred to drugs and biologics.
Skip to 4 minutes and 4 seconds A new drug application is abbreviated as NDA, new drug application. New drug application is reviewed and approved by CDER or Center for Drugs Education and Research in the United States. The new biologics application is called biological license application, or abbreviated as BLA. New biologics is reviewed and approved by CBER or Center for Biologics Education and Research. And in Taiwan, of course, both drugs and the biologics are reviewed by CDE Center for Drug Evaluation of the Taiwan FDA.
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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).
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