Unit Originally Created By:
CTE Online
Product Design, Procedures, Licensure and Regulations
Part of Course: Biotechnology Research and Development Model
Unit Overview / Details
In this unit, students will study biotechnology product design and development, laboratory procedures, product licensure, and the regulatory process for product development and clinical trials. Lessons address such topics as how pharmaceutical drugs are discovered and produced.
Instructional Hours
- Classroom/Lab
- 3 Weeks
Content / Concepts
- process of developing biotechnology products in an industrial setting
- the role of preclinical and clinical trials in biotechnology product development
- quality assurance in clinical trials
- California Career and Technical Education Standards: 7
- California Academic Content Standards: Reinforced: 11
- All Standards
- Full Details
- Industries and Pathways:
- Health Science and Medical Technology
Lessons in this Unit
Students learn what is involved in discovering a pharmaceutical drug. How drug targets are chosen, and the processes and stages involved in finding drug candidates to effect the targets.
- 1 - 2 class periods
- 55 Minutes
Students will conduct a long-term research project designed to guide them in understanding the stages in product development.
- Three classes
- 50 Minutes
- 7-10 weeks of student research out of class
- 10 - 15 Minutes
