Course Detail
Units:
6.0
Course Components:
Clinical
Enrollment Information
Enrollment Requirement:
Prerequisite: Pharm. D. student status
Description
At the completion of this clerkship, the student should be able to: Explain market trends and the generation of new product ideas; Describe safety and efficacy considerations in new product development; Follow the sourcing of raw materials, understand vendor certificates of analysis, and recognize the importance of the company's quality assurance process; Describe how pilot production parameters are applied to full-scale manufacturing of various dosage forms and how quality assurance procedures apply to all phases of production; Explain "Good Manufacturing Practices" and how they are used in the nutraceutical industry to satisfy FDA requirements; Explain the different regulatory requirements depending on the product and the country where it will be sold; Describe the role of the pharmacist in the nutraceutical industry.