MCB 6937 Regulatory Aspects of Microbiome-Based Therapies

Credits: 1

Tuition: $535

Syllabus: Coming Soon

Description

This course will cover guidelines published by the Food and Drug Administration for live biotherapeutic products, basic aspects of clinical research and primary research papers covering various aspects of the use of microbiome-derived species to modulate the health status in the host.

Course Goals

After successful completion of this course, students will be able to:

• Read primary research publications (papers) in the microbiome
• Learn the regulatory pathways available for live biotherapeutic products
• Understand the elements needed in different types of clinical trials.
• Evaluate primary literature on clinical trials and the methods utilized
• Comprehend data presented in figures, tables, and text within research papers
• Determine if experiments have been conducted with appropriate controls
• Determine if research conclusions for specific experiments and the paper overall are justified by the presented data
• Examine the current literature for related papers and discuss those papers
• Understand the difference between a primary research paper and a review or news piece.
• Examine the different regulatory pathways available for microbiome products
• Understand the differences between food supplements, medical foods and biologics
• Learn the FDA/CBER guidelines for the development and testing of live biotherapeutic products

Library Access

Distance Education and UF Online Students enjoy the same library privileges as on-campus students.

• Utilize the University of Florida Library System