MCB 6937 Regulatory Aspects of Microbiome-Based Therapies
- Credits: 1
- Prerequisites: MCB 6424 or MCB 4422
- When Offered: Summer C
- Syllabus: MCB 6937 Regulatory Aspects of Microbiome-Based Therapies
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 the 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
At a Glance
| Tuition | $535* per credit hour |
| Format | 100% Online |
| Credits | 30 Credit Hours |
| Application Deadlines | |
| Spring 2027 | November 15 |
| Summer 2027 | April 1 |
| No Application Fee | |