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Course Description
While early-stage drug design and development principles were discussed in PHA6444 Pharmaceutical Chemistry 1, this course will focus on additional in vivo testing and necessary data collection and condensation to meet the requirements for submission of an investigational new drug application (IND) to the US FDA. This is a critical step for a drug development company as it narrows down potential lead structures and seeks to gather essential information to ensure that the drug candidate can be approved for First-in-Human trials. An approval by the FDA is commonly associated with passing a hurdle to submit to other regulatory agencies such as the European Medicines Agency (EMA), Health Canada, or the Japanese Pharmaceutical and Medical Devices Agency (PDMA). All steps involved in gathering information and submitting an IND will be addressed in this course.
This course connects concepts covered in PHA6444 Pharmaceutical Chemistry 1 with late-stage cross-sectional drug design & development processes leading up to the IND submission:
- Justify the selection of appropriate data to include with the submission of an investigational new drug (IND) application
- Design a battery of pre-clinical tests that contribute to the requirements for the chemistry, manufacturing, and controls section of the IND submission
- Summarize and support the organizational structures that contribute to a successful and timely IND submission
- Align your current and future expertise within the process of preclinical drug design and development and how your position contributes to the success of a project
Course Goal
Although attempts have been made to streamline the application process to submit a new drug for clinical trials to various regulatory agencies, the intricate nature of the volume of data required for submission often requires coordination of various groups involved in preclinical drug development. Streamlining this process can be challenging given the nature of different locations and specializations that often prevents direct interaction or communication between researchers. Bridging such gaps by introducing an overview of the whole process from early to late preclinical drug development to submission of the IND will help everybody involved at various stages to better understand their critical and interdisciplinary role in bringing a new drug to market through this course.
Prerequisites
PHA6432 Fundamentals of Pharmaceutical Chemistry; PHA6444 Pharmaceutical Chemistry 1
* Important Note to Certificate & MS Students *
If you took PHA6444 Pharmaceutical Chemistry 1 prior to the spring 2018 semester, please instead enroll in the course PHA6935 Principles of Drug Action & Development 2
Topics
| Module | Topic |
|---|---|
| Module 1 | Components of an Investigational New Drug Application |
| Module 2 | Chemistry, Manufacturing, and Controls |
| Module 3 | Good Laboratory Practice |
| Module 4 | PD/PK in vivo drug development studies |
| Module 5 | In vivo disease models, correlations, and limitations |
| Module 6 | Toxicology studies to support First-in-Human trials |
| Module 7 | Allometric scaling, pharmacokinetics, and specific dosing considerations |
| Module 8 | First-in-Human trials and clinical trial design |
| Module 9 | Project management, organizational structure, and international regulations |
| Module 10 | Submission of an IND, final project |
Course Structure
Group discussion forums, online chat sessions, asynchronous mini-lectures, online timed quizzes, interactive animations, and individual e-mail contact between student and instructor. Students will be required to submit written essay assignments, record asynchronous presentations, as well as complete timed quizzes. The instructor will also be frequently available for one-on-one virtual office hours.
Required Materials
There is no single recommended text for this course. Helpful textbooks include:
- Drug-Like Properties: Concepts, Structure Design and Methods from ADME to Toxicity Optimization
Author: Li Di, Edward H Kerns
Publisher: Academic Press; 2nd edition (2016)
ISBN: 978-0128010761 - Basic Principles of Drug Discovery and Development
Author: Benjamin Blass
Publisher: Academic Press; 1st edition (2015)
ISBN: 978-0124115088 - Early Drug Development: Strategies and Routes to First-in-Human Trials
Author: Mitchell N. Cayen
Publisher: Wiley; 1st edition (2010)
ISBN: 978-0470170861 - Goodman & Gilman’s The Pharmacological Basis of Therapeutics
Author: Laurence L. Brunton, Bruce A. Chabner, Bjorn Christian Knollmann
Publisher: McGraw-Hill Professional; 12th edition (2010)
ISBN: 978-0071624428 - Foye’s Principles of Medicinal Chemistry
Author: Thomas L. Lemke, David A. Williams, Victoria F. Roche, S. William Zito
Publisher: Wolters Kluwer, Lippincott Williams & Wilkins; 7th edition (2012)
ISBN: 978-1609133450
Library Access
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