Public Health Informatics: The Intersection of Data and Health
February 13, 2024
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This course is part of Drug Development Product Management Specialization
Instructors: Williams S. Ettouati, Pharm.D.
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The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development.
In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally you will learn how to Incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas. In this course you will learn the different phases of clinical development: * Phase 1 or early stage clinical trial are conducted primarily to determine how the new drug works in humans, its safety profile and to predict its dosage range. It typically involves between 30 and 100 healthy volunteers. * Phase 2 or Proof of Concept POC studies test for efficacy as well as safety and side effects in a group of between 30 to 200 hundred patients with the disease for which the new drug is being developed. * Phase 3 or late stage clinical development involve much larger group of patients, between a few hundred to thousands, depending on the indication, which will help determine if the new drug can be considered both safe and effective. It will involve control groups using placebo and/or current treatment as a comparison. * Product registration and approval process after a drug is considered safe and effective from Phase 3 trials, it must be authorized in each individual country before it can be marketed. All data generated about the small molecule or biologic is collected and submitted to the regulatory authorities in the US at the FDA, Food and Drug Administration FDA, in Europe the EMA or European Medicines Agency, Japan Ministry of Health and other countries which may require their own national approvals. This course is intended as part 2 of a series: Drug Discovery (https://www.coursera.org/learn/drug-discovery), Drug Development and Drug Commercialization (https://www.coursera.org/learn/drug-commercialization). We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place.
This week we hear from Dr. Susan Trieu, who in her 12+ years in the industry has worked in regulatory affairs. Since then, Dr. Trieu has gone on to work in Industry at MedImpact as their Drug Information Pharmacist.
5 videos2 readings1 assignment3 discussion prompts
This module is presented by Dr. Joseph Ma, Associate Professor in the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences.
5 videos1 reading1 assignment1 discussion prompt
This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer.
5 videos1 reading1 assignment1 discussion prompt
Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer
5 videos1 reading1 assignment1 discussion prompt
5 videos1 reading1 assignment3 discussion prompts
6 videos1 reading1 assignment2 discussion prompts
We asked all learners to give feedback on our instructors based on the quality of their teaching style.
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 10 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom—life is their laboratory.
University of California San Diego
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University of California San Diego
Specialization
University of California San Diego
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Specialization
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Reviewed on Dec 1, 2018
Fantastic course, learned a lot of new things. Will go for the drug discovery course next. Consider including the presentations before the tests rather than afterwards
Reviewed on Aug 21, 2021
It is a great pleasure for me to complete successfully this course and thanks to the course coordinators and teachers. This course will open my bright future to the pharmaceutical career.
Reviewed on Jun 1, 2021
The course should be updated. Most of the data presented is almost a decade old. Also, The person who teaches about Phase II trails is not clear, and it is hard to understand him.
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