About this Course
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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....
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100% online courses

Start instantly and learn at your own schedule.
Calendar

Flexible deadlines

Reset deadlines in accordance to your schedule.
Beginner Level

Beginner Level

Clock

Suggested: 3-4 hours/week

Approx. 8 hours to complete
Comment Dots

English

Subtitles: English

Skills you will gain

Clinical ResearchDrug DevelopmentClinical Trial DesignClinical Development
Globe

100% online courses

Start instantly and learn at your own schedule.
Calendar

Flexible deadlines

Reset deadlines in accordance to your schedule.
Beginner Level

Beginner Level

Clock

Suggested: 3-4 hours/week

Approx. 8 hours to complete
Comment Dots

English

Subtitles: English

Syllabus - What you will learn from this course

1

Section
Clock
3 minutes to complete

Welcome!

...
Reading
1 video (Total 3 min)
Video1 video
Clock
1 hour to complete

Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.

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....
Reading
5 videos (Total 46 min), 2 readings, 1 quiz
Video5 videos
Regulatory Considerations When Filing an Investigational New Drug Application II11m
Regulatory Considerations When Filing an Investigational New Drug Application III9m
Regulatory Considerations When Filing an Investigational New Drug Application IV8m
Regulatory Considerations When Filing an Investigational New Drug Application V6m
Reading2 readings
Lecture Slidesm
A new Master Degree in Science in Drug Development & Product Management at UCSD10m
Quiz1 practice exercise
Regulatory Considerations When Filing an Investigational New Drug Application Quiz14m
Clock
1 hour to complete

Clinical Study & Start-up Activities, Joseph Ma, Pharm.D.

This module is presented by Dr. Joseph Ma, Associate Professor in the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences....
Reading
5 videos (Total 43 min), 1 reading, 1 quiz
Video5 videos
Clinical Study & Start-up Activities II10m
Clinical Study & Start-up Activities III6m
Clinical Study & Start-up Activities IV6m
Clinical Study & Start-up Activities V8m
Reading1 reading
Lecture Slidesm
Quiz1 practice exercise
Clinical Study & Start-up Activities Quiz14m

2

Section
Clock
1 hour to complete

Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.

This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer....
Reading
5 videos (Total 46 min), 1 reading, 1 quiz
Video5 videos
Clinical Trials: Phase 1 Part II10m
Clinical Trials: Phase 1 Part III12m
Clinical Trials: Phase 1 Part IV9m
Clinical Trials: Phase 1 Part V5m
Reading1 reading
Lecture Slidesm
Quiz1 practice exercise
Clinical Trials: Phase 1 Quiz12m
Clock
1 hour to complete

Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.

Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer...
Reading
5 videos (Total 47 min), 1 reading, 1 quiz
Video5 videos
Clinical Trials: Phase 2 Part II10m
Clinical Trials: Phase 2 Part III10m
Clinical Trials: Phase 2 Part IV10m
Clinical Trials: Phase 2 Part IV5m
Reading1 reading
Lecture Slidesm
Quiz1 practice exercise
Clinical Trials: Phase 2 Quiz10m

3

Section
Clock
1 hour to complete

Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.

...
Reading
5 videos (Total 44 min), 1 reading, 1 quiz
Video5 videos
Industry Considerations with Phase III Clinical Trials II10m
Industry Considerations with Phase III Clinical Trials III10m
Industry Considerations with Phase III Clinical Trials IV7m
Industry Considerations with Phase III Clinical Trials V4m
Reading1 reading
Lecture Slidesm
Quiz1 practice exercise
Industry Considerations with Phase III Clinical Trials Quiz14m
Clock
1 hour to complete

New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.

...
Reading
6 videos (Total 55 min), 1 reading, 1 quiz
Video6 videos
New Drug Application, Filing, Product Labeling II10m
New Drug Application, Filing, Product Labeling III8m
New Drug Application, Filing, Product Labeling IV8m
New Drug Application, Filing, Product Labeling V9m
New Drug Application, Filing, Product Labeling VI8m
Reading1 reading
Lecture Slidesm
Quiz1 practice exercise
New Drug Application, Filing, Product Labeling Quiz10m

Instructors

Williams S. Ettouati, Pharm.D.

Director, Industrial Relations & Development; Health Sciences Associate Clinical Professor, N.S.
Skaggs School of Pharmacy and Pharmaceutical Sciences

Joseph D. Ma

Associate Professor of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences

About University of California San Diego

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....

Frequently Asked Questions

  • Once you enroll for a Certificate, you’ll have access to all videos, quizzes, and programming assignments (if applicable). Peer review assignments can only be submitted and reviewed once your session has begun. If you choose to explore the course without purchasing, you may not be able to access certain assignments.

  • When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.

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