Chevron Left
Back to Drug Development

Learner Reviews & Feedback for Drug Development by University of California San Diego

4.7
stars
2,403 ratings

About the Course

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....

Top reviews

PR

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

HD

Aug 2, 2020

Great introduction to the nuances of drug development, post research and into clinical and commercial aspects. I feel much more ready to enter the regulatory affairs arena after this.

Filter by:

176 - 200 of 478 Reviews for Drug Development

By John A

•

Dec 2, 2020

the course is informative and easy to understand

By Pathak K J

•

May 29, 2020

Good for learning and thank you for your support

By Mrs. P S A

•

May 14, 2020

I loved to learning the drug development course.

By Samiya K

•

Jan 26, 2020

this course prooved to be really very beneficial

By Sneha B G

•

May 18, 2020

Best Course to Learn Drug development process.

By Shivam d

•

May 1, 2020

I found it more knowledge... Tq so much for it

By Saloni k

•

Jul 16, 2020

It was a very useful and knowledgeable course

By Dr H J

•

May 18, 2020

It was a NICE EXPERIENCE AND LOTS OF LEARNING

By Mritunjoy b

•

Jul 9, 2021

what a go....stay healthy have a proper diet

By ALISA C D

•

Aug 10, 2020

Very helpful. I got exactly what I expected.

By faryal f

•

Oct 1, 2019

it was very informative and i loved doing it

By Dr S A

•

Jul 31, 2021

best for basic learner in clinical research

By Jivesh G

•

Jun 24, 2020

Such an interesting and informative course.

By SYEDA K F

•

May 15, 2020

very nice effort by university of San Diego

By Beatrice M

•

Feb 15, 2017

Great Class. We need more of these courses.

By Abhishek P

•

Jun 20, 2020

Best course to give wide view into drugs

By Noor F M I

•

Jun 7, 2020

very beneficial class, easy to understand

By NIKITA K

•

Sep 7, 2024

This course is wonderful and informative

By George W

•

Oct 12, 2020

very well organized and very informative

By MUHAMMAD M A R

•

May 2, 2025

Remarkable and superb lecture delivery.

By Matías G

•

May 14, 2020

Very good intrudction to all the trials

By Abdulkader

•

Aug 11, 2019

Great course, well experienced teachers

By Refath R

•

Aug 11, 2021

I learned details on drug development.

By Larissa L G

•

Jun 11, 2020

Well structured and designed course!!

By Robert J L

•

Jan 30, 2024

I enjoyed this course and the detail