Chevron Left
Back to Drug Development

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

4.7
stars
2,332 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

HG

Oct 15, 2018

Very well done and informative. I truly appreciate the Drug process in entirety being broken down into sections that are easy to comprehend. It is obvious the speakers were chosen for their knowledge.

KR

May 24, 2020

I am really glad to have course offered by california university . Its really helpful for me. And i am thankful to all lecturer, and teachers to explain overall drug development process.

Thank you!

Filter by:

176 - 200 of 466 Reviews for Drug Development

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 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

By Eduardo A

•

Dec 18, 2020

Very informative and great lectures!

By Akanksha S

•

Apr 20, 2021

this course is very helpfull for me

By Muhammad F R S

•

Jul 14, 2020

A course full of valuable contents.

By Dr. A A H (

•

Aug 20, 2019

I enjoyed the course very much.....