Chevron Left
Back to Drug Development

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

4.7
stars
2,024 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

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!

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.

Filter by:

1 - 25 of 410 Reviews for Drug Development

By Ekaterine B

Feb 20, 2018

By Cynthia V

Jan 28, 2020

By shaurya b

Jan 23, 2019

By Humberto M

Feb 26, 2018

By Dr.V.Padmavathi

Jul 4, 2020

By Miriam C

May 8, 2019

By Jesse G

Jan 18, 2021

By Philip R

Dec 2, 2018

By Adrián P F

Nov 12, 2018

By Emily K

Jan 23, 2020

By Dr. H R

Aug 29, 2018

By Michael D

Sep 2, 2018

By ANTONIOS M N C

Jun 3, 2018

By HASAN B

Mar 8, 2020

By Heather G

Oct 16, 2018

By Shyam P

Sep 14, 2019

By Giridhar R G

May 2, 2020

By Ahmed I I

Dec 30, 2019

By Radwa A M A E

Sep 21, 2019

By ABHINAV S

Apr 26, 2020

By Franceska F

Jan 12, 2020

By ELENA F D

Apr 29, 2020

By Yurshanva K

Sep 3, 2019

By Rosa E H E

Aug 7, 2019

By Bhavana S

Jul 2, 2020