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

2,117 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 (, Drug Development and 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


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!


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.

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76 - 100 of 421 Reviews for Drug Development

By DR. R B

Sep 6, 2020

I deem it a great pleasure and honor to have taken up the course in short time and able to understand concepts briefly

By Niki P

Apr 10, 2020

Excellent course with very well defined topics covered stepwise by experts in each field with real practical examples.

By Nidhi S

Apr 18, 2022

Thank you team Coursera for providing such useful course with lots amount of materials. Got to learn so many things.

By Luiz O L

Mar 14, 2021

Incredible classes with great content to learn how the whole process of the drug development occurs. I recommend it!

By Atharva S

Aug 29, 2020

Drug development is a plays a major role in pharmacy and the information given by all the professors is very helpful

By Moustafa A F A

Aug 20, 2020

It is very useful. I learnt all things related to drug development and it made me very happy it is very interesting.

By Mrinalini L R

Jun 1, 2020

A wonderful course that provides excellent insight into Drug development and clinical perspective of pharmaceuticals


Aug 24, 2020

A wonderful description about the happenings of the clinical trails, much needed information for pharmacy students

By Siddharth A

Jun 3, 2020

Really informative and nicely explained so that even beginners wouldn't have any issues understanding the topics.

By Vivek H R

May 25, 2020

Quite impressive and Informational course for any individual hoping to advance in the pharmaceutical sector

By Flor D L A M T

Nov 3, 2020

This is a truly great course for both professionals and students of Pharmacy and Pharmaceutical Sciences.

By Philip L

Nov 13, 2016

Excellent detailed course. Although US content. It is relevant since much development is done in the USA.

By Afroj K

May 13, 2020

Its A good Opportunity to learn the drug development.

very well explained.

thank you for such opportunity.

By Manish K

Apr 26, 2020

Excellent course taught be highly knowledgeable and experienced industry professionals and professors.

By Vikas K P

Sep 27, 2020

It was a good experience. Learned about drug development process step by step . it was just amazing.

By Ravi K R J

May 12, 2020

very useful for pharma regulatory graduates and professionals, thank you to coursera team...great job


May 23, 2020

I learned s many new things from this course. Thanks to every presenter, they are well experienced

By Gabriel R

Oct 24, 2019

an excellent course for those who want to understand better the whole process of Drug development.


Apr 29, 2020

This course is very good. A person from the pharmacy field gets to learn a lot from this course.

By aditya k

Aug 4, 2020

it was very helpful in understanding the ways pharma companies manage to get their products out.

By Diana M

May 22, 2020

Good course. But should be more updated information, if all the same regulation is still valid..

By Geeta M K

Aug 13, 2020

This course is very interesting and also it is useful to us in ur upcoming future 💯 thank you!

By Jonas D G

Jul 1, 2020

I really like the teachers and the Quiz. I hope this course will help me landing my next job!


Mar 11, 2020

Super interessante!! Me ajudou muito a entender sobre novos medicamentos e suas legislações!!

By Jony M

Mar 21, 2020

I have found this course good in terms of the content and lectures given by the instructors.