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

4.7
stars
2,270 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

DD

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Drug Development course is an Informative and Innovative and Help full for Development of the drug after Discovering it, and Kind Request to provide the Intermediate level and Advanced level courses.

PR

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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

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326 - 350 of 453 Reviews for Drug Development

By George W

Jul 5, 2019

This is an informative course on clinical trial development and regulatory considerations of drug development. However, I wish the course content is more updated and organized. The lecture videos are the just recordings from their classes in 2013.

By Lucia A

Mar 16, 2023

I was looking for a course that would give me a general idea of drug development and that could help me fill in the gaps that I had on this subject. I found this course very interesting and useful. The only flaw: it could be more up to date.

By Ashwini K

Jul 16, 2017

Course materials are useful, lectures are very easy to understand, some of the video / sound editing is a bit unclear, since you can't see the presenter talk when the slides are being shown. Overall, a great intro to drug development.

By Abram S

Jun 24, 2020

Robust review of the intricacies of the clinical trial process and economic considerations throughout. My only regret is that the data is a bit dated (ending 2012/13) and I am curious to see how things have shifted since then.

By Jonathan P

Apr 3, 2020

The course started well. But the course about Phase 2 was difficult to digest. Even worst, the course about NDA was long, repetitive, with old data (as old as 2003 !) and some regulation from 2009 ! It need a serious update.

By Amjad N

Mar 3, 2019

Overall, I liked this course. There are some improvements I would suggest: > list online resources more clearly > define acronyms and provide better definitions > quizzes need to be longer and slightly more challenging

By Subramanian K

Sep 2, 2017

The drug labeling seminar was not very informative. Both the presenters seemed to be wanting to go one-up on the other with their respective experiences. The entire session was too casual to be labeled as a lecture.

By Elena B

Apr 21, 2018

I would like to see more updated information (i.e. more information on biologicals), current presentation is a bit old (from 2008-2010?)

But it provides good general overview of the clinical development process.

By Divya G

Jun 12, 2021

I liked the content but I feel it wasn't very engaging and each slide had a lot of text. If there were peer review assignments and activities other than quizzes, the course would have been more interesting.

By viral p

Apr 29, 2021

The course was informative and found exactly at the time of need. I was a little disappointed because it's not the latest updated version. looking forward to the updated version of the course.

By Suda J

Aug 1, 2020

It is really informative and nice to learn about such a vast and growing industry. The only complain I have is all the data was from 2012 which has now either been changed or updated.

By Savind C

Jun 2, 2021

The course should be updated. Most of the data presented is almost a decade old. Also, The person who teaches about Phase II trails is not clear, and it is hard to understand him.

By Mary S

Jul 14, 2020

I would have loved to have a specific case study to follow as an example of how a drug goes through the whole life cycle as the course felt a bit too high-level overview at times.

By suzana

Nov 8, 2020

The course is well organized, but it requires an update of the contents.

It is good for starting and refreshing the topic of clinical trials. I look for the next updated one!

By Urjita J

Jun 1, 2020

Very detailed and conceptually clear information. lectures are very well designed for online learning. Good distribution of the entire drug dev. procedure. Learnt a lot!

By Hussein S

Nov 14, 2017

Provides a good overview on drug development phases and challenges. Some lecturers are from the industry which gives a practical feeling to the whole process.

By Sebastian F

Jan 24, 2021

Very well presented, very interesting. As many already mentioned unfortunately the material and data is a little out of date. Nevertheless, very good course.

By Muhamed S E

Aug 13, 2017

Great Course , although i had some hardships understanding some parts and i had to search it online on my own ,, but overall i would recommend it !

By yousef e

Sep 28, 2019

i think you should put the speaker talking videos also in the lec not only the slides this will give more intent to complete the course faster

By Karen O

Jun 30, 2020

Week 3 was the best! Both lecturers had loads of experience in industry, and shared all that knowledge with practical and real-life examples.

By Jahnavi

Oct 13, 2020

It is an amazing course that provides an practical insight into the field of clinical research. Thank you so much for your help and support.

By Álvaro S V

Mar 7, 2019

This course gives a wide overview about clinical trials and all the process needed to launch a new drug. I really enjoyed it.

By belmir a

Jul 26, 2022

one of the last pharmacist was terebal in explanation and her accent is unbelievable in bad way of course

Dr katie lyons

By Miguel M

May 26, 2022

Good seminars , however talks need to be updated to 2022.

New challenges afetr COVID19 must be taking in consideration

By Komal S

Jun 6, 2020

Very informative content with lot of information about working of pharmaceutical companies during development of drugs.