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

4.6
435 ratings
85 reviews

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 16, 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.

MR

Jul 19, 2018

Information in the course is very practical. I come from basic biology background and now with this course I gained some real insights about how the clinical trails happen.

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51 - 75 of 84 Reviews for Drug Development

By Eva K

Oct 24, 2019

Thank you, this course gave me basic understanding of drug development and clinical trials and I hope, it will help me to find new job position.

By Angel G R L

Oct 24, 2019

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

By David L

Oct 29, 2019

Could do with an update. It's 6 years old, much has changed.

By James D

Jan 15, 2019

Great course, but some of the information is becoming outdated due to the course being from 2013

By Jan B

Feb 26, 2019

An interesting introduction. It is more of an overview than an actual course. Would do again.

By Amjad N

Mar 04, 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 Álvaro S V

Mar 07, 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 Vanja T F

Feb 22, 2018

Very good talks and presentations, amazing speakers, lots of interesting information, very valuable course.

But OLD - the course needs major renewal, with new data and new talks. Same for power point presentations: most of them are totally useless, hard to understand and follow and just do not look nice. Please prepare better presentations for the next course.

By Hiep X N

Aug 05, 2017

Informative course, instructors have a great deal of industry experiences

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 Ashwini K

Jul 17, 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 Brendan D

Oct 15, 2017

Overall the content was relevant to drug development and presented in an organized manner. The presenters seemed to have a wealth of experience in development. This was my first time using Coursera and I enjoyed being able to pick up where I left off. I was disappointed with the course transcriptions as there were many inaccuracies.

By Muhammed T k

Sep 16, 2017

thanks ,it was interested

By Matthew K

Aug 03, 2017

Good primer on Drug Development albeit very high level.

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 Valery T

May 27, 2018

Thisa course was very intersting to learn more about new drug application 2 years before applying to the FDA, the week 2 and 3 clinical trials and regulatory aspects were very interesting. The format of assessment can be like content of 3/4 page and then the individual selects an option as to what to do to rectify the information. That is a more efficient process to creatively think and do the regulations job in a real world scenario. I had no hesitation in doing this course and would do it again. Very useful for my background of medical technician and analytical chemistry degrees.

By Pao-Sheng C

Mar 02, 2017

Brilliant framework and well designed structure

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 Subramanian K

Sep 03, 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 Alex

Apr 26, 2019

A very interesting lecture on drug development stages.

By Nana F

Jun 19, 2019

Very informative and useful course. Thank you very much to everyone who helped this work come to light

By George W

Jul 05, 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 IRINA B B G

Jul 30, 2019

Very easy to follow, fun, informal. Downside: speakers often talk in incomplete sentences, use inaudible terms.

By YOUSEF N K

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 Janet T

Oct 17, 2019

A great overview.