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

4.7
stars
2,403 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

PR

Dec 1, 2018

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

HD

Aug 2, 2020

Great introduction to the nuances of drug development, post research and into clinical and commercial aspects. I feel much more ready to enter the regulatory affairs arena after this.

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76 - 100 of 478 Reviews for Drug Development

By Christos S

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Jun 11, 2021

I learned a lot and I'm interested in doing more research on a number of different topics in this course. Definitely worth while.

By Pankaj K D

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May 6, 2020

such a great course where I found very important information. This course helps me to develop my knowledge about Drug Development

By Deepa P S

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Sep 20, 2020

Really useful course in knowing all the Phases of Drug development. I loved each and every lecture slide along wit the quiz

By Swarnadeep B

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May 13, 2020

Very good for a beginner as well for revising all basics of drug development, Thank you Coursera and UCsan Diego university

By Hiromi E T C

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Aug 19, 2023

Very informative and thoughtful about the problems of drugs and their impact through clinical trials for their development

By Prathap D

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Apr 9, 2020

The course designed very well, as i have been working in Regulatory Affairs, the content and discussions were very useful.

By Beatric S

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Sep 28, 2020

An excellent course for beginners well taught. The instructors experience make this course all the more clear and simple.

By Jessica B

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Feb 14, 2023

Quiz questions should be reviewed by instructors: there were a few typos and some confusing wording that should be fixed

By Vaishali k

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Jun 19, 2020

very useful and providing good knowledge which good information about the course .And teacher are very supportive .

By DR. R B

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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 Deleted A

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Apr 10, 2020

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

By Nidhi S

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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

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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

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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 Mostafa A

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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

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Jun 1, 2020

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

By MAITRI C T

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Aug 24, 2020

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

By Siddharth A I

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Jun 3, 2020

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

By Jayesh M

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Apr 6, 2023

This course was really helpful to me. i learnt lots of new things. looking forward for this type of courses.

By Vivek H R

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May 25, 2020

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

By FLOR D L A M

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Nov 3, 2020

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

By Philip L

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Nov 13, 2016

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

By Gagan C R

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Jul 20, 2024

I got to know about various aspects of drug development, drug approval etc. Overall it was a good course

By Afroj K

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May 13, 2020

Its A good Opportunity to learn the drug development.

very well explained.

thank you for such opportunity.

By Manish K

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Apr 26, 2020

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