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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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351 - 375 of 453 Reviews for Drug Development

By Murali D

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Jul 9, 2020

The course is very good and gives an overview on clinical studies phase-1 -4. I enjoyed the lectures in this course.

By Muhamad A B A B

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Jul 8, 2020

Quite difficult to grasp for a newbie. Presentation slides are a bit boring and at certain point, difficult to read.

By Sanjida R M

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Mar 15, 2021

This course is very informative . I have learnt in details about IND, IRB review, about drug commercialization.

By Irina G

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Jul 30, 2019

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

By Claudia S

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Oct 3, 2021

the course gives a good overview of the approval process of drug products, however it is a bit outdated

By B M T I

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Jun 4, 2020

This course was really helpful to me.It helps me to know many unknown things.It was really good.Thanks.

By N. F

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Jun 19, 2019

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

By Anand A

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Jul 21, 2020

very good information provided in this videos by eminent people Thanks for this who has provided it.

By James D

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Jan 15, 2019

Great course, but some of the information is becoming outdated due to the course being from 2013

By Lavanya

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Feb 25, 2020

Excellent course material could understand the entire scenario of clinical trial as a beginner

By Jan B

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Feb 26, 2019

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

By KONDAPAKA S

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May 6, 2020

happy to learn new things regarding the drug development . thqnks for this great opportunity

By Nadia C

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Jan 30, 2020

some of the things was a little bit old - But i liked the content and the concepts

By Aderbal A

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Apr 18, 2021

the course is good, but classes are old and outdated. Many classes are lectures.

By Yury K

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Dec 2, 2019

Need to update the lectures to reflect rapidly changing regulatory issues

By Hiep X N

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Aug 5, 2017

Informative course, instructors have a great deal of industry experiences

By abbas a

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May 28, 2020

It was very helpful to me,and I learned much better in this quarantine.

By 树

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Aug 24, 2022

imformation in it is almost 10 years before,hope it could be updated

By Vindhya S R

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Nov 6, 2020

It was indeed a great course. It was quite informative. Thank you!

By Gaurav P

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Sep 16, 2022

Had amazing journey & great experience by learning this course.

By Morongwa L

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Mar 26, 2020

Thoroughly enjoyed this. Could do with an updating of materials.

By Ugbosu F O

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May 27, 2021

It was at first looking boring but i ended up having a nice time

By INMACULADA R L

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Sep 10, 2020

Me ha parecido muy interesante el mundo farmacéutico-industrial.

By shubham b

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Sep 20, 2021

i have learned all the phases in brief thanks to coursera .

By Matthew K

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Aug 3, 2017

Good primer on Drug Development albeit very high level.