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

4.7
stars
2,332 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

HG

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.

KR

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!

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401 - 425 of 466 Reviews for Drug Development

By ABHIJEET N

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Jul 28, 2020

need more elaborated lectures

By Kurre B

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Jul 5, 2020

Nice and very well explained

By MUSAIB Z

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May 27, 2020

This course was very useful

By Mohsen C

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Jun 10, 2024

Don't lose the week three!

By m_taisir k

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Sep 16, 2017

thanks ,it was interested

By Kiran

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May 28, 2020

very useful to beginners

By Seema A G

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Apr 22, 2020

Very informative course.

By Himanshi S

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Aug 17, 2020

very good experience

By Manda L p

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Jun 4, 2020

very helpful course

By Janet T

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Oct 17, 2019

A great overview.

By KAVITHA C 2

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Feb 11, 2024

easy and awesome

By Nilanjan P

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Nov 30, 2019

excellent course

By SK S R

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Feb 15, 2024

knoledgable

By Sivanaga V M

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Nov 23, 2020

Good course

By Jakka B

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Aug 28, 2020

Informative

By Shivani

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Jul 24, 2020

It is good

By EARRA S

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May 30, 2020

Use full

By Ahmed S

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Jul 22, 2022

Great!

By Dr. S U

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Aug 24, 2020

useful

By Rumana F H A

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Nov 18, 2022

good

By AMAN V

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Sep 7, 2020

good

By Shweta S

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May 9, 2020

nice

By عزالدين ه

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Oct 14, 2024

جيد

By Paul G

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Jun 19, 2020

The information provided by this course was very helpful for someone who is new to the topic and I do feel much better informed as a result. The course itself however is not the most professionally presented. The recordings are of face to face lectures provided to an actual class of students. As such they are designed for online learning where there is no possibility to interact with the speakers and students don't have access to any other course materials. The speakers in the phase 3 and marketing sections didn't really follow their slide packs.

By Eliza V

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Jul 16, 2017

The overall material was good. However, the course was not structured as an online course, rather an online posting of in class lectures. This made it difficult to hear the questions of the students as the questions were not repeated by the lecturer and therefore we received an answer to a question we didn't hear. Also, because of the lecture nature, a lot of information was missing from the slides as it was spoken information.