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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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301 - 325 of 466 Reviews for Drug Development

By Basheer A N

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Sep 22, 2021

good

By Sohel S

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Nov 10, 2020

good

By Dr M

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Sep 16, 2020

nice

By DIVYA S K

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Sep 15, 2020

Nice

By Anaswar U

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Sep 12, 2020

Nice

By Hrithikroshan

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Sep 10, 2020

Good

By GLORIYA V

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Aug 24, 2020

Good

By Uma M K

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Jun 20, 2020

Good

By Dhobi N

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Jun 10, 2020

Good

By sagiraju j s

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Jun 10, 2020

good

By yatam s r t

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Jun 8, 2020

good

By MASHETTY V

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May 19, 2020

Good

By sowjanya g

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Mar 4, 2019

good

By Mohammad j s

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Sep 23, 2017

good

By Timo Q

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Nov 6, 2024

top

By josephmary

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Jun 18, 2020

yes

By K V S R

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May 24, 2020

yes

By 名宏 鄭

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Aug 15, 2024

讚

By Jayashree

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Jul 23, 2023

G

By Zahid w

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Jun 2, 2023

g

By Murugadhs P

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Dec 7, 2022

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By Nwando O

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Feb 9, 2020

E

By Sailaja B

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Jul 10, 2019

N

By Alan Q

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May 17, 2018

E

By Arman A

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May 8, 2020

The course content is very good and the lecturers are highly knowledgeable in their fields. However, this course is a recording from a meeting (or conference) which is a bit distracting. People asking questions and two of the female lecturers were kind of laughing / joking a lot during this serious course. Also the one who was telling about FDA (in week one) was kind of saying "Oh, I don't know that.. I am not gonna talk about that.. You should have known.." This is a course and that's not I want hear from the lecturer. I felt that this meeting was not recorded for Coursera. It seems like someone said "Oh, we have the recording of this meeting and why not sell it on Coursera?". That's why I gave 4 stars.