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

4.7
stars
2,402 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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251 - 275 of 478 Reviews for Drug Development

By ZADE R

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Jul 10, 2025

it is benificial

By Sanghamitra M

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Mar 13, 2023

Very informative

By Mahmoud A

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Dec 3, 2021

Drug Development

By Sanchit V

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May 17, 2020

excellent course

By Yuvashini E

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Jan 10, 2020

was very helpful

By Gozde I A

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Sep 2, 2019

Very informative

By SAMEER A

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Jul 25, 2018

EXCELLENT COURSE

By Anthony E J T

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Jul 26, 2020

Muy informativo

By julio r l

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May 5, 2020

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By Shikha K

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Jun 7, 2020

great learning

By Leah F

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Apr 9, 2020

so interesting

By Umair R

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Sep 13, 2022

very helpful

By Daniela P Q C

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Mar 9, 2022

Very complete

By Andrey K

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Aug 9, 2021

Great course!

By Mehedi H R 1

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Aug 29, 2020

Great course.

By S.Nandha k

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Jun 12, 2020

Useful course

By Anirudha D

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Jun 28, 2021

Very helpful

By Jonathan M

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Dec 1, 2020

Excellent!!!

By MRS. S

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Aug 25, 2020

Very helpful

By Rafael V

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Jul 12, 2020

Great Course

By monika k

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Aug 3, 2022

very useful

By parikshith s d

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Aug 31, 2020

magnifisant

By MUHAMMAD B

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May 11, 2020

Its awesome

By Akshay T

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Jun 22, 2019

good course

By Sudarahan S K

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Oct 10, 2020

Its 5 star