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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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By Jayasri R

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Nov 8, 2024

good

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Nov 6, 2024

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Nov 4, 2024

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Nov 3, 2024

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Oct 27, 2024

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Sep 30, 2023

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Sep 22, 2021

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By Sohel S

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Nov 10, 2020

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By Dr M

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Sep 16, 2020

nice

By DIVYA S K

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Sep 15, 2020

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By Anaswar U

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Sep 12, 2020

Nice

By Hrithikroshan

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Sep 10, 2020

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Aug 24, 2020

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Jun 20, 2020

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Jun 10, 2020

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Jun 10, 2020

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Jun 8, 2020

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By MASHETTY V

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May 19, 2020

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By sowjanya g

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Mar 4, 2019

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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

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