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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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376 - 400 of 466 Reviews for Drug Development

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 21, 2021

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

By Rosilin S A f

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Oct 31, 2024

Its, becoming more interesting and interesting to learn.

By Matthew K

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Aug 3, 2017

Good primer on Drug Development albeit very high level.

By Avishek S

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Aug 27, 2020

It can be more arranged and in detail.

but pretty good.

By Alex

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Apr 25, 2019

A very interesting lecture on drug development stages.

By Mahesh W

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Feb 21, 2022

I know deeply the details of phases clinical trials

By Deepak R

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Jul 15, 2023

Week 2 seems to be more technical than the others.

By ABHISHEK S

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Nov 5, 2020

An amazing way to learn drug development studies.

By Paul C

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Mar 2, 2017

Brilliant framework and well designed structure

By Sifat U

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Nov 8, 2022

This course was really tough but I enjoyed it

By Rekhakumari C

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Aug 17, 2020

INFORMATIVE & GOO EXPERIENCE . THANKYOU..

By VIHAN S

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Jun 21, 2020

Very informative and illustrative course

By Hesham E

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May 26, 2020

Wonderful journey in drug lifecycle.

By Vineet A

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May 14, 2021

It was very informational,

THANK YOU

By ABHIRAM P G

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Sep 23, 2021

very informative wrt formal aspect

By Rajan D

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May 2, 2022

trials and their usage is great.