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

4.7
stars
2,426 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

MT

Jun 9, 2020

Clinical trial are most important part of pharma sector for drug development and development of a molecule It's important to all of us whose involved in research and development Thank you!!!

HD

Aug 3, 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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401 - 425 of 485 Reviews for Drug Development

By Matthew K

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Aug 4, 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 26, 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 16, 2023

Week 2 seems to be more technical than the others.

By ABHISHEK S

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Nov 6, 2020

An amazing way to learn drug development studies.

By Paul C

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Mar 3, 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 27, 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 24, 2021

very informative wrt formal aspect

By Rajan D

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May 2, 2022

trials and their usage is great.

By ABHIJEET N

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Jul 29, 2020

need more elaborated lectures

By Kurre B

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Jul 6, 2020

Nice and very well explained

By MUSAIB Z

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May 28, 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 23, 2020

Very informative course.

By Himanshi

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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 18, 2019

A great overview.

By KAVITHA C 2

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Feb 11, 2024

easy and awesome