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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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226 - 250 of 485 Reviews for Drug Development

By Roshani S P

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Sep 9, 2020

best course study material.

By Saras H T

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Aug 13, 2020

it was very fruitful course

By Gaurav b

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Jun 5, 2020

great and very informative

By Nanting N

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May 12, 2020

I really enjoy this class!

By Stefany M

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Oct 12, 2024

amei demais, excelente!!!

By Ewmi R

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Oct 9, 2020

A well structured course.

By prudhvi r

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May 21, 2020

Easy way of understanding

By Methun P

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Aug 11, 2019

awesome course.i enjoyed.

By Tahir H

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Dec 23, 2019

It was a good experience

By RANTHU A

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Jul 3, 2020

giving more information

By Israel V V

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Jun 22, 2020

I learned a lot, thanks

By Chintan B

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Aug 27, 2019

Very Informative course

By Jyoti B

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Jan 31, 2022

The course is ecellent

By Zanab M B M

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Aug 20, 2024

كانت رائعة ومفيدة جدا

By Pratik P

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Apr 22, 2020

Nc course it's useful

By RHIANE A C

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Oct 1, 2020

Knowledgeable course

By Gore A (

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Jul 21, 2023

Thank You So Much ,

By Choudhary S A

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Jan 6, 2022

eexcellent course

By ankita p

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Sep 17, 2021

informative course

By Akilesh

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Jun 13, 2020

Very useful course

By Magdoleen N

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Oct 10, 2019

Very useful course

By Ravi K M

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Aug 3, 2024

A good refresher.

By Raghad K

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Aug 21, 2021

very informative

By Rodney T

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Mar 27, 2021

Very good course.

By Sarah s

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Nov 19, 2020

Veryy nice course