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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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276 - 300 of 485 Reviews for Drug Development

By Rafael V

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Jul 13, 2020

Great Course

By monika k

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Aug 3, 2022

very useful

By parikshith s d

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Sep 1, 2020

magnifisant

By MUHAMMAD B

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May 11, 2020

Its awesome

By Akshay T

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Jun 23, 2019

good course

By Sudarahan S K

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Oct 11, 2020

Its 5 star

By Sourav M

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Sep 21, 2018

Thank you.

By Mohamed S T A A

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Sep 5, 2017

Excellent.

By CS M L

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Nov 5, 2020

excellent

By Alessandro G

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Aug 31, 2020

excellent

By Abhishek M J

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Aug 2, 2020

Excellent

By srinivas r b

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Jul 25, 2020

Excellent

By botta a d

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Jul 24, 2020

Very good

By PRIYA P

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Jul 2, 2020

excellent

By Akhil N A

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May 31, 2020

Excellent

By vinay y

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Apr 24, 2019

very good

By krishna c

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Mar 3, 2019

Great...!

By MOHSIN A K

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Dec 28, 2023

worth it

By Pereverzeva A

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Mar 31, 2020

Отлично!

By Abdulvohid P

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Aug 19, 2024

perfect

By Stines J

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Aug 19, 2021

helpful

By Dr. N F

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May 12, 2020

awesome

By DR S D

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Jan 8, 2022

useful

By E01203139-SHERLIN S T B B

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Sep 26, 2020

Useful