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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

DL

Aug 18, 2020

Thank you the opportunity to learn this wonderful course. Its really a good course for those who are interested in drugs and the development procedures and protocol.

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151 - 175 of 478 Reviews for Drug Development

By Sahil K

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Aug 14, 2020

Very helpful in knowledge building and good quality content.

By SNEHA V

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Aug 8, 2020

Its Completely Useful for students!! Keep going. Thank you!!

By Ansumita B

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May 5, 2020

I liked the course it was awesome learning from this coursea

By David L

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Oct 29, 2019

Could do with an update. It's 6 years old, much has changed.

By Maria T

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Mar 29, 2022

Very informative on clinical trials and industrial issues.

By Sarah F

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Oct 14, 2024

Excellent! Very easy to follow, loved the use of examples.

By Reem M A R

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Jun 28, 2020

Great knowledge for steps of new drugs registration in FDA

By Yashwantsinh J

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Jun 18, 2020

Good learning prospectives and very interesting sessions.

By Prateek K

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Oct 1, 2021

immersive and insightful across the pharma value chain.

By CHANCHALA A

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Jun 27, 2020

very useful to our knowledge happy to choose this course

By KONKEPUDI G M

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Jun 15, 2020

VERY HELPFUL FOR THE STUDENTS IN PHARMACEUTICAL SCIENCES

By H C

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Aug 6, 2017

I could understand about the process of drug development

By Mohammed M H C

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Apr 18, 2020

Excellent course and enriched materials with clear view

By t. O

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Mar 14, 2019

One of the best courses I ever took. Very informative.

By Arshad s

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Mar 10, 2019

it is good to learn about new things in a different way

By Ahmed

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Sep 21, 2020

This has been a hard time but it was worth it . thanks

By DEVIS M M D P

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Sep 17, 2020

It teaches the kind of hidden part of drug development

By Nancy Z

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Feb 1, 2021

Perfect balance of scientific and business knowledge.

By Nallipogu S T

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Sep 29, 2020

Is this a good platform to gain knowledge in COURSERA

By Talissa C M D B

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Jul 28, 2020

Muito bom, apenas não consegui acessar o certificado

By anubhav t

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Sep 12, 2021

loved it... increased my understsanding of industry

By Alvena N

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Mar 29, 2025

I loved this course, it was extremely interesting

By Bekezela B K

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Feb 14, 2023

Insightful course, with knowledgeable instructors

By Yujiao M

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Oct 7, 2022

Thanks to the lecturers for sharing experience!!

By KEERTHIKA s

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Sep 17, 2020

Very interesting course. I am so happy. Thank you