Name: Drug Development
Brand: University of California San Diego
Availability: OnlineOnly
Rating: 4.7 (474 reviews)

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

4.7

stars

2,391 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

Jan 17, 2021

I thought this course was done very well. The lectures were extremely informative and easy to follow. They connected very well with the audience. I would recommend this course to others...and I will.

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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451 - 475 of 481 Reviews for Drug Development

By Krithika S K N

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Sep 2, 2019

Was informative. The lectures could have been more structured and slides more detailed.

By Adrija C

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Nov 2, 2020

US- centric course. The content in week 3 was not well explained and felt rushed.

By Aneesh T G

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Aug 23, 2020

More emphasis on the filing and submissions and approvals need to be there

By Carolina S V

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Dec 27, 2017

Weeks 1 and 2 are great, but the classes of week 3 need more organization.

By Damien V

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Sep 17, 2018

good up to phase 2 (included). Phase 3 and after was less informative

By Michael A

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Feb 1, 2025

Too outdated; wish there was some new material (it's 2025)!

By Sean K

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Feb 21, 2022

Lot of outdated information and poor presentation slides

By Brian M

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Apr 25, 2021

It's from 2013. Good overview but time for an update.

By Miguel M V

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Aug 31, 2020

would like an specialization on this matter

By Budupula K

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Jun 19, 2021

I gained knowledge

By Sofia B J

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Sep 2, 2020

goooooood

By Aman b

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Sep 15, 2021

good

By DR. A G

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Sep 5, 2020

good

By Pratiksha

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Jun 2, 2020

By Dale G Y

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Aug 24, 2021

Had hoped to hear a better description of the types of trials and more about the Regulators' logic in deciding what trials a drug must have - PK for ANDA? BE for ANDA? P1 and P3 for 505B2? Does PK=P1? These topics are useful. Need to define these options and explain the reason for using them for different scenarios. That's part of what I expected from Drug Development.

The lecture style of second half was difficult. More structure, clear pronunciation, less random thoughts about unexplained topics.

By Mohamed T H

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Jul 18, 2020

Phase 1 was explained nicely. But phase 2 description was unclear with some diagrams with not much context and a lot of acronyms thrown around. Did not learn a lot about phase 3 either. The presentation slides were very busy like the previous course.

By Malamati V

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Oct 23, 2020

I felt like the lectures were not so organized as far as their material is concerned. I also found the overall course more "business-oriented" than actually educational.