Chevron Left
Back to Drug Development

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

4.7
stars
2,332 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

HG

Oct 15, 2018

Very well done and informative. I truly appreciate the Drug process in entirety being broken down into sections that are easy to comprehend. It is obvious the speakers were chosen for their knowledge.

KR

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!

Filter by:

451 - 466 of 466 Reviews for Drug Development

By DR. A G

•

Sep 5, 2020

good

By Pratiksha

•

Jun 2, 2020

n

i

c

e

By Dale G Y

•

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

•

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

•

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.

By Nayanika P

•

Jan 8, 2022

Okayish. I wouldn't recommend this. If you're really passionate about Drug Development and it's clinical aspects, try and find better courses.

By Alejandro g

•

May 28, 2020

The course was not structured as an online course. the slides were quite boring and some of the speakers were not enthusiastic

By Deleted A

•

Sep 14, 2022

Outdated series of classes that offer no real learning opportunities.

By Arash Y

•

Mar 3, 2018

Presentation slides and sound quality is at its lowest.

By Maria B

•

Mar 18, 2020

The course is not prepared for online course

By Benoit E

•

Feb 21, 2019

A lot too much bla bla on the Phase iv part

By Michael M

•

Sep 9, 2020

I only looked at the slides, as I wanted to confirm, what I read in some of the reviews. A standard issue on Coursera is, that material is not maintained and updated. I have worked in the pharmaceutical industry for more than 15 years now and everything is constantly evolving. The world of 2013 is not the world of 2020 and course material should e updated regularly.

By Ananya S

•

Jul 13, 2020

The data shown in the lecture and even the lecture itself is dated back to 2012. Kindly upload an updated lecture with new rules, recent data, recent examples. It would be of great help.

By Soheil R

•

Sep 11, 2023

Very bad, with useless material and lot of LOUGH in lecture specially in week 3

By 19BBT051-SHARVAISH D R B B

•

Sep 19, 2020

Nice very important

By Ramani D

•

May 24, 2020

Thank u so much