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

4.6
428 ratings
85 reviews

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 16, 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.

MR

Jul 19, 2018

Information in the course is very practical. I come from basic biology background and now with this course I gained some real insights about how the clinical trails happen.

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26 - 50 of 84 Reviews for Drug Development

By Philip R

Dec 02, 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

By Mrs. J P

May 10, 2019

Was a very informative course, gave me an overview of entire drug development process.

By Sindy

Jun 16, 2019

Great course for learning the basics of the drug development process from clinical trials to filling marketing and post-marketing commitments. Great place to start!

By Akshay T

Jun 23, 2019

good course

By Akshay S S

Jul 02, 2019

This course is really helpful.

By Sailaja B

Jul 10, 2019

N

By Tonia T

May 20, 2019

Well organized and relevant.

By SAMUEL E R

Aug 04, 2019

Esta genial para aprender el desarrollo de fármacos, es eficaz y puedes utilizar varios archivos para completar toda la información

By Rosa E H E

Aug 07, 2019

It's a great course to introduce you to many aspects of Drug Development. From the mouth of experts with many years of experience on the field. They also provide you with the slides so you can keep the training material.

By Methun P

Aug 10, 2019

awesome course.i enjoyed.

By Abdulkader

Aug 11, 2019

Great course, well experienced teachers

By vinay y

Apr 24, 2019

very good

By Brittany N A

Aug 21, 2019

I truly enjoyed this course. I learned some valuable information in the

By dr a a h

Aug 20, 2019

I enjoyed the course very much.....

By Shyam S P

Sep 14, 2019

It was really a great self pace learning course of drug discovery.I learnt so many different terminologies and concepts which were not covered in my academic syllabus.Thank you Cousera for providing us such a great platform and i am also thankful for Financial assistance.

By Chintan B

Aug 26, 2019

Very Informative course

By Gozde I A

Sep 02, 2019

Very informative

By Radwa A M A E

Sep 21, 2019

Enjoyed the course and significantly helped me to understand a number of pharmaceuticals regulatory issues, a discipline not greatly covered via online courses. Thank You University of California San Diego, Thank you Coursera :)

Education for Everyone :)

By Moataz A A A

Sep 29, 2019

excellent one and very useful

By faryal f

Oct 01, 2019

it was very informative and i loved doing it

By Alessandro G

Oct 06, 2019

excellent

By Magdoline N N

Oct 09, 2019

Very useful course

By Nityasri V

Sep 26, 2019

Thank you very much for covering all Phases of clinical trial. Very useful and informative. Thank you for providing me with the financial aid to complete this course.

By Faisal N K

Sep 25, 2019

Highly recommended, very insightful and gives a broad overview of Drug development.

By Mohamed A

Oct 15, 2019

It was a great course teaching me many things about drug development. cannot wait to go to the third course a Drug commercialization