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

4.7
stars
2,231 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

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!

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.

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51 - 75 of 442 Reviews for Drug Development

By humera k

Aug 1, 2020

The excellent course for the complete study for drug development ,its trial ,marketing and learning all aspects about the study of drugs before coming to the market

By Sindy O P

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 Ohakwe N G

Sep 17, 2020

Amazing. The Lecturers made this topic very interesting and informative, gave very good examples and analogies to help understanding easier. Thanks, UC San Diego

By Courtney Z

Jan 29, 2019

I would recommend this course to anyone curious about the pharmaceutical industry to better understand the process of drug development from start to finish.

By vidya m

Jul 28, 2021

The speakers and the course content are very good. it gave me a good understanding of the different trial phases and the challenges in each one of them.

By Eva K

Oct 24, 2019

Thank you, this course gave me basic understanding of drug development and clinical trials and I hope, it will help me to find new job position.

By A U

Mar 28, 2021

Lots of valuable information - like one of the instructor said its not even scratching the surface. This course is showing where the surface is

By radha g

May 20, 2020

It has been of a great use. To those who are dealing with pharmaceuticals, this course is helpful. The lectures are explained in a lucid manner

By Antonio F

Aug 12, 2020

This course was fantastic! I must say sometimes important points were not on slides, so it would be beneficial to watch videos more than once!

By Vaibhav T

Feb 1, 2019

The concepts were concisely explained but the prerequisites from Drug Discovery helped a lot. The lectures were very informative and engaging.

By shruti k

May 20, 2021

learning from the case studies and experience of instructors is the best part of this course. You really learn some beyond textbook knowledge

By Karonaa R

Apr 21, 2020

Good course, which can be easily understands to all. Thank you who are all taken such a useful and very informative sessions. Good luck all.

By debaprasad g

Jun 1, 2020

Last lectures were too much discussions rather than lecture, please include some informations those were told verbally but not in the ppts.

By chenyang j

Aug 3, 2020

very clearly illustrated the clinical trial from phase 1 to phase 4 and with border and depth thought of the present regulation by the FDA

By Malavika

Oct 18, 2020

Excellent course, well explained for a beginner and definitely would leave with further interest in studying something of similar nature.

By Arunima R

Jun 5, 2020

very helpfull insights to the clinical trials, high;y recommend to whoever has interest in drug development , commercialization and DRA

By Niyati J

Jul 9, 2020

It was an amazing course. I have learned a lot about drug development starting from IND filing to the drug actually coming to market.

By Harie V

Feb 17, 2020

I find the course to be extremely informative due to the fact that actual industrial people have handled the drug development course.

By anubhav k

Jul 2, 2020

It was a really good experience to learn about regulatory aspects of how FDA works and studies done various parts of clinical trials

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

By SAMUEL E R

Aug 4, 2019

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

By Christos S

Jun 11, 2021

I learned a lot and I'm interested in doing more research on a number of different topics in this course. Definitely worth while.

By Pankaj K D

May 6, 2020

such a great course where I found very important information. This course helps me to develop my knowledge about Drug Development

By Deepa P S

Sep 20, 2020

Really useful course in knowing all the Phases of Drug development. I loved each and every lecture slide along wit the quiz

By Swarnadeep B

May 13, 2020

Very good for a beginner as well for revising all basics of drug development, Thank you Coursera and UCsan Diego university