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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!

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126 - 150 of 466 Reviews for Drug Development

By Nhật T N L

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May 1, 2017

It's amazing experience. I had the opportunity to get access to new knowledge

By Rutuja T

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Jun 8, 2020

it was a great course i aquired so much knowledge about the clinical trails.

By Md. A S

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May 23, 2020

Really awesome course. Anyone can get a better idea about drug development.

By Dr.M N

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Jul 7, 2020

Very informative course for learning different stages of drug development

By Ana S G C

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May 30, 2021

Very educatinal and eye openning in regards to pharmaceutical processes

By Brittany N A

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Aug 21, 2019

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

By prathamesh k

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Jul 24, 2020

Touched the More Technical aspects in core pharmaceutical Development.

By Tharini C

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Jun 20, 2020

Got a thorough basic idea on all aspects involved in drug development.

By Amit K S

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Nov 5, 2023

This course is really good to know better about the drug development.

By Christina A

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Oct 18, 2020

Excellent course. Easy to follow and comprehend a very complex topic.

By saleem a

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May 18, 2020

I was able to listen to the course while commuting and learned a lot.

By Rujuta M

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May 31, 2020

I am immensely thankful to courser for providing this platform to us

By BODDEPALLI A S

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Jun 2, 2020

very useful for those who are worlking in research and development

By kayde z

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Mar 14, 2020

very helpful. useful information about the pharmaceutical industry.

By Srikanth B

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Apr 11, 2020

Good course and refreshment on learning with a day to day examples

By MARIA C A P

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Sep 10, 2020

Muy buen material académico y ejemplos por partes de los docentes

By Abburu S

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May 23, 2020

Its a wonderful course, its very useful for new drug application

By Felipe R F

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Jan 19, 2020

Very good content. Could go more in depth of the studies designs

By Prachiti C

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Nov 7, 2024

its a good course but needs an update. content is a decade old.

By Imani

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Jul 31, 2020

I truly enjoyed taking this course. It was beyond a refresher!

By Rohan M

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Apr 23, 2020

very informative and good teachers.....gained some knowledge...

By Penugonda V L D S S

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May 28, 2020

very useful and informative....thanks a lot to the instructors

By Chinmay P

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Jul 29, 2020

Easy to learn with goof knowledge and just perfect time span.

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!!