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

4.7
stars
2,402 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

PR

Dec 1, 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

SB

Jan 22, 2019

this course is really very informative especially for those who are new to this field and even those who are experienced. I highly recommend to attend this great program

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101 - 125 of 478 Reviews for Drug Development

By Vikas K P

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Sep 27, 2020

It was a good experience. Learned about drug development process step by step . it was just amazing.

By Ravi K R J

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May 12, 2020

very useful for pharma regulatory graduates and professionals, thank you to coursera team...great job

By NARAYANA M G

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May 23, 2020

I learned s many new things from this course. Thanks to every presenter, they are well experienced

By Gabriel R

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Oct 24, 2019

an excellent course for those who want to understand better the whole process of Drug development.

By Anush G

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Oct 16, 2024

it was completely in detail class, was thrilled to solve the quiz questions, thank you sir/madam.

By MD R A

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Apr 29, 2020

This course is very good. A person from the pharmacy field gets to learn a lot from this course.

By aditya k

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Aug 4, 2020

it was very helpful in understanding the ways pharma companies manage to get their products out.

By Diana L

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May 22, 2020

Good course. But should be more updated information, if all the same regulation is still valid..

By Geeta M K

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Aug 13, 2020

This course is very interesting and also it is useful to us in ur upcoming future 💯 thank you!

By Jonas D G

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Jul 1, 2020

I really like the teachers and the Quiz. I hope this course will help me landing my next job!

By PAOLLA S G

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Mar 11, 2020

Super interessante!! Me ajudou muito a entender sobre novos medicamentos e suas legislações!!

By Jony M

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Mar 21, 2020

I have found this course good in terms of the content and lectures given by the instructors.

By Jhon L M

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Jun 9, 2021

a lot of interesting information. Also very glad to hear directly from the practitioner.

By Dilip P C

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Apr 2, 2022

good and information gaining courese and very usefull for the student like me and all .

By DASARI S

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Jul 25, 2020

This course is very useful for forthcoming generations who wants to do research field.

By saijyotheswar a

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May 31, 2020

very a good approach for the online courses and can learn the things outside the limit

By Jahnavi P

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May 10, 2019

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

By Kannikar T

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Nov 5, 2024

Refreshing my memories and adding some extra knowledge along with the certifications

By Faisal N K

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Sep 25, 2019

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

By Abi B

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Jul 17, 2023

This was a brilliant course!

Thank you for making this course available on Coursera.

By Vinit S

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Jan 8, 2021

Excellent course with detail discussion on clinical trial design at various phases.

By Gaanappriya M

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May 12, 2020

iNTERESTING COURSE WITH EXCELLENT MATERIALS. A GREAT READ AND A FABULOUS EXPERIENCE!

By Ibis A M

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Feb 8, 2017

Great course, great lectures and interesting subject. Learned a lot in a short time.

By Sivakumar S

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Sep 2, 2020

Got an understanding of what is actually going on in the pharmaceutical industries.

By Abdul B

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Mar 13, 2024

Learned a lot, and this course has broadened my perspective on drug development.