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Bewertung und Feedback des Lernenden für Medikamentenentwicklung von University of California San Diego

1,957 Bewertungen
401 Bewertungen

Über den Kurs

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 (, Drug Development and 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....



24. Mai 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.\n\nThank you!


15. Okt. 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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326 - 350 von 401 Bewertungen für Medikamentenentwicklung

von Nadia C

30. Jan. 2020

some of the things was a little bit old - But i liked the content and the concepts

von Aderbal A

18. Apr. 2021

the course is good, but classes are old and outdated. Many classes are lectures.

von Yury K

2. Dez. 2019

Need to update the lectures to reflect rapidly changing regulatory issues

von Hiep X N

5. Aug. 2017

Informative course, instructors have a great deal of industry experiences

von abbas a

28. Mai 2020

It was very helpful to me,and I learned much better in this quarantine.

von Vindhya S R

6. Nov. 2020

It was indeed a great course. It was quite informative. Thank you!

von Morongwa

26. März 2020

Thoroughly enjoyed this. Could do with an updating of materials.

von Ugbosu F O

27. Mai 2021

It was at first looking boring but i ended up having a nice time


10. Sep. 2020

Me ha parecido muy interesante el mundo farmacéutico-industrial.

von shubham b

21. Sep. 2021

i have learned all the phases in brief thanks to coursera .

von Matthew K

3. Aug. 2017

Good primer on Drug Development albeit very high level.

von Avishek S

27. Aug. 2020

It can be more arranged and in detail.

but pretty good.

von Alex

25. Apr. 2019

A very interesting lecture on drug development stages.

von Mahesh W

21. Feb. 2022

I know deeply the details of phases clinical trials


5. Nov. 2020

An amazing way to learn drug development studies.

von Pao-Sheng C

2. März 2017

Brilliant framework and well designed structure

von Rekhakumari C

17. Aug. 2020



21. Juni 2020

Very informative and illustrative course

von Hesham E

26. Mai 2020

Wonderful journey in drug lifecycle.


14. Mai 2021

It was very informational,



23. Sep. 2021

very informative wrt formal aspect

von Rajan D

2. Mai 2022

t​rials and their usage is great.


28. Juli 2020

need more elaborated lectures

von Kurre B

5. Juli 2020

Nice and very well explained


27. Mai 2020

This course was very useful