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医薬品開発 に戻る

カリフォルニア大学サンディエゴ校 による 医薬品開発 の受講者のレビューおよびフィードバック



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....



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.


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.


医薬品開発: 76 - 100 / 105 レビュー

by Ashwini K

Jul 17, 2017

Course materials are useful, lectures are very easy to understand, some of the video / sound editing is a bit unclear, since you can't see the presenter talk when the slides are being shown. Overall, a great intro to drug development.

by Amjad N

Mar 04, 2019

Overall, I liked this course. There are some improvements I would suggest: > list online resources more clearly > define acronyms and provide better definitions > quizzes need to be longer and slightly more challenging

by Subramanian K

Sep 03, 2017

The drug labeling seminar was not very informative. Both the presenters seemed to be wanting to go one-up on the other with their respective experiences. The entire session was too casual to be labeled as a lecture.

by Elena B

Apr 21, 2018

I would like to see more updated information (i.e. more information on biologicals), current presentation is a bit old (from 2008-2010?)

But it provides good general overview of the clinical development process.

by Hussein S

Nov 14, 2017

Provides a good overview on drug development phases and challenges. Some lecturers are from the industry which gives a practical feeling to the whole process.

by Muhamed S E

Aug 13, 2017

Great Course , although i had some hardships understanding some parts and i had to search it online on my own ,, but overall i would recommend it !


Sep 28, 2019

i think you should put the speaker talking videos also in the lec not only the slides this will give more intent to complete the course faster

by Álvaro S V

Mar 07, 2019

This course gives a wide overview about clinical trials and all the process needed to launch a new drug. I really enjoyed it.


Jul 30, 2019

Very easy to follow, fun, informal. Downside: speakers often talk in incomplete sentences, use inaudible terms.

by Nana F

Jun 19, 2019

Very informative and useful course. Thank you very much to everyone who helped this work come to light

by James D

Jan 15, 2019

Great course, but some of the information is becoming outdated due to the course being from 2013

by Jan B

Feb 26, 2019

An interesting introduction. It is more of an overview than an actual course. Would do again.

by Nadia C

Jan 30, 2020

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

by Yury K

Dec 02, 2019

Need to update the lectures to reflect rapidly changing regulatory issues

by Hiep X N

Aug 05, 2017

Informative course, instructors have a great deal of industry experiences

by Matthew K

Aug 03, 2017

Good primer on Drug Development albeit very high level.

by Alex

Apr 26, 2019

A very interesting lecture on drug development stages.

by Pao-Sheng C

Mar 02, 2017

Brilliant framework and well designed structure

by Muhammed T k

Sep 16, 2017

thanks ,it was interested

by Janet T

Oct 17, 2019

A great overview.

by Nilanjan P

Nov 30, 2019

excellent course

by Eliza V

Jul 16, 2017

The overall material was good. However, the course was not structured as an online course, rather an online posting of in class lectures. This made it difficult to hear the questions of the students as the questions were not repeated by the lecturer and therefore we received an answer to a question we didn't hear. Also, because of the lecture nature, a lot of information was missing from the slides as it was spoken information.

by Matthew L

Jan 06, 2020

Week 3 lectures were not as in-depth as hoped and filled with too many personal anecdotes for the time allowed. Much more could have been said if these had been skipped.

by Nikolai W

Sep 25, 2019

The name of the course should be something a la 'Clincal trials and drug admistration agencies'. It is not the development of a drug.

by Krithika S K N

Sep 02, 2019

Was informative. The lectures could have been more structured and slides more detailed.