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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: 51 - 75 / 105 レビュー

by Tahir H

Dec 23, 2019

It was a good experience

by Chintan B

Aug 26, 2019

Very Informative course

by Magdoline N N

Oct 09, 2019

Very useful course

by aula s

Jan 06, 2020

Thank you so much

by Yuvashini E

Jan 10, 2020

was very helpful

by Gozde I A

Sep 02, 2019

Very informative


Jul 25, 2018


by Akshay T

Jun 23, 2019

good course

by Sourav M

Sep 21, 2018

Thank you.


Sep 05, 2017


by Rashel A

Jan 06, 2020


by Alessandro G

Oct 06, 2019


by vinay y

Apr 24, 2019

very good


Mar 03, 2019


by sowjanya g

Mar 04, 2019


by Mohammad j s

Sep 23, 2017


by Nwando O

Feb 09, 2020


by Sailaja B

Jul 10, 2019


by Alan Q

May 17, 2018


by Valery T

May 27, 2018

Thisa course was very intersting to learn more about new drug application 2 years before applying to the FDA, the week 2 and 3 clinical trials and regulatory aspects were very interesting. The format of assessment can be like content of 3/4 page and then the individual selects an option as to what to do to rectify the information. That is a more efficient process to creatively think and do the regulations job in a real world scenario. I had no hesitation in doing this course and would do it again. Very useful for my background of medical technician and analytical chemistry degrees.

by miranda w

Feb 18, 2020

I think the Course name should be changed - Drug Development - Clinical Trials through the phases.

It is super useful for people wanting to learn about clinical trials, it is mostly about clinical trials BUT the name of the course doesn't convey this, so a propospective employer in clinical trials wont care about this course because the name isnt informative enough about what you taught

by Vanja T F

Feb 22, 2018

Very good talks and presentations, amazing speakers, lots of interesting information, very valuable course.

But OLD - the course needs major renewal, with new data and new talks. Same for power point presentations: most of them are totally useless, hard to understand and follow and just do not look nice. Please prepare better presentations for the next course.

by Brendan D

Oct 15, 2017

Overall the content was relevant to drug development and presented in an organized manner. The presenters seemed to have a wealth of experience in development. This was my first time using Coursera and I enjoyed being able to pick up where I left off. I was disappointed with the course transcriptions as there were many inaccuracies.

by Momchil N

Feb 16, 2020

I truly enjoyed the lecture content and am thankful for the course.

For me, the lectures in week 3 need to be updated and changed. I was confused by the two lecturers taking on each other. I found the lecture material of the others speakers better organized

by George W

Jul 05, 2019

This is an informative course on clinical trial development and regulatory considerations of drug development. However, I wish the course content is more updated and organized. The lecture videos are the just recordings from their classes in 2013.