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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

4.6
305件の評価
53件のレビュー

コースについて

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....

人気のレビュー

HG

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.

MR

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.

フィルター:

医薬品開発: 1 - 25 / 58 レビュー

by Miriam C

May 08, 2019

Seems to be based on lectures and data available at the time of 2013, so this course is getting a little bit dated now in 2019. Interesting and informative none the less.

by shaurya d b

Jan 23, 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

by Sailaja B

Jul 10, 2019

N

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.

by Akshay S S

Jul 02, 2019

This course is really helpful.

by Akshay T

Jun 23, 2019

good course

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 Sindy

Jun 16, 2019

Great course for learning the basics of the drug development process from clinical trials to filling marketing and post-marketing commitments. Great place to start!

by Tonia T

May 20, 2019

Well organized and relevant.

by Mrs. J P

May 10, 2019

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

by Alex

Apr 26, 2019

A very interesting lecture on drug development stages.

by vinay y

Apr 24, 2019

very good

by Teresa O

Mar 14, 2019

One of the best courses I ever took. Very informative.

by Arshad s

Mar 10, 2019

it is good to learn about new things in a different way

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.

by sowjanya g

Mar 04, 2019

good

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 JARUGUMALLI S S K C

Mar 03, 2019

Great...!

by Jan B

Feb 26, 2019

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

by Benoit E

Feb 21, 2019

A lot too much bla bla on the Phase iv part

by Vaibhav T

Feb 01, 2019

The concepts were concisely explained but the prerequisites from Drug Discovery helped a lot. The lectures were very informative and engaging.

by Courtney Z

Jan 29, 2019

I would recommend this course to anyone curious about the pharmaceutical industry to better understand the process of drug development from start to finish.

by James D

Jan 15, 2019

Great course, but some of the information is becoming outdated due to the course being from 2013

by Philip R

Dec 02, 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

by Adrián P F

Nov 12, 2018

The course is very informative, specially for people with no experience nor specialized formation in Clinical Trials. However, it is not very detailed nor demanding, so I doubt about its usefulness for someone with previous university formation in clinical research field.