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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
990件の評価
233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

KR

May 25, 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!

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.

フィルター:

医薬品開発: 76 - 100 / 233 レビュー

by Rujuta M

May 31, 2020

I am immensely thankful to courser for providing this platform to us

by BODDEPALLI A S

Jun 02, 2020

very useful for those who are worlking in research and development

by kayde z

Mar 14, 2020

very helpful. useful information about the pharmaceutical industry.

by Baddela S

Apr 12, 2020

Good course and refreshment on learning with a day to day examples

by sai c A

May 23, 2020

Its a wonderful course, its very useful for new drug application

by Felipe R F

Jan 19, 2020

Very good content. Could go more in depth of the studies designs

by Rohan M

Apr 23, 2020

very informative and good teachers.....gained some knowledge...

by Imani A

Feb 10, 2020

I truly enjoyed taking this course. It was beyond a refresher!

by Penugonda V L D S S

May 28, 2020

very useful and informative....thanks a lot to the instructors

by Ansumita B

May 05, 2020

I liked the course it was awesome learning from this coursea

by David L

Oct 29, 2019

Could do with an update. It's 6 years old, much has changed.

by Reem M A R

Jun 28, 2020

Great knowledge for steps of new drugs registration in FDA

by Yashwantsinh J

Jun 18, 2020

Good learning prospectives and very interesting sessions.

by CHANCHALA A

Jun 27, 2020

very useful to our knowledge happy to choose this course

by KONKEPUDI G M

Jun 15, 2020

VERY HELPFUL FOR THE STUDENTS IN PHARMACEUTICAL SCIENCES

by CHO H

Aug 06, 2017

I could understand about the process of drug development

by Mohammed M H C

Apr 18, 2020

Excellent course and enriched materials with clear view

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 Pathak K J

May 29, 2020

Good for learning and thank you for your support

by Mrs. P S A

May 14, 2020

I loved to learning the drug development course.

by Samiya K

Jan 26, 2020

this course prooved to be really very beneficial

by Sneha B G

May 18, 2020

Best Course to Learn Drug development process.

by Shivam d

May 01, 2020

I found it more knowledge... Tq so much for it

by Dr H J

May 18, 2020

It was a NICE EXPERIENCE AND LOTS OF LEARNING