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返回到 药物开发

學生對 加州大学圣地亚哥分校 提供的 药物开发 的評價和反饋

4.6
843 個評分
192 條評論

課程概述

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....

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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.

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101 - 药物开发 的 125 個評論(共 193 個)

創建者 Nanting N

May 11, 2020

I really enjoy this class!

創建者 prudhvi r

May 21, 2020

Easy way of understanding

創建者 Methun P

Aug 10, 2019

awesome course.i enjoyed.

創建者 Tahir H

Dec 23, 2019

It was a good experience

創建者 Chintan B

Aug 26, 2019

Very Informative course

創建者 Pratik P

Apr 22, 2020

Nc course it's useful

創建者 Magdoline N N

Oct 09, 2019

Very useful course

創建者 J P V

May 26, 2020

nice course .....

創建者 aula s

Jan 06, 2020

Thank you so much

創建者 Sanchit V

May 18, 2020

excellent course

創建者 Yuvashini E

Jan 10, 2020

was very helpful

創建者 Gozde I A

Sep 02, 2019

Very informative

創建者 SAMEER A

Jul 25, 2018

EXCELLENT COURSE

創建者 julio r l

May 06, 2020

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創建者 Leah F

Apr 09, 2020

so interesting

創建者 MUHAMMAD B

May 11, 2020

Its awesome

創建者 Akshay T

Jun 23, 2019

good course

創建者 Sourav M

Sep 21, 2018

Thank you.

創建者 MOHAMED S T

Sep 05, 2017

Excellent.

創建者 Akhil N A

May 30, 2020

Excellent

創建者 Rashel A

Jan 06, 2020

Excellent

創建者 Alessandro G

Oct 06, 2019

excellent

創建者 vinay y

Apr 24, 2019

very good

創建者 JARUGUMALLI S S K C

Mar 03, 2019

Great...!

創建者 Pereverzeva A

Mar 30, 2020

Отлично!