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学生对 加州大学圣地亚哥分校 提供的 药物开发 的评价和反馈

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1,839 个评分
386 条评论

课程概述

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....

热门审阅

KR
May 24, 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 15, 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.

筛选依据:

201 - 药物开发 的 225 个评论(共 384 个)

创建者 ankita p

Sep 17, 2021

informative course

创建者 Akilesh

Jun 13, 2020

Very useful course

创建者 Magdoline N N

Oct 9, 2019

Very useful course

创建者 Raghad K

Aug 20, 2021

v​ery informative

创建者 Rodney T

Mar 26, 2021

Very good course.

创建者 Sarah s

Nov 19, 2020

Veryy nice course

创建者 Melody F

Jul 19, 2020

Excellent course!

创建者 J P V

May 26, 2020

nice course .....

创建者 Aula

Jan 6, 2020

Thank you so much

创建者 Sanchit V

May 17, 2020

excellent course

创建者 Yuvashini E

Jan 10, 2020

was very helpful

创建者 Gozde I A

Sep 2, 2019

Very informative

创建者 SAMEER A

Jul 25, 2018

EXCELLENT COURSE

创建者 Anthony E J T

Jul 26, 2020

Muy informativo

创建者 julio r l

May 5, 2020

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创建者 Shikha K

Jun 7, 2020

great learning

创建者 Leah F

Apr 9, 2020

so interesting

创建者 Andrey K

Aug 9, 2021

Great course!

创建者 Mehedi H R 1

Aug 29, 2020

Great course.

创建者 S.Nandha k

Jun 12, 2020

Useful course

创建者 Anirudha D

Jun 28, 2021

Very helpful

创建者 Jonathan M

Dec 1, 2020

Excellent!!!

创建者 MRS. S

Aug 25, 2020

Very helpful

创建者 Rafael V

Jul 12, 2020

Great Course

创建者 parikshith s d

Aug 31, 2020

magnifisant