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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

4.7
2,000 个评分

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

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.

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.

Thank you!

筛选依据:

226 - 药物开发 的 250 个评论(共 405 个)

创建者 Leah F

Apr 9, 2020

so interesting

创建者 Daniela P Q C

Mar 9, 2022

Very complete

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 monika k

Aug 3, 2022

very useful

创建者 parikshith s d

Aug 31, 2020

magnifisant

创建者 MUHAMMAD B

May 11, 2020

Its awesome

创建者 Akshay T

Jun 22, 2019

good course

创建者 Sudarahan S K

Oct 10, 2020

Its 5 star

创建者 Sourav M

Sep 21, 2018

Thank you.

创建者 Mohamed S T

Sep 5, 2017

Excellent.

创建者 CS M L

Nov 4, 2020

excellent

创建者 Alessandro G

Aug 30, 2020

excellent

创建者 Abhishek M J

Aug 1, 2020

Excellent

创建者 srinivas r b

Jul 25, 2020

Excellent

创建者 botta a d

Jul 23, 2020

Very good

创建者 PRIYA P

Jul 2, 2020

excellent

创建者 Akhil N A

May 30, 2020

Excellent

创建者 Rasel A

Jan 6, 2020

Excellent

创建者 vinay y

Apr 24, 2019

very good