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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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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.

Thank 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.

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251 - 药物开发 的 275 个评论(共 405 个)

创建者 JARUGUMALLI S S K C

Mar 3, 2019

Great...!

创建者 Anna P

Mar 30, 2020

Отлично!

创建者 stines j

Aug 18, 2021

helpful

创建者 Dr. N F

May 12, 2020

awesome

创建者 DR S D

Jan 8, 2022

useful

创建者 E01203139-SHERLIN S T B B

Sep 26, 2020

Useful

创建者 Sowmiya N

Jun 10, 2020

cheers

创建者 BAALOUDJ O

Jun 2, 2020

THANKS

创建者 DEVENDRA B

Jan 4, 2022

​good

创建者 shekinah g

Mar 23, 2021

Thank

创建者 Basheer A N

Sep 22, 2021

good

创建者 Sohel S

Nov 10, 2020

good

创建者 Dr M

Sep 16, 2020

nice

创建者 DIVYA S K

Sep 15, 2020

Nice

创建者 19BBT006-ANASWAR S B B B

Sep 12, 2020

Nice

创建者 Hrithikroshan

Sep 10, 2020

Good

创建者 GLORIYA V

Aug 24, 2020

Good

创建者 Uma M K

Jun 20, 2020

Good

创建者 Dhobi N

Jun 10, 2020

Good

创建者 sagiraju j s

Jun 10, 2020

good

创建者 yatam s r t

Jun 8, 2020

good

创建者 MASHETTY V

May 19, 2020

Good

创建者 sowjanya g

Mar 4, 2019

good

创建者 Mohammad j s

Sep 23, 2017

good

创建者 josephmary

Jun 18, 2020

yes