Chevron Left
返回到 药物开发

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

4.6
740 个评分
167 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

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.

MR

Jul 19, 2018

Information in the course is very practical. I come from basic biology background and now with this course I gained some real insights about how the clinical trails happen.

筛选依据:

76 - 药物开发 的 100 个评论(共 171 个)

创建者 Shivam d

May 01, 2020

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

创建者 Dr H J

May 18, 2020

It was a NICE EXPERIENCE AND LOTS OF LEARNING

创建者 faryal f

Oct 01, 2019

it was very informative and i loved doing it

创建者 SYEDA K F

May 15, 2020

very nice effort by university of San Diego

创建者 Beatrice M

Feb 15, 2017

Great Class. We need more of these courses.

创建者 Matias G

May 14, 2020

Very good intrudction to all the trials

创建者 Abdulkader

Aug 11, 2019

Great course, well experienced teachers

创建者 dr a a h

Aug 20, 2019

I enjoyed the course very much.....

创建者 Lankadi D

May 24, 2020

Its an excellant course i loved it

创建者 Erica K T

Mar 27, 2020

Very informative, easy to follow

创建者 Akshay S S

Jul 02, 2019

This course is really helpful.

创建者 Moataz A A A

Sep 29, 2019

excellent one and very useful

创建者 Raji L M

Jan 15, 2020

Detail and an amazing course

创建者 Tonia T

May 20, 2019

Well organized and relevant.

创建者 Nanting N

May 11, 2020

I really enjoy this class!

创建者 prudhvi r

May 21, 2020

Easy way of understanding

创建者 Methun P

Aug 10, 2019

awesome course.i enjoyed.

创建者 Tahir H

Dec 23, 2019

It was a good experience

创建者 Chintan B

Aug 26, 2019

Very Informative course

创建者 Pratik P

Apr 22, 2020

Nc course it's useful

创建者 Magdoline N N

Oct 09, 2019

Very useful course

创建者 J P V

May 26, 2020

nice course .....

创建者 aula s

Jan 06, 2020

Thank you so much

创建者 Sanchit V

May 18, 2020

excellent course

创建者 Yuvashini E

Jan 10, 2020

was very helpful