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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

4.6
990 个评分
233 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 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.

筛选依据:

51 - 药物开发 的 75 个评论(共 233 个)

创建者 Siddharth A

Jun 03, 2020

Really informative and nicely explained so that even beginners wouldn't have any issues understanding the topics.

创建者 Vivek H R

May 25, 2020

Quite impressive and Informational course for any individual hoping to advance in the pharmaceutical sector

创建者 Philip L

Nov 13, 2016

Excellent detailed course. Although US content. It is relevant since much development is done in the USA.

创建者 Afroj K

May 13, 2020

Its A good Opportunity to learn the drug development.

very well explained.

thank you for such opportunity.

创建者 Manish K

Apr 26, 2020

Excellent course taught be highly knowledgeable and experienced industry professionals and professors.

创建者 Ravi K R J

May 12, 2020

very useful for pharma regulatory graduates and professionals, thank you to coursera team...great job

创建者 NARAYANA M G

May 23, 2020

I learned s many new things from this course. Thanks to every presenter, they are well experienced

创建者 Angel G R L

Oct 24, 2019

an excellent course for those who want to understand better the whole process of Drug development.

创建者 MD R A

Apr 29, 2020

This course is very good. A person from the pharmacy field gets to learn a lot from this course.

创建者 Diana M

May 22, 2020

Good course. But should be more updated information, if all the same regulation is still valid..

创建者 Jonas I D G

Jul 01, 2020

I really like the teachers and the Quiz. I hope this course will help me landing my next job!

创建者 PAOLLA S G

Mar 12, 2020

Super interessante!! Me ajudou muito a entender sobre novos medicamentos e suas legislações!!

创建者 Jony M

Mar 21, 2020

I have found this course good in terms of the content and lectures given by the instructors.

创建者 saijyotheswar a

May 31, 2020

very a good approach for the online courses and can learn the things outside the limit

创建者 Mrs. J P

May 10, 2019

Was a very informative course, gave me an overview of entire drug development process.

创建者 Faisal N K

Sep 25, 2019

Highly recommended, very insightful and gives a broad overview of Drug development.

创建者 Gaanappriya M

May 12, 2020

iNTERESTING COURSE WITH EXCELLENT MATERIALS. A GREAT READ AND A FABULOUS EXPERIENCE!

创建者 Ibis A M

Feb 09, 2017

Great course, great lectures and interesting subject. Learned a lot in a short time.

创建者 Kai Y

Dec 11, 2019

quite well-structured lecutres with rich-experienced professionals of industry

创建者 TAN L N N

May 02, 2017

It's amazing experience. I had the opportunity to get access to new knowledge

创建者 Rutuja t

Jun 08, 2020

it was a great course i aquired so much knowledge about the clinical trails.

创建者 Md. A S

May 23, 2020

Really awesome course. Anyone can get a better idea about drug development.

创建者 Brittany N A

Aug 21, 2019

I truly enjoyed this course. I learned some valuable information in the

创建者 Tharini C

Jun 20, 2020

Got a thorough basic idea on all aspects involved in drug development.

创建者 Saleem A

May 18, 2020

I was able to listen to the course while commuting and learned a lot.