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药物开发, 加州大学圣地亚哥分校

4.5
232 个评分
40 个审阅

课程信息

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

创建者 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.

创建者 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:

39 个审阅

创建者 Vaibhav Thakur

Feb 01, 2019

The concepts were concisely explained but the prerequisites from Drug Discovery helped a lot. The lectures were very informative and engaging.

创建者 Courtney Zeni

Jan 29, 2019

I would recommend this course to anyone curious about the pharmaceutical industry to better understand the process of drug development from start to finish.

创建者 shaurya deep bajwa

Jan 23, 2019

this course is really very informative especially for those who are new to this field and even those who are experienced. I highly recommend to attend this great program

创建者 James Dunn

Jan 15, 2019

Great course, but some of the information is becoming outdated due to the course being from 2013

创建者 Philip Riedel

Dec 02, 2018

Fantastic course, learned a lot of new things. Will go for the drug discovery course next. Consider including the presentations before the tests rather than afterwards

创建者 Adrián Posado Fernández

Nov 12, 2018

The course is very informative, specially for people with no experience nor specialized formation in Clinical Trials. However, it is not very detailed nor demanding, so I doubt about its usefulness for someone with previous university formation in clinical research field.

创建者 Heather Grace

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.

创建者 Sourav Mukherjee

Sep 21, 2018

Thank you.

创建者 Damien Veauvy-ext

Sep 17, 2018

good up to phase 2 (included). Phase 3 and after was less informative

创建者 Michael Doyle

Sep 02, 2018

My only comment is minor - I like to print the slides and make notes on them as I listen to each lecture. I have used so much ink up printing them due to them having blue backgrounds etc. It would be good for future courses that the slides can be made just in black and white with minimal use of colour.