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返回到 药物开发

學生對 加州大学圣地亚哥分校 提供的 药物开发 的評價和反饋

4.6
771 個評分
172 條評論

課程概述

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....

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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.

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!

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26 - 药物开发 的 50 個評論(共 177 個)

創建者 Kratika Y

May 29, 2020

This course helps to clearly categorize the different phases of clinical trial. It could be great course for the people even with zero background knowledge of clinical trail

創建者 Michael R

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.

創建者 Nityasri V

Sep 26, 2019

Thank you very much for covering all Phases of clinical trial. Very useful and informative. Thank you for providing me with the financial aid to complete this course.

創建者 Sindy

Jun 16, 2019

Great course for learning the basics of the drug development process from clinical trials to filling marketing and post-marketing commitments. Great place to start!

創建者 Courtney Z

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.

創建者 Eva K

Oct 24, 2019

Thank you, this course gave me basic understanding of drug development and clinical trials and I hope, it will help me to find new job position.

創建者 Gadela V R

May 20, 2020

It has been of a great use. To those who are dealing with pharmaceuticals, this course is helpful. The lectures are explained in a lucid manner

創建者 Vaibhav T

Feb 01, 2019

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

創建者 Karonaa R

Apr 21, 2020

Good course, which can be easily understands to all. Thank you who are all taken such a useful and very informative sessions. Good luck all.

創建者 Harie V

Feb 17, 2020

I find the course to be extremely informative due to the fact that actual industrial people have handled the drug development course.

創建者 Mohamed A

Oct 15, 2019

It was a great course teaching me many things about drug development. cannot wait to go to the third course a Drug commercialization

創建者 SAMUEL E R

Aug 04, 2019

Esta genial para aprender el desarrollo de fármacos, es eficaz y puedes utilizar varios archivos para completar toda la información

創建者 Pankaj K D

May 06, 2020

such a great course where I found very important information. This course helps me to develop my knowledge about Drug Development

創建者 Swarnadeep B

May 13, 2020

Very good for a beginner as well for revising all basics of drug development, Thank you Coursera and UCsan Diego university

創建者 Prathap D

Apr 10, 2020

The course designed very well, as i have been working in Regulatory Affairs, the content and discussions were very useful.

創建者 Niki P

Apr 11, 2020

Excellent course with very well defined topics covered stepwise by experts in each field with real practical examples.

創建者 Vivek H R

May 25, 2020

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

創建者 Philip K L L

Nov 13, 2016

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

創建者 Afroj K

May 13, 2020

Its A good Opportunity to learn the drug development.

very well explained.

thank you for such opportunity.

創建者 Manish K

Apr 26, 2020

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

創建者 Ravi K R J

May 12, 2020

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

創建者 NARAYANA M G

May 23, 2020

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

創建者 Angel G R L

Oct 24, 2019

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

創建者 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.

創建者 Diana M

May 22, 2020

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