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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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1,835 个评分
386 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 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.\n\nThank 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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26 - 药物开发 的 50 个评论(共 384 个)

创建者 Ikechukwu I

Aug 28, 2020

The course was absolutely wonderful. The instructors we're all very knowledgeable and experienced in their fields. Though the course slides were a few years old (2013) it still was accurate and informative. It's definitely a requirement of you're interested in venturing into drug study, clinical trial investigations, regulatory affairs. I'd highly recommend.

创建者 Luma M

May 17, 2021

Excellent course! It contributed a lot to my learning and to improve my curriculum. With regulatory approaches and important considerations on the phases of clinical trials, the course has excellent teachers, with extensive experience and knowledge. Thanks!

创建者 Kajal M

Aug 9, 2020

Overall, I have been very happy with my experience using Coursera and think it is one of the best online learning platforms.Actually, you can learn anything you want from the world's greatest minds. This is a brand new way of learning new things.

创建者 divya

Jun 20, 2020

first i would thank full to coursers because i learn so many things from this drug development course , this course is not that munch difficult if you pay interest on it and it is very useful course for pharmacy and biotech students...

创建者 WishCasting

Apr 17, 2021

Wonderful course, excellently structured, great speakers.

Thank you UCSD and Coursera for having put this course together, helping the multitude out there in need of practical information, of such a great and interesting industry.

创建者 Shayan S

Jun 28, 2021

A Fabulous course indeed! Just like the other courses of UCSD. Also, you will find it very difficult not to fall in love with Kelly Hogan and her character and how she lectures through the 3rd week! she is just AWESOME!!!

创建者 Nishtha C

May 21, 2020

I completely enjoyed the course and got abundant knowledge about the FDA, Clinical trials different phases and Industrial considerations, NDA . The graded assignments are useful too.I will surely recommend this course.

创建者 Tanmayi K P

Jun 11, 2020

I learned a lot from this course about drug discovery and development. it's going to be really helpful for me in my further studies. All professors were really good and humorous at times. I enjoyed all the lectures.

创建者 V D N K A

May 2, 2020

excellent and usufull information by this course. After learning this course I can able to say that this course provides very good information related to drug discovery and also useful to my furthur research

创建者 Farabi S S

Sep 14, 2020

As a future pharmacist , this course will going to highlight my career or in my study to achieve success .

I want to thank all of the instructors !!!!

They did their job effectively ....

So , thanks again !!!!

创建者 Kadam S R

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.

Thank you!

创建者 Mohammad T

Jun 9, 2020

Clinical trial are most important part of pharma sector for drug development and development of a molecule

It's important to all of us whose involved in research and development

Thank you!!!

创建者 Md. S I

Aug 22, 2021

It is a great pleasure for me to complete successfully this course and thanks to the course coordinators and teachers. This course will open my bright future to the pharmaceutical career.

创建者 Heidi D M D

Aug 3, 2020

Great introduction to the nuances of drug development, post research and into clinical and commercial aspects. I feel much more ready to enter the regulatory affairs arena after this.

创建者 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

创建者 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.

创建者 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.

创建者 Dr R L

Aug 19, 2020

Thank you the opportunity to learn this wonderful course. Its really a good course for those who are interested in drugs and the development procedures and protocol.

创建者 humera k

Aug 1, 2020

The excellent course for the complete study for drug development ,its trial ,marketing and learning all aspects about the study of drugs before coming to the market

创建者 Sindy O P

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!

创建者 Ohakwe N G

Sep 17, 2020

Amazing. The Lecturers made this topic very interesting and informative, gave very good examples and analogies to help understanding easier. Thanks, UC San Diego

创建者 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.

创建者 vidya m

Jul 28, 2021

The speakers and the course content are very good. it gave me a good understanding of the different trial phases and the challenges in each one of them.

创建者 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.

创建者 A U

Mar 28, 2021

Lots of valuable information - like one of the instructor said its not even scratching the surface. This course is showing where the surface is