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医薬品開発 に戻る

カリフォルニア大学サンディエゴ校 による 医薬品開発 の受講者のレビューおよびフィードバック

4.7
2,000件の評価

コースについて

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....

人気のレビュー

HG

2018年10月15日

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

2020年5月24日

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!

フィルター:

医薬品開発: 176 - 200 / 405 レビュー

by Md. F R S

2020年7月14日

A course full of valuable contents.

by dr a a h

2019年8月20日

I enjoyed the course very much.....

by Meenakshi

2021年5月21日

Awesome and extremely informative!

by Lankadi D

2020年5月24日

Its an excellant course i loved it

by Joana d a R

2021年3月21日

I've really enjoined this course.

by Chanky M

2020年8月18日

good course for a master students

by Mayra C

2022年3月20日

very informative and interesting

by Bhagyashri B

2020年10月21日

I learn something new nformative

by Erica K T

2020年3月27日

Very informative, easy to follow

by Prasun N

2020年6月19日

It was nice experience for me .

by Ashish S S

2020年6月7日

Awesome course its just amazing

by Akshay S S

2019年7月2日

This course is really helpful.

by Abhijit k

2022年2月16日

Wonderful Learning Experience

by Samuel R .

2020年6月12日

Very usefull course thank you

by Moataz A A A

2019年9月29日

excellent one and very useful

by Rakshaa K

2020年9月6日

Very useful and interesting

by Raji L M

2020年1月15日

Detail and an amazing course

by Tonia T

2019年5月20日

Well organized and relevant.

by Roshani S P

2020年9月9日

best course study material.

by Saras H T

2020年8月12日

it was very fruitful course

by Gaurav b

2020年6月5日

great and very informative

by Nanting N

2020年5月11日

I really enjoy this class!

by Ewmi H R

2020年10月9日

A well structured course.

by prudhvi r

2020年5月21日

Easy way of understanding

by Methun P

2019年8月10日

awesome course.i enjoyed.