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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
1,999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: 201 - 225 / 405 レビュー

by Tahir H

2019年12月23日

It was a good experience

by RANTHU A

2020年7月2日

giving more information

by Israel V V

2020年6月22日

I learned a lot, thanks

by Chintan B

2019年8月26日

Very Informative course

by Jyoti B

2022年1月31日

The course is ecellent

by Pratik P

2020年4月22日

Nc course it's useful

by RHIANE A C

2020年10月1日

Knowledgeable course

by Choudhary S A

2022年1月5日

e​excellent course

by ankita p

2021年9月17日

informative course

by Akilesh

2020年6月13日

Very useful course

by Magdoline N N

2019年10月9日

Very useful course

by Raghad K

2021年8月20日

v​ery informative

by Rodney T

2021年3月26日

Very good course.

by Sarah s

2020年11月19日

Veryy nice course

by Melody F

2020年7月19日

Excellent course!

by J P V

2020年5月26日

nice course .....

by aula s

2020年1月6日

Thank you so much

by Mahmoud A

2021年12月3日

Drug Development

by Sanchit V

2020年5月17日

excellent course

by Yuvashini E

2020年1月10日

was very helpful

by Gozde I A

2019年9月2日

Very informative

by SAMEER A

2018年7月25日

EXCELLENT COURSE

by Anthony E J T

2020年7月26日

Muy informativo

by julio r l

2020年5月5日

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by Shikha K

2020年6月7日

great learning