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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: 226 - 250 / 405 レビュー

by Leah F

2020年4月9日

so interesting

by Daniela P Q C

2022年3月9日

Very complete

by Andrey K

2021年8月9日

Great course!

by Mehedi H R 1

2020年8月29日

Great course.

by S.Nandha k

2020年6月12日

Useful course

by Anirudha D

2021年6月28日

Very helpful

by Jonathan M

2020年12月1日

Excellent!!!

by MRS. S

2020年8月25日

Very helpful

by Rafael V

2020年7月12日

Great Course

by monika k

2022年8月3日

very useful

by parikshith s d

2020年8月31日

magnifisant

by MUHAMMAD B

2020年5月11日

Its awesome

by Akshay T

2019年6月22日

good course

by Sudarahan S K

2020年10月10日

Its 5 star

by Sourav M

2018年9月21日

Thank you.

by Mohamed S T

2017年9月5日

Excellent.

by CS M L

2020年11月4日

excellent

by Alessandro G

2020年8月30日

excellent

by Abhishek M J

2020年8月1日

Excellent

by srinivas r b

2020年7月25日

Excellent

by botta a d

2020年7月23日

Very good

by PRIYA P

2020年7月2日

excellent

by Akhil N A

2020年5月30日

Excellent

by Rasel A

2020年1月6日

Excellent

by vinay y

2019年4月24日

very good