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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

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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: 251 - 275 / 405 レビュー

by JARUGUMALLI S S K C

2019年3月3日

Great...!

by Anna P

2020年3月30日

Отлично!

by stines j

2021年8月18日

helpful

by Dr. N F

2020年5月12日

awesome

by DR S D

2022年1月8日

useful

by E01203139-SHERLIN S T B B

2020年9月26日

Useful

by Sowmiya N

2020年6月10日

cheers

by BAALOUDJ O

2020年6月2日

THANKS

by DEVENDRA B

2022年1月4日

​good

by shekinah g

2021年3月23日

Thank

by Basheer A N

2021年9月22日

good

by Sohel S

2020年11月10日

good

by Dr M

2020年9月16日

nice

by DIVYA S K

2020年9月15日

Nice

by 19BBT006-ANASWAR S B B B

2020年9月12日

Nice

by Hrithikroshan

2020年9月10日

Good

by GLORIYA V

2020年8月24日

Good

by Uma M K

2020年6月20日

Good

by Dhobi N

2020年6月10日

Good

by sagiraju j s

2020年6月10日

good

by yatam s r t

2020年6月8日

good

by MASHETTY V

2020年5月19日

Good

by sowjanya g

2019年3月4日

good

by Mohammad j s

2017年9月23日

good

by josephmary

2020年6月18日

yes