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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: 101 - 125 / 405 レビュー

by saijyotheswar a

2020年5月31日

very a good approach for the online courses and can learn the things outside the limit

by Mrs. J P

2019年5月10日

Was a very informative course, gave me an overview of entire drug development process.

by Faisal N K

2019年9月25日

Highly recommended, very insightful and gives a broad overview of Drug development.

by Vinit S

2021年1月8日

Excellent course with detail discussion on clinical trial design at various phases.

by Gaanappriya M

2020年5月12日

iNTERESTING COURSE WITH EXCELLENT MATERIALS. A GREAT READ AND A FABULOUS EXPERIENCE!

by Ibis A M

2017年2月8日

Great course, great lectures and interesting subject. Learned a lot in a short time.

by Sivakumar S

2020年9月2日

Got an understanding of what is actually going on in the pharmaceutical industries.

by Nirav S

2021年4月21日

The course was really helpful and interesting. Thank you for such a good course.

by Kai Y

2019年12月11日

quite well-structured lecutres with rich-experienced professionals of industry

by TAN L N N

2017年5月1日

It's amazing experience. I had the opportunity to get access to new knowledge

by Rutuja T

2020年6月8日

it was a great course i aquired so much knowledge about the clinical trails.

by Md. A S

2020年5月23日

Really awesome course. Anyone can get a better idea about drug development.

by Dr.M N

2020年7月7日

Very informative course for learning different stages of drug development

by Ana S G C

2021年5月30日

Very educatinal and eye openning in regards to pharmaceutical processes

by Brittany N A

2019年8月21日

I truly enjoyed this course. I learned some valuable information in the

by prathamesh k

2020年7月24日

Touched the More Technical aspects in core pharmaceutical Development.

by Tharini C

2020年6月20日

Got a thorough basic idea on all aspects involved in drug development.

by Christina A

2020年10月18日

Excellent course. Easy to follow and comprehend a very complex topic.

by Saleem A

2020年5月18日

I was able to listen to the course while commuting and learned a lot.

by Rujuta M

2020年5月31日

I am immensely thankful to courser for providing this platform to us

by BODDEPALLI A S

2020年6月2日

very useful for those who are worlking in research and development

by kayde z

2020年3月14日

very helpful. useful information about the pharmaceutical industry.

by Baddela S B

2020年4月11日

Good course and refreshment on learning with a day to day examples

by MARIA C A P

2020年9月10日

Muy buen material académico y ejemplos por partes de los docentes

by Abburu S

2020年5月23日

Its a wonderful course, its very useful for new drug application