Chevron Left
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
1,529件の評価
334件のレビュー

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

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.\n\nThank you!

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.

フィルター:

医薬品開発: 26 - 50 / 332 レビュー

by divya

2020年6月20日

first i would thank full to coursers because i learn so many things from this drug development course , this course is not that munch difficult if you pay interest on it and it is very useful course for pharmacy and biotech students...

by Nishtha C

2020年5月21日

I completely enjoyed the course and got abundant knowledge about the FDA, Clinical trials different phases and Industrial considerations, NDA . The graded assignments are useful too.I will surely recommend this course.

by Tanmayi K P

2020年6月11日

I learned a lot from this course about drug discovery and development. it's going to be really helpful for me in my further studies. All professors were really good and humorous at times. I enjoyed all the lectures.

by V D N K A

2020年5月2日

excellent and usufull information by this course. After learning this course I can able to say that this course provides very good information related to drug discovery and also useful to my furthur research

by Farabi S S

2020年9月14日

As a future pharmacist , this course will going to highlight my career or in my study to achieve success .

I want to thank all of the instructors !!!!

They did their job effectively ....

So , thanks again !!!!

by Kadam S R

2020年5月25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!

by Mohammad T

2020年6月9日

Clinical trial are most important part of pharma sector for drug development and development of a molecule

It's important to all of us whose involved in research and development

Thank you!!!

by Heidi D M D

2020年8月3日

Great introduction to the nuances of drug development, post research and into clinical and commercial aspects. I feel much more ready to enter the regulatory affairs arena after this.

by Kratika Y

2020年5月29日

This course helps to clearly categorize the different phases of clinical trial. It could be great course for the people even with zero background knowledge of clinical trail

by Michael R

2018年7月19日

Information in the course is very practical. I come from basic biology background and now with this course I gained some real insights about how the clinical trails happen.

by Nityasri V

2019年9月26日

Thank you very much for covering all Phases of clinical trial. Very useful and informative. Thank you for providing me with the financial aid to complete this course.

by Dr R L

2020年8月19日

Thank you the opportunity to learn this wonderful course. Its really a good course for those who are interested in drugs and the development procedures and protocol.

by humera k

2020年8月1日

The excellent course for the complete study for drug development ,its trial ,marketing and learning all aspects about the study of drugs before coming to the market

by Sindy O P

2019年6月16日

Great course for learning the basics of the drug development process from clinical trials to filling marketing and post-marketing commitments. Great place to start!

by Ohakwe N G

2020年9月17日

Amazing. The Lecturers made this topic very interesting and informative, gave very good examples and analogies to help understanding easier. Thanks, UC San Diego

by Courtney Z

2019年1月29日

I would recommend this course to anyone curious about the pharmaceutical industry to better understand the process of drug development from start to finish.

by Eva K

2019年10月24日

Thank you, this course gave me basic understanding of drug development and clinical trials and I hope, it will help me to find new job position.

by Gadela V R

2020年5月20日

It has been of a great use. To those who are dealing with pharmaceuticals, this course is helpful. The lectures are explained in a lucid manner

by Antonio F

2020年8月12日

This course was fantastic! I must say sometimes important points were not on slides, so it would be beneficial to watch videos more than once!

by Vaibhav T

2019年2月1日

The concepts were concisely explained but the prerequisites from Drug Discovery helped a lot. The lectures were very informative and engaging.

by Karonaa R

2020年4月21日

Good course, which can be easily understands to all. Thank you who are all taken such a useful and very informative sessions. Good luck all.

by debaprasad g

2020年6月1日

Last lectures were too much discussions rather than lecture, please include some informations those were told verbally but not in the ppts.

by chenyang j

2020年8月3日

very clearly illustrated the clinical trial from phase 1 to phase 4 and with border and depth thought of the present regulation by the FDA

by Malavika

2020年10月18日

Excellent course, well explained for a beginner and definitely would leave with further interest in studying something of similar nature.

by Arunima R

2020年6月5日

very helpfull insights to the clinical trials, high;y recommend to whoever has interest in drug development , commercialization and DRA