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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



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 (, Drug Development and 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....



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!


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.


医薬品開発: 26 - 50 / 332 レビュー

by divya


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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

by Karonaa R


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


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


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


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

by Arunima R


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