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Avis et commentaires pour d'étudiants pour Développement de médicaments par Université de Californie à San Diego

4.7
étoiles
1,842 évaluations
387 avis

À propos du cours

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....

Meilleurs avis

HG
15 oct. 2018

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
24 mai 2020

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!

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276 - 300 sur 385 Avis pour Développement de médicaments

par Güliz T B

25 févr. 2020

I recommend this course together with Drug Discovery and Drug commercialization to everybody that would like to have an overview of pharmaceutical industry, however one should also keep in mind that these lectures are from 2013. It would be better if the lectures were more up to date. Then, I would give 5 stars.

par Jamal E

4 juil. 2021

The course is enriched with a lot of information that I learnt, but its just the first and second weeks tutors aren't suitable for teaching, their dialects aren't English. But all in all it was a great course and I may return and take the other 2 courses in this specialization.

par AMUCHILANI W

12 mai 2020

How glad i am, this was fantastic, its an excellent course and i believe i have done tremendously well. Thank you UC SAN DIEGO in collaboration with coursera, i wish to progress to my masters degree if i can get an opportunity to the university of UC SAN DIEGO.

par Momchil N

16 févr. 2020

I truly enjoyed the lecture content and am thankful for the course.

For me, the lectures in week 3 need to be updated and changed. I was confused by the two lecturers taking on each other. I found the lecture material of the others speakers better organized

par George W

5 juil. 2019

This is an informative course on clinical trial development and regulatory considerations of drug development. However, I wish the course content is more updated and organized. The lecture videos are the just recordings from their classes in 2013.

par Ashwini K

17 juil. 2017

Course materials are useful, lectures are very easy to understand, some of the video / sound editing is a bit unclear, since you can't see the presenter talk when the slides are being shown. Overall, a great intro to drug development.

par Abram S

24 juin 2020

Robust review of the intricacies of the clinical trial process and economic considerations throughout. My only regret is that the data is a bit dated (ending 2012/13) and I am curious to see how things have shifted since then.

par Jonathan P

3 avr. 2020

The course started well. But the course about Phase 2 was difficult to digest. Even worst, the course about NDA was long, repetitive, with old data (as old as 2003 !) and some regulation from 2009 ! It need a serious update.

par Amjad N

3 mars 2019

Overall, I liked this course. There are some improvements I would suggest: > list online resources more clearly > define acronyms and provide better definitions > quizzes need to be longer and slightly more challenging

par Subramanian K

2 sept. 2017

The drug labeling seminar was not very informative. Both the presenters seemed to be wanting to go one-up on the other with their respective experiences. The entire session was too casual to be labeled as a lecture.

par Elena B

21 avr. 2018

I would like to see more updated information (i.e. more information on biologicals), current presentation is a bit old (from 2008-2010?)

But it provides good general overview of the clinical development process.

par Divya G

12 juin 2021

I liked the content but I feel it wasn't very engaging and each slide had a lot of text. If there were peer review assignments and activities other than quizzes, the course would have been more interesting.

par Dr. V A

29 avr. 2021

The course was informative and found exactly at the time of need. I was a little disappointed because it's not the latest updated version. looking forward to the updated version of the course.

par Suda J

1 août 2020

It is really informative and nice to learn about such a vast and growing industry. The only complain I have is all the data was from 2012 which has now either been changed or updated.

par Savind C

2 juin 2021

T​he course should be updated. Most of the data presented is almost a decade old. Also, The person who teaches about Phase II trails is not clear, and it is hard to understand him.

par Mary S

14 juil. 2020

I would have loved to have a specific case study to follow as an example of how a drug goes through the whole life cycle as the course felt a bit too high-level overview at times.

par suzana

8 nov. 2020

The course is well organized, but it requires an update of the contents.

It is good for starting and refreshing the topic of clinical trials. I look for the next updated one!

par Urjita J

1 juin 2020

Very detailed and conceptually clear information. lectures are very well designed for online learning. Good distribution of the entire drug dev. procedure. Learnt a lot!

par Hussein S

14 nov. 2017

Provides a good overview on drug development phases and challenges. Some lecturers are from the industry which gives a practical feeling to the whole process.

par Sebastian F

24 janv. 2021

Very well presented, very interesting. As many already mentioned unfortunately the material and data is a little out of date. Nevertheless, very good course.

par Muhamed S E

13 août 2017

Great Course , although i had some hardships understanding some parts and i had to search it online on my own ,, but overall i would recommend it !

par yousef e

28 sept. 2019

i think you should put the speaker talking videos also in the lec not only the slides this will give more intent to complete the course faster

par Karen O

30 juin 2020

Week 3 was the best! Both lecturers had loads of experience in industry, and shared all that knowledge with practical and real-life examples.

par Jahnavi

13 oct. 2020

It is an amazing course that provides an practical insight into the field of clinical research. Thank you so much for your help and support.

par Álvaro S V

7 mars 2019

This course gives a wide overview about clinical trials and all the process needed to launch a new drug. I really enjoyed it.