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Voltar para Desenvolvimento de medicamentos

Comentários e feedback de alunos de Desenvolvimento de medicamentos da instituição Universidade da Califórnia, San Diego

4.7
estrelas
1,956 classificações
401 avaliações

Sobre o curso

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....

Melhores avaliações

KR

24 de mai de 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!

HG

15 de out de 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.

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276 — 300 de 400 Avaliações para o Desenvolvimento de medicamentos

por Nwando O

9 de fev de 2020

E

por Sailaja B

10 de jul de 2019

N

por Alan Q

17 de mai de 2018

E

por Arman A

8 de mai de 2020

The course content is very good and the lecturers are highly knowledgeable in their fields. However, this course is a recording from a meeting (or conference) which is a bit distracting. People asking questions and two of the female lecturers were kind of laughing / joking a lot during this serious course. Also the one who was telling about FDA (in week one) was kind of saying "Oh, I don't know that.. I am not gonna talk about that.. You should have known.." This is a course and that's not I want hear from the lecturer. I felt that this meeting was not recorded for Coursera. It seems like someone said "Oh, we have the recording of this meeting and why not sell it on Coursera?". That's why I gave 4 stars.

por ananda

4 de mai de 2021

Lots of good material despite covering a broad subject area. Phase 2 lecturer and content was the highlight for me. As was the case in the related Discovery course, the Development course content is primarily drawn from a series of guest lectures as opposed to content designed from the ground up specifically for this Coursera class. An unfortunate result is rushed and/or glossed over topics. For instance, the Phase 1 guest lecturer ran out of time and skipped several slides he was planning on covering. There was also a drop off in usefulness for me in terms of Phase 3 clinical design considerations and evaluations.

por Valery T

27 de mai de 2018

Thisa course was very intersting to learn more about new drug application 2 years before applying to the FDA, the week 2 and 3 clinical trials and regulatory aspects were very interesting. The format of assessment can be like content of 3/4 page and then the individual selects an option as to what to do to rectify the information. That is a more efficient process to creatively think and do the regulations job in a real world scenario. I had no hesitation in doing this course and would do it again. Very useful for my background of medical technician and analytical chemistry degrees.

por Venkat R R

25 de jun de 2020

The initial sections of the course was interesting like preclinical and clinical, but some improvements needed for the later part of the course like NDA and commercialization. Overall, the content of the course needs to be updated to reflect the current pharma development process in terms of drug spending; approval time and new FDA review pathways; no, of drugs approved by each review pathway; and latest therapeutic advancements happening and how FDA views them. Hope these points will be considered in improving the course learning relevant to the current times.

por miranda w

18 de fev de 2020

I think the Course name should be changed - Drug Development - Clinical Trials through the phases.

It is super useful for people wanting to learn about clinical trials, it is mostly about clinical trials BUT the name of the course doesn't convey this, so a propospective employer in clinical trials wont care about this course because the name isnt informative enough about what you taught

por Aedrian A

16 de jan de 2021

This course adequately introduced the issues and the reality of the drug development process through the several expert presenters. Being interested in this field as an outsider, I appreciate the level of detail shared in the course. However, similar to the first part of the Coursera Specialization where this course belongs, the material seems outdated as well.

por Vanja T

22 de fev de 2018

Very good talks and presentations, amazing speakers, lots of interesting information, very valuable course.

But OLD - the course needs major renewal, with new data and new talks. Same for power point presentations: most of them are totally useless, hard to understand and follow and just do not look nice. Please prepare better presentations for the next course.

por Brendan D

15 de out de 2017

Overall the content was relevant to drug development and presented in an organized manner. The presenters seemed to have a wealth of experience in development. This was my first time using Coursera and I enjoyed being able to pick up where I left off. I was disappointed with the course transcriptions as there were many inaccuracies.

por Güliz T B

25 de fev de 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.

por Jamal E

4 de jul de 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.

por AMUCHILANI W

12 de mai de 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.

por Momchil N

16 de fev de 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

por George W

5 de jul de 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.

por Ashwini K

17 de jul de 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.

por Abram S

24 de jun de 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.

por Jonathan P

3 de abr de 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.

por Amjad N

3 de mar de 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

por Subramanian K

2 de set de 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.

por Elena B

21 de abr de 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.

por Divya G

12 de jun de 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.

por Dr. V A

29 de abr de 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.

por Suda J

1 de ago de 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.