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Opiniones y comentarios de aprendices correspondientes a Desarrollo farmacéutico por parte de Universidad de California en San Diego

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228 revisiones

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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....

Principales revisiones

HG

Oct 16, 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

May 25, 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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151 - 175 de 227 revisiones para Desarrollo farmacéutico

por Uma M K

Jun 21, 2020

Good

por Dhobi N

Jun 10, 2020

Good

por sagiraju j s

Jun 10, 2020

good

por yatam s r t

Jun 08, 2020

good

por MASHETTY V

May 19, 2020

Good

por sowjanya g

Mar 04, 2019

good

por Mohammad j s

Sep 23, 2017

good

por josephmary

Jun 18, 2020

yes

por K V S R

May 24, 2020

yes

por Nwando O

Feb 09, 2020

E

por Sailaja B

Jul 10, 2019

N

por Alan Q

May 17, 2018

E

por Arman A

May 08, 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 Valery T

May 27, 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

Jun 25, 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

Feb 18, 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 Vanja T F

Feb 22, 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

Oct 15, 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

Feb 25, 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 AMUCHILANI W

May 12, 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

Feb 16, 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

Jul 05, 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

Jul 17, 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

Jun 24, 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

Apr 03, 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.