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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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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

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!

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.

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226 - 250 de 260 revisiones para Desarrollo farmacéutico

por Alex

Apr 26, 2019

A very interesting lecture on drug development stages.

por Pao-Sheng C

Mar 02, 2017

Brilliant framework and well designed structure

por VIHAN S

Jun 21, 2020

Very informative and illustrative course

por Hesham E

May 26, 2020

Wonderful journey in drug lifecycle.

por ABHIJEET N

Jul 29, 2020

need more elaborated lectures

por Bhavana.K

Jul 05, 2020

Nice and very well explained

por MUSAIB Z

May 27, 2020

This course was very useful

por Muhammed T k

Sep 16, 2017

thanks ,it was interested

por Kiran

May 28, 2020

very useful to beginners

por Seema A G

Apr 22, 2020

Very informative course.

por Manda L p

Jun 04, 2020

very helpful course

por Janet T

Oct 17, 2019

A great overview.

por Nilanjan P

Nov 30, 2019

excellent course

por Shivani

Jul 24, 2020

It is good

por EARRA S

May 30, 2020

Use full

por Shweta S

May 09, 2020

nice

por Paul G

Jun 19, 2020

The information provided by this course was very helpful for someone who is new to the topic and I do feel much better informed as a result. The course itself however is not the most professionally presented. The recordings are of face to face lectures provided to an actual class of students. As such they are designed for online learning where there is no possibility to interact with the speakers and students don't have access to any other course materials. The speakers in the phase 3 and marketing sections didn't really follow their slide packs.

por Eliza V

Jul 16, 2017

The overall material was good. However, the course was not structured as an online course, rather an online posting of in class lectures. This made it difficult to hear the questions of the students as the questions were not repeated by the lecturer and therefore we received an answer to a question we didn't hear. Also, because of the lecture nature, a lot of information was missing from the slides as it was spoken information.

por Mark S

Mar 02, 2020

Several of the questions seemed irrelevant to the actual conduct of clinical research. I also wholeheartedly disagree with #7 in the phase III quiz. The real answer depends on whose perspective you're coming from. Maybe for the pharmaceutical company getting to market is most important, but to the patient I'm pretty sure efficacy is more important to him/her than how quickly other people can make money.

por Marie A B

May 13, 2020

Informative and engaging in the first two weeks of lecture, however the lecturers on the third week were not that enthusiastic and I felt that I didn't gain much knowledge on them. I would suggest to refrain having two lecturers at the same time to maximize the time on the topic itself.

por Bhavana S

Jul 02, 2020

I found the first two weeks to be very helpful - week 3 was less structured in terms of the lecture content. I also think this whole course should be updated since many regulations have changed since the course was posted.

por Matthew L

Jan 06, 2020

Week 3 lectures were not as in-depth as hoped and filled with too many personal anecdotes for the time allowed. Much more could have been said if these had been skipped.

por Kayla A C

Jun 30, 2020

Would be nice to update this course. The slides are from 2013 and I am listening in 2020. A lot has changed in the pharmaceutical market since in that time.

por Nikolai W

Sep 25, 2019

The name of the course should be something a la 'Clincal trials and drug admistration agencies'. It is not the development of a drug.

por Krithika S K N

Sep 02, 2019

Was informative. The lectures could have been more structured and slides more detailed.