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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 reseñas

HG
15 de oct. 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.

KR
24 de may. 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!

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351 - 375 de 379 revisiones para Desarrollo farmacéutico

por Diego R

13 de sep. de 2020

This wasn't really great, it is a recording of several seminar presentations that were recorded several years ago, for this, the landscape has changed but the content hasn't, also, as this was planned for a in person presentation, the format is not optimal for a MOOC.

por Francisco M

12 de oct. de 2020

Me ha gustado bastante, he aprendido mucho con el curso. Aún así hay un aspecto que me afecta y es que s habla muy poco de la legislación a nivel europeo y eso hace que me sea menos util para mi formación.

por Matthew L

6 de ene. de 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

30 de jun. de 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

25 de sep. de 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 Mrunmai D M

5 de sep. de 2020

it was a great learning with coursera. it was indeed an informative course and glad hearing the prominent and experienced speakers

por Krithika S K N

2 de sep. de 2019

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

por Adrija C

2 de nov. de 2020

US- centric course. The content in week 3 was not well explained and felt rushed.

por Aneesh T G

23 de ago. de 2020

More emphasis on the filing and submissions and approvals need to be there

por Carolina S V

27 de dic. de 2017

Weeks 1 and 2 are great, but the classes of week 3 need more organization.

por Damien V

17 de sep. de 2018

good up to phase 2 (included). Phase 3 and after was less informative

por Brian M

25 de abr. de 2021

It's from 2013. Good overview but time for an update.

por Miguel M V

31 de ago. de 2020

would like an specialization on this matter

por Budupula K

19 de jun. de 2021

I gained knowledge

por Sofia B J

2 de sep. de 2020

goooooood

por rahul r

15 de sep. de 2021

good

por DR. A G

5 de sep. de 2020

good

por Pratiksha

2 de jun. de 2020

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por Dale G Y

24 de ago. de 2021

Had hoped to hear a better description of the types of trials and more about the Regulators' logic in deciding what trials a drug must have - PK for ANDA? BE for ANDA? P1 and P3 for 505B2? Does PK=P1? These topics are useful. Need to define these options and explain the reason for using them for different scenarios. That's part of what I expected from Drug Development.

The lecture style of second half was difficult. More structure, clear pronunciation, less random thoughts about unexplained topics.

por Mohamed T H

18 de jul. de 2020

Phase 1 was explained nicely. But phase 2 description was unclear with some diagrams with not much context and a lot of acronyms thrown around. Did not learn a lot about phase 3 either. The presentation slides were very busy like the previous course.

por Malamati V

23 de oct. de 2020

I felt like the lectures were not so organized as far as their material is concerned. I also found the overall course more "business-oriented" than actually educational.

por Alejandro G

28 de may. de 2020

The course was not structured as an online course. the slides were quite boring and some of the speakers were not enthusiastic

por Arash Y

3 de mar. de 2018

Presentation slides and sound quality is at its lowest.

por Maria B

18 de mar. de 2020

The course is not prepared for online course

por Benoit E

21 de feb. de 2019

A lot too much bla bla on the Phase iv part