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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

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1,978 classificações
403 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

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.

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!

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326 — 350 de 401 Avaliações para o Desenvolvimento de medicamentos

por Nadia C

30 de jan de 2020

some of the things was a little bit old - But i liked the content and the concepts

por Aderbal A

18 de abr de 2021

the course is good, but classes are old and outdated. Many classes are lectures.

por Yury K

2 de dez de 2019

Need to update the lectures to reflect rapidly changing regulatory issues

por Hiep X N

5 de ago de 2017

Informative course, instructors have a great deal of industry experiences

por abbas a

28 de mai de 2020

It was very helpful to me,and I learned much better in this quarantine.

por Vindhya S R

6 de nov de 2020

It was indeed a great course. It was quite informative. Thank you!

por Morongwa

26 de mar de 2020

Thoroughly enjoyed this. Could do with an updating of materials.

por Ugbosu F O

27 de mai de 2021

It was at first looking boring but i ended up having a nice time

por INMACULADA R L

10 de set de 2020

Me ha parecido muy interesante el mundo farmacéutico-industrial.

por shubham b

21 de set de 2021

i have learned all the phases in brief thanks to coursera .

por Matthew K

3 de ago de 2017

Good primer on Drug Development albeit very high level.

por Avishek S

27 de ago de 2020

It can be more arranged and in detail.

but pretty good.

por Alex

25 de abr de 2019

A very interesting lecture on drug development stages.

por Mahesh W

21 de fev de 2022

I know deeply the details of phases clinical trials

por ABHISHEK S

5 de nov de 2020

An amazing way to learn drug development studies.

por Pao-Sheng C

2 de mar de 2017

Brilliant framework and well designed structure

por Rekhakumari C

17 de ago de 2020

INFORMATIVE & GOO EXPERIENCE . THANKYOU..

por VIHAN S

21 de jun de 2020

Very informative and illustrative course

por Hesham E

26 de mai de 2020

Wonderful journey in drug lifecycle.

por VINEET A

14 de mai de 2021

It was very informational,

THANK YOU

por ABHIRAM P G

23 de set de 2021

very informative wrt formal aspect

por Rajan D

2 de mai de 2022

t​rials and their usage is great.

por ABHIJEET N

28 de jul de 2020

need more elaborated lectures

por Kurre B

5 de jul de 2020

Nice and very well explained

por MUSAIB Z

27 de mai de 2020

This course was very useful