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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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1,888 classificações
392 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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176 — 200 de 390 Avaliações para o Desenvolvimento de medicamentos

por Lankadi D

24 de Mai de 2020

Its an excellant course i loved it

por Joana d a R

21 de Mar de 2021

I've really enjoined this course.

por Chanky M

18 de Ago de 2020

good course for a master students

por Bhagyashri B

21 de Out de 2020

I learn something new nformative

por Erica K T

27 de Mar de 2020

Very informative, easy to follow

por Prasun N

19 de Jun de 2020

It was nice experience for me .

por Ashish S S

7 de Jun de 2020

Awesome course its just amazing

por Akshay S S

2 de Jul de 2019

This course is really helpful.

por Samuel R .

12 de Jun de 2020

Very usefull course thank you

por Moataz A A A

29 de Set de 2019

excellent one and very useful

por Rakshaa K

6 de Set de 2020

Very useful and interesting

por Raji L M

15 de Jan de 2020

Detail and an amazing course

por Tonia T

20 de Mai de 2019

Well organized and relevant.

por Roshani S P

9 de Set de 2020

best course study material.

por Saras H T

12 de Ago de 2020

it was very fruitful course

por Gaurav b

5 de Jun de 2020

great and very informative

por Nanting N

11 de Mai de 2020

I really enjoy this class!

por Ewmi H R

9 de Out de 2020

A well structured course.

por prudhvi r

21 de Mai de 2020

Easy way of understanding

por Methun P

10 de Ago de 2019

awesome course.i enjoyed.

por Tahir H

23 de Dez de 2019

It was a good experience

por RANTHU A

2 de Jul de 2020

giving more information

por Israel V V

22 de Jun de 2020

I learned a lot, thanks

por Chintan B

26 de Ago de 2019

Very Informative course

por Pratik P

22 de Abr de 2020

Nc course it's useful