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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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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.

Thank you!

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226 — 250 de 405 Avaliações para o Desenvolvimento de medicamentos

por Leah F

9 de abr de 2020

so interesting

por Daniela P Q C

9 de mar de 2022

Very complete

por Andrey K

9 de ago de 2021

Great course!

por Mehedi H R 1

29 de ago de 2020

Great course.

por S.Nandha k

12 de jun de 2020

Useful course

por Anirudha D

28 de jun de 2021

Very helpful

por Jonathan M

1 de dez de 2020

Excellent!!!

por MRS. S

25 de ago de 2020

Very helpful

por Rafael V

12 de jul de 2020

Great Course

por monika k

3 de ago de 2022

very useful

por parikshith s d

31 de ago de 2020

magnifisant

por MUHAMMAD B

11 de mai de 2020

Its awesome

por Akshay T

22 de jun de 2019

good course

por Sudarahan S K

10 de out de 2020

Its 5 star

por Sourav M

21 de set de 2018

Thank you.

por Mohamed S T

5 de set de 2017

Excellent.

por CS M L

4 de nov de 2020

excellent

por Alessandro G

30 de ago de 2020

excellent

por Abhishek M J

1 de ago de 2020

Excellent

por srinivas r b

25 de jul de 2020

Excellent

por botta a d

23 de jul de 2020

Very good

por PRIYA P

2 de jul de 2020

excellent

por Akhil N A

30 de mai de 2020

Excellent

por Rasel A

6 de jan de 2020

Excellent

por vinay y

24 de abr de 2019

very good