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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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1,977 classificações
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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!

Filtrar por:

151 — 175 de 401 Avaliações para o Desenvolvimento de medicamentos

por KEERTHIKA s

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17 de set de 2020

Very interesting course. I am so happy. Thank you

por John A

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2 de dez de 2020

the course is informative and easy to understand

por Pathak K J

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29 de mai de 2020

Good for learning and thank you for your support

por Mrs. P S A

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14 de mai de 2020

I loved to learning the drug development course.

por Samiya K

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26 de jan de 2020

this course prooved to be really very beneficial

por Sneha B G

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18 de mai de 2020

Best Course to Learn Drug development process.

por Shivam d

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1 de mai de 2020

I found it more knowledge... Tq so much for it

por Saloni k

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16 de jul de 2020

It was a very useful and knowledgeable course

por Dr H J

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18 de mai de 2020

It was a NICE EXPERIENCE AND LOTS OF LEARNING

por Mritunjoy b

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9 de jul de 2021

what a go....stay healthy have a proper diet

por ALISA C D

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10 de ago de 2020

Very helpful. I got exactly what I expected.

por faryal f

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1 de out de 2019

it was very informative and i loved doing it

por SarathyVarman A

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31 de jul de 2021

best for basic learner in clinical research

por Jivesh G

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24 de jun de 2020

Such an interesting and informative course.

por SYEDA K F

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15 de mai de 2020

very nice effort by university of San Diego

por Beatrice M

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15 de fev de 2017

Great Class. We need more of these courses.

por Abhishek P

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20 de jun de 2020

Best course to give wide view into drugs

por Noor F M I

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7 de jun de 2020

very beneficial class, easy to understand

por George W

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12 de out de 2020

very well organized and very informative

por Matías G

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14 de mai de 2020

Very good intrudction to all the trials

por Abdulkader

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11 de ago de 2019

Great course, well experienced teachers

por Refath R

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11 de ago de 2021

I learned details on drug development.

por Larissa L G

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11 de jun de 2020

Well structured and designed course!!

por Eduardo A

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18 de dez de 2020

Very informative and great lectures!

por Akanksha S

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20 de abr de 2021

this course is very helpfull for me

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