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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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1,976 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

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!

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.

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126 — 150 de 401 Avaliações para o Desenvolvimento de medicamentos

por Felipe R F

19 de jan de 2020

Very good content. Could go more in depth of the studies designs

por Imani

31 de jul de 2020

I truly enjoyed taking this course. It was beyond a refresher!

por Rohan M

23 de abr de 2020

very informative and good teachers.....gained some knowledge...

por Penugonda V L D S S

28 de mai de 2020

very useful and informative....thanks a lot to the instructors

por Chinmay P

29 de jul de 2020

Easy to learn with goof knowledge and just perfect time span.

por Sahil K

14 de ago de 2020

Very helpful in knowledge building and good quality content.

por SNEHA V

8 de ago de 2020

Its Completely Useful for students!! Keep going. Thank you!!

por Ansumita B

5 de mai de 2020

I liked the course it was awesome learning from this coursea

por David L

29 de out de 2019

Could do with an update. It's 6 years old, much has changed.

por Maria T

29 de mar de 2022

V​ery informative on clinical trials and industrial issues.

por Reem M A R

28 de jun de 2020

Great knowledge for steps of new drugs registration in FDA

por Yashwantsinh J

18 de jun de 2020

Good learning prospectives and very interesting sessions.

por Prateek K

1 de out de 2021

i​mmersive and insightful across the pharma value chain.

por CHANCHALA A

27 de jun de 2020

very useful to our knowledge happy to choose this course

por KONKEPUDI G M

15 de jun de 2020

VERY HELPFUL FOR THE STUDENTS IN PHARMACEUTICAL SCIENCES

por H C

6 de ago de 2017

I could understand about the process of drug development

por Mohammed M H C

18 de abr de 2020

Excellent course and enriched materials with clear view

por t. O

14 de mar de 2019

One of the best courses I ever took. Very informative.

por Arshad s

10 de mar de 2019

it is good to learn about new things in a different way

por Ahmed

21 de set de 2020

This has been a hard time but it was worth it . thanks

por DEVIS M M D P

17 de set de 2020

It teaches the kind of hidden part of drug development

por Nancy Z

1 de fev de 2021

Perfect balance of scientific and business knowledge.

por NALLIPOGU S T

29 de set de 2020

Is this a good platform to gain knowledge in COURSERA

por Talissa C M D B

28 de jul de 2020

Muito bom, apenas não consegui acessar o certificado

por anubhav t

12 de set de 2021

loved it... increased my understsanding of industry