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Avis et commentaires pour d'étudiants pour Développement de médicaments par Université de Californie à San Diego

4.7
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1,824 évaluations
386 avis

À propos du cours

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....

Meilleurs avis

HG
15 oct. 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 mai 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 sur 384 Avis pour Développement de médicaments

par Joana d a R

21 mars 2021

I've really enjoined this course.

par Chanky M

18 août 2020

good course for a master students

par Bhagyashri B

21 oct. 2020

I learn something new nformative

par Erica K T

27 mars 2020

Very informative, easy to follow

par Prasun N

19 juin 2020

It was nice experience for me .

par Ashish S S

7 juin 2020

Awesome course its just amazing

par Akshay S S

2 juil. 2019

This course is really helpful.

par Samuel R .

12 juin 2020

Very usefull course thank you

par Moataz A A A

29 sept. 2019

excellent one and very useful

par Rakshaa K

6 sept. 2020

Very useful and interesting

par Raji L M

15 janv. 2020

Detail and an amazing course

par Tonia T

20 mai 2019

Well organized and relevant.

par Roshani S P

9 sept. 2020

best course study material.

par Saras H T

12 août 2020

it was very fruitful course

par Gaurav b

5 juin 2020

great and very informative

par Nanting N

11 mai 2020

I really enjoy this class!

par Ewmi H R

9 oct. 2020

A well structured course.

par prudhvi r

21 mai 2020

Easy way of understanding

par Methun P

10 août 2019

awesome course.i enjoyed.

par Tahir H

23 déc. 2019

It was a good experience

par RANTHU A

2 juil. 2020

giving more information

par Israel V V

22 juin 2020

I learned a lot, thanks

par Chintan B

26 août 2019

Very Informative course

par Pratik P

22 avr. 2020

Nc course it's useful

par RHIANE A C

1 oct. 2020

Knowledgeable course