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

4.7
étoiles
2,104 évaluations

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.

Thank you!

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351 - 375 sur 416 Avis pour Développement de médicaments

par Sifat U

•

8 nov. 2022

This course was really tough but I enjoyed it

par Rekhakumari C

•

17 août 2020

INFORMATIVE & GOO EXPERIENCE . THANKYOU..

par VIHAN S

•

21 juin 2020

Very informative and illustrative course

par Hesham E

•

26 mai 2020

Wonderful journey in drug lifecycle.

par VINEET A

•

14 mai 2021

It was very informational,

THANK YOU

par ABHIRAM P G

•

23 sept. 2021

very informative wrt formal aspect

par Rajan D

•

2 mai 2022

trials and their usage is great.

par ABHIJEET N

•

28 juil. 2020

need more elaborated lectures

par Kurre B

•

5 juil. 2020

Nice and very well explained

par MUSAIB Z

•

27 mai 2020

This course was very useful

par m_taisir k

•

16 sept. 2017

thanks ,it was interested

par Kiran

•

28 mai 2020

very useful to beginners

par Seema A G

•

22 avr. 2020

Very informative course.

par Himanshi

•

17 août 2020

very good experience

par Manda L p

•

4 juin 2020

very helpful course

par Janet T

•

17 oct. 2019

A great overview.

par Nilanjan P

•

30 nov. 2019

excellent course

par Sivanaga V M

•

23 nov. 2020

Good course

par Jakka B

•

28 août 2020

Informative

par Shivani

•

24 juil. 2020

It is good

par EARRA S

•

30 mai 2020

Use full

par Ahmed S

•

22 juil. 2022

Great!

par Dr. S U

•

24 août 2020

useful

par Rumana F H A

•

18 nov. 2022

good

par AMAN V

•

7 sept. 2020

good

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