Chevron Left
Retour à Développement de médicaments

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

4.7
étoiles
1,820 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!

Filtrer par :

201 - 225 sur 384 Avis pour Développement de médicaments

par ankita p

17 sept. 2021

informative course

par Akilesh

13 juin 2020

Very useful course

par Magdoline N N

9 oct. 2019

Very useful course

par Raghad K

20 août 2021

v​ery informative

par Rodney T

26 mars 2021

Very good course.

par Sarah s

19 nov. 2020

Veryy nice course

par Melody F

19 juil. 2020

Excellent course!

par J P V

26 mai 2020

nice course .....

par Aula

6 janv. 2020

Thank you so much

par Sanchit V

17 mai 2020

excellent course

par Yuvashini E

10 janv. 2020

was very helpful

par Gozde I A

2 sept. 2019

Very informative

par SAMEER A

25 juil. 2018

EXCELLENT COURSE

par Anthony E J T

26 juil. 2020

Muy informativo

par julio r l

5 mai 2020

I

t

r

e

a

l

l

y

h

e

l

p

s

m

e

par Shikha K

7 juin 2020

great learning

par Leah F

9 avr. 2020

so interesting

par Andrey K

9 août 2021

Great course!

par Mehedi H R 1

29 août 2020

Great course.

par S.Nandha k

12 juin 2020

Useful course

par Anirudha D

28 juin 2021

Very helpful

par Jonathan M

1 déc. 2020

Excellent!!!

par MRS. S

25 août 2020

Very helpful

par Rafael V

12 juil. 2020

Great Course

par parikshith s d

31 août 2020

magnifisant