Chevron Left
Zurück zu Medikamentenentwicklung

Bewertung und Feedback des Lernenden für Medikamentenentwicklung von University of California San Diego

4.7
Sterne
2,117 Bewertungen

Über den Kurs

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....

Top-Bewertungen

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!

HG

15. Okt. 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.

Filtern nach:

151 - 175 von 421 Bewertungen für Medikamentenentwicklung

von NALLIPOGU S T

29. Sep. 2020

Is this a good platform to gain knowledge in COURSERA

von Talissa C M D B

28. Juli 2020

Muito bom, apenas não consegui acessar o certificado

von anubhav t

12. Sep. 2021

loved it... increased my understsanding of industry

von Bekezela B K

14. Feb. 2023

Insightful course, with knowledgeable instructors

von Yujiao M

7. Okt. 2022

Thanks to the lecturers for sharing experience!!

von KEERTHIKA s

17. Sep. 2020

Very interesting course. I am so happy. Thank you

von John A

2. Dez. 2020

the course is informative and easy to understand

von Pathak K J

29. Mai 2020

Good for learning and thank you for your support

von Mrs. P S A

14. Mai 2020

I loved to learning the drug development course.

von Samiya K

26. Jan. 2020

this course prooved to be really very beneficial

von Sneha B G

18. Mai 2020

Best Course to Learn Drug development process.

von Shivam d

1. Mai 2020

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

von Saloni k

16. Juli 2020

It was a very useful and knowledgeable course

von Dr H J

18. Mai 2020

It was a NICE EXPERIENCE AND LOTS OF LEARNING

von Mritunjoy b

9. Juli 2021

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

von ALISA C D

10. Aug. 2020

Very helpful. I got exactly what I expected.

von faryal f

1. Okt. 2019

it was very informative and i loved doing it

von SarathyVarman A

31. Juli 2021

best for basic learner in clinical research

von Jivesh G

24. Juni 2020

Such an interesting and informative course.

von SYEDA K F

15. Mai 2020

very nice effort by university of San Diego

von Beatrice M

15. Feb. 2017

Great Class. We need more of these courses.

von Abhishek P

20. Juni 2020

Best course to give wide view into drugs

von Noor F M I

7. Juni 2020

very beneficial class, easy to understand

von George W

12. Okt. 2020

very well organized and very informative

von Matías G

14. Mai 2020

Very good intrudction to all the trials