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

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403 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

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.

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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251 - 275 von 401 Bewertungen für Medikamentenentwicklung

von Anna P

30. März 2020

Отлично!

von stines j

18. Aug. 2021

helpful

von Dr. N F

12. Mai 2020

awesome

von DR S D

8. Jan. 2022

useful

von E01203139-SHERLIN S T B B

26. Sep. 2020

Useful

von Sowmiya N

10. Juni 2020

cheers

von BAALOUDJ O

2. Juni 2020

THANKS

von DEVENDRA B

4. Jan. 2022

​good

von shekinah g

23. März 2021

Thank

von Basheer A N

22. Sep. 2021

good

von Sohel S

10. Nov. 2020

good

von Dr M

16. Sep. 2020

nice

von DIVYA S K

15. Sep. 2020

Nice

von 19BBT006-ANASWAR S B B B

12. Sep. 2020

Nice

von Hrithikroshan

10. Sep. 2020

Good

von GLORIYA V

24. Aug. 2020

Good

von Uma M K

20. Juni 2020

Good

von Dhobi N

10. Juni 2020

Good

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10. Juni 2020

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von yatam s r t

8. Juni 2020

good

von MASHETTY V

19. Mai 2020

Good

von sowjanya g

4. März 2019

good

von Mohammad j s

23. Sep. 2017

good

von josephmary

18. Juni 2020

yes

von K V S R

24. Mai 2020

yes