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

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401 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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301 - 325 von 400 Bewertungen für Medikamentenentwicklung

von Savind C

2. Juni 2021

T​he course should be updated. Most of the data presented is almost a decade old. Also, The person who teaches about Phase II trails is not clear, and it is hard to understand him.

von Mary S

14. Juli 2020

I would have loved to have a specific case study to follow as an example of how a drug goes through the whole life cycle as the course felt a bit too high-level overview at times.

von suzana

8. Nov. 2020

The course is well organized, but it requires an update of the contents.

It is good for starting and refreshing the topic of clinical trials. I look for the next updated one!

von Urjita J

1. Juni 2020

Very detailed and conceptually clear information. lectures are very well designed for online learning. Good distribution of the entire drug dev. procedure. Learnt a lot!

von Hussein S

14. Nov. 2017

Provides a good overview on drug development phases and challenges. Some lecturers are from the industry which gives a practical feeling to the whole process.

von Sebastian F

24. Jan. 2021

Very well presented, very interesting. As many already mentioned unfortunately the material and data is a little out of date. Nevertheless, very good course.

von Muhamed S E

13. Aug. 2017

Great Course , although i had some hardships understanding some parts and i had to search it online on my own ,, but overall i would recommend it !

von yousef e

28. Sep. 2019

i think you should put the speaker talking videos also in the lec not only the slides this will give more intent to complete the course faster

von Karen O

30. Juni 2020

Week 3 was the best! Both lecturers had loads of experience in industry, and shared all that knowledge with practical and real-life examples.

von Jahnavi

13. Okt. 2020

It is an amazing course that provides an practical insight into the field of clinical research. Thank you so much for your help and support.

von Álvaro S V

7. März 2019

This course gives a wide overview about clinical trials and all the process needed to launch a new drug. I really enjoyed it.

von Komal S

6. Juni 2020

Very informative content with lot of information about working of pharmaceutical companies during development of drugs.

von Murali D

9. Juli 2020

The course is very good and gives an overview on clinical studies phase-1 -4. I enjoyed the lectures in this course.

von Muhamad A B A B

8. Juli 2020

Quite difficult to grasp for a newbie. Presentation slides are a bit boring and at certain point, difficult to read.

von Sanjida R M

15. März 2021

This course is very informative . I have learnt in details about IND, IRB review, about drug commercialization.

von IRINA B B G

30. Juli 2019

Very easy to follow, fun, informal. Downside: speakers often talk in incomplete sentences, use inaudible terms.

von Claudia S

3. Okt. 2021

t​he course gives a good overview of the approval process of drug products, however it is a bit outdated

von B M T I

4. Juni 2020

This course was really helpful to me.It helps me to know many unknown things.It was really good.Thanks.

von N. F

19. Juni 2019

Very informative and useful course. Thank you very much to everyone who helped this work come to light

von Anand A

21. Juli 2020

very good information provided in this videos by eminent people Thanks for this who has provided it.

von James D

15. Jan. 2019

Great course, but some of the information is becoming outdated due to the course being from 2013

von Lavanya

25. Feb. 2020

Excellent course material could understand the entire scenario of clinical trial as a beginner

von Jan B

26. Feb. 2019

An interesting introduction. It is more of an overview than an actual course. Would do again.

von KONDAPAKA S

7. Mai 2020

happy to learn new things regarding the drug development . thqnks for this great opportunity

von Nadia C

30. Jan. 2020

some of the things was a little bit old - But i liked the content and the concepts