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学生对 加州大学圣地亚哥分校 提供的 药物开发 的评价和反馈

4.7
1,843 个评分
387 条评论

课程概述

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....

热门审阅

HG
Oct 15, 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
May 24, 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!

筛选依据:

251 - 药物开发 的 275 个评论(共 385 个)

创建者 Dr M

Sep 16, 2020

nice

创建者 DIVYA S K

Sep 15, 2020

Nice

创建者 19BBT006-ANASWAR S B B B

Sep 12, 2020

Nice

创建者 Hrithikroshan

Sep 10, 2020

Good

创建者 GLORIYA V

Aug 24, 2020

Good

创建者 Uma M K

Jun 20, 2020

Good

创建者 Dhobi N

Jun 10, 2020

Good

创建者 sagiraju j s

Jun 10, 2020

good

创建者 yatam s r t

Jun 8, 2020

good

创建者 MASHETTY V

May 19, 2020

Good

创建者 sowjanya g

Mar 4, 2019

good

创建者 Mohammad j s

Sep 23, 2017

good

创建者 josephmary

Jun 18, 2020

yes

创建者 K V S R

May 24, 2020

yes

创建者 Nwando O

Feb 9, 2020

E

创建者 Sailaja B

Jul 10, 2019

N

创建者 Alan Q

May 17, 2018

E

创建者 Arman A

May 8, 2020

The course content is very good and the lecturers are highly knowledgeable in their fields. However, this course is a recording from a meeting (or conference) which is a bit distracting. People asking questions and two of the female lecturers were kind of laughing / joking a lot during this serious course. Also the one who was telling about FDA (in week one) was kind of saying "Oh, I don't know that.. I am not gonna talk about that.. You should have known.." This is a course and that's not I want hear from the lecturer. I felt that this meeting was not recorded for Coursera. It seems like someone said "Oh, we have the recording of this meeting and why not sell it on Coursera?". That's why I gave 4 stars.

创建者 ananda

May 4, 2021

Lots of good material despite covering a broad subject area. Phase 2 lecturer and content was the highlight for me. As was the case in the related Discovery course, the Development course content is primarily drawn from a series of guest lectures as opposed to content designed from the ground up specifically for this Coursera class. An unfortunate result is rushed and/or glossed over topics. For instance, the Phase 1 guest lecturer ran out of time and skipped several slides he was planning on covering. There was also a drop off in usefulness for me in terms of Phase 3 clinical design considerations and evaluations.

创建者 Valery T

May 27, 2018

Thisa course was very intersting to learn more about new drug application 2 years before applying to the FDA, the week 2 and 3 clinical trials and regulatory aspects were very interesting. The format of assessment can be like content of 3/4 page and then the individual selects an option as to what to do to rectify the information. That is a more efficient process to creatively think and do the regulations job in a real world scenario. I had no hesitation in doing this course and would do it again. Very useful for my background of medical technician and analytical chemistry degrees.

创建者 Venkat R R

Jun 25, 2020

The initial sections of the course was interesting like preclinical and clinical, but some improvements needed for the later part of the course like NDA and commercialization. Overall, the content of the course needs to be updated to reflect the current pharma development process in terms of drug spending; approval time and new FDA review pathways; no, of drugs approved by each review pathway; and latest therapeutic advancements happening and how FDA views them. Hope these points will be considered in improving the course learning relevant to the current times.

创建者 miranda w

Feb 18, 2020

I think the Course name should be changed - Drug Development - Clinical Trials through the phases.

It is super useful for people wanting to learn about clinical trials, it is mostly about clinical trials BUT the name of the course doesn't convey this, so a propospective employer in clinical trials wont care about this course because the name isnt informative enough about what you taught

创建者 Aedrian A

Jan 16, 2021

This course adequately introduced the issues and the reality of the drug development process through the several expert presenters. Being interested in this field as an outsider, I appreciate the level of detail shared in the course. However, similar to the first part of the Coursera Specialization where this course belongs, the material seems outdated as well.

创建者 Vanja T

Feb 22, 2018

Very good talks and presentations, amazing speakers, lots of interesting information, very valuable course.

But OLD - the course needs major renewal, with new data and new talks. Same for power point presentations: most of them are totally useless, hard to understand and follow and just do not look nice. Please prepare better presentations for the next course.

创建者 Brendan D

Oct 15, 2017

Overall the content was relevant to drug development and presented in an organized manner. The presenters seemed to have a wealth of experience in development. This was my first time using Coursera and I enjoyed being able to pick up where I left off. I was disappointed with the course transcriptions as there were many inaccuracies.