Chevron Left
返回到 Drug Development

学生对 University of California San Diego 提供的 Drug Development 的评价和反馈

4.7
星
2,427 个评分

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://hua.dididi.sbs/learn/drug-discovery), Drug Development and Drug Commercialization (https://hua.dididi.sbs/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

SK

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. Thank you!

NV

Sep 25, 2019

Thank you very much for covering all Phases of clinical trial. Very useful and informative. Thank you for providing me with the financial aid to complete this course.

筛选依据：

401 - Drug Development 的 425 个评论（共 486 个）

创建者 Rosilin S A f

•

Oct 30, 2024

Its, becoming more interesting and interesting to learn.

创建者 Matthew K

•

Aug 3, 2017

Good primer on Drug Development albeit very high level.

创建者 Avishek S

•

Aug 27, 2020

It can be more arranged and in detail.

but pretty good.

创建者 Alex

•

Apr 25, 2019

A very interesting lecture on drug development stages.

创建者 Mahesh W

•

Feb 21, 2022

I know deeply the details of phases clinical trials

创建者 Deepak R

•

Jul 15, 2023

Week 2 seems to be more technical than the others.

创建者 ABHISHEK S

•

Nov 5, 2020

An amazing way to learn drug development studies.

创建者 Paul C

•

Mar 2, 2017

Brilliant framework and well designed structure

创建者 Sifat U

•

Nov 8, 2022

This course was really tough but I enjoyed it

创建者 Rekhakumari C

•

Aug 17, 2020

INFORMATIVE & GOO EXPERIENCE . THANKYOU..

创建者 VIHAN S

•

Jun 21, 2020

Very informative and illustrative course

创建者 Hesham E

•

May 26, 2020

Wonderful journey in drug lifecycle.

创建者 Vineet A

•

May 14, 2021

It was very informational,

THANK YOU

创建者 ABHIRAM P G

•

Sep 23, 2021

very informative wrt formal aspect

创建者 Rajan D

•

May 2, 2022

trials and their usage is great.

创建者 ABHIJEET N

•

Jul 28, 2020

need more elaborated lectures

创建者 Kurre B

•

Jul 5, 2020

Nice and very well explained

创建者 MUSAIB Z

•

May 27, 2020

This course was very useful

创建者 Mohsen C

•

Jun 10, 2024

Don't lose the week three!

创建者 m_taisir k

•

Sep 16, 2017

thanks ,it was interested

创建者 Kiran

•

May 28, 2020

very useful to beginners

创建者 Seema A G

•

Apr 22, 2020

Very informative course.

创建者 Himanshi

•

Aug 16, 2020

very good experience

创建者 Manda L p

•

Jun 4, 2020

very helpful course

创建者 Janet T

•

Oct 17, 2019

A great overview.