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
2,402 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

MR

Jul 18, 2018

Information in the course is very practical. I come from basic biology background and now with this course I gained some real insights about how the clinical trails happen.

PR

Dec 1, 2018

Fantastic course, learned a lot of new things. Will go for the drug discovery course next. Consider including the presentations before the tests rather than afterwards

筛选依据：

276 - Drug Development 的 300 个评论（共 478 个）

创建者 Sourav M

•

Sep 21, 2018

Thank you.

创建者 Mohamed S T A A

•

Sep 5, 2017

Excellent.

创建者 CS M L

•

Nov 4, 2020

excellent

创建者 Alessandro G

•

Aug 30, 2020

excellent

创建者 Abhishek M J

•

Aug 1, 2020

Excellent

创建者 srinivas r b

•

Jul 25, 2020

Excellent

创建者 botta a d

•

Jul 23, 2020

Very good

创建者 PRIYA P

•

Jul 2, 2020

excellent

创建者 Akhil N A

•

May 30, 2020

Excellent

创建者 vinay y

•

Apr 24, 2019

very good

创建者 krishna c

•

Mar 3, 2019

Great...!

创建者 MOHSIN A K

•

Dec 27, 2023

worth it

创建者 Pereverzeva A

•

Mar 30, 2020

Отлично!

创建者 Abdulvohid P

•

Aug 18, 2024

perfect

创建者 Stines J

•

Aug 18, 2021

helpful

创建者 Dr. N F

•

May 12, 2020

awesome

创建者 DR S D

•

Jan 7, 2022

useful

创建者 E01203139-SHERLIN S T B B

•

Sep 26, 2020

Useful

创建者 Sowmiya N

•

Jun 10, 2020

cheers

创建者 BAALOUDJ O

•

Jun 2, 2020

THANKS

创建者 DEVENDRA B

•

Jan 4, 2022

good

创建者 shekinah g

•

Mar 23, 2021

Thank

创建者 Rafat H

•

Oct 9, 2025

Best

创建者 Vineeth K K

•

Aug 26, 2025

good