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

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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

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

SJ

Jul 31, 2020

It is really informative and nice to learn about such a vast and growing industry. The only complain I have is all the data was from 2012 which has now either been changed or updated.

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301 - Drug Development 的 325 个评论（共 482 个）

创建者 shekinah g

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Mar 23, 2021

Thank

创建者 Rafat H

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Oct 9, 2025

Best

创建者 Vineeth K K

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Aug 26, 2025

good

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Nov 8, 2024

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Nov 6, 2024

good

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Nov 3, 2024

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创建者 Thota s v v K

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Nov 3, 2024

nice

创建者 Suman M

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Oct 27, 2024

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Jul 28, 2024

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创建者 Ranjit K B

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Sep 30, 2023

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创建者 Basheer A N

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Sep 22, 2021

good

创建者 Sohel S

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Nov 10, 2020

good

创建者 Dr M

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Sep 15, 2020

nice

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Sep 15, 2020

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Sep 12, 2020

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Sep 10, 2020

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Aug 24, 2020

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Jun 20, 2020

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Jun 10, 2020

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Jun 9, 2020

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Jun 7, 2020

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创建者 MASHETTY V

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May 19, 2020

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创建者 sowjanya g

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Mar 4, 2019

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创建者 Mohammad J S

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Sep 23, 2017

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Nov 6, 2024

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