课程信息
4.5
195 ratings
34 reviews
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....
Globe

100% 在线课程

立即开始,按照自己的计划学习。
Calendar

可灵活调整截止日期

根据您的日程表重置截止日期。
Beginner Level

初级

Clock

建议:3-4 hours/week

完成时间大约为8 小时
Comment Dots

English

字幕:English

您将获得的技能

Clinical ResearchDrug DevelopmentClinical Trial DesignClinical Development
Globe

100% 在线课程

立即开始,按照自己的计划学习。
Calendar

可灵活调整截止日期

根据您的日程表重置截止日期。
Beginner Level

初级

Clock

建议:3-4 hours/week

完成时间大约为8 小时
Comment Dots

English

字幕:English

教学大纲 - 您将从这门课程中学到什么

1

章节
Clock
完成时间为 3 分钟

Welcome!

...
Reading
1 个视频(共 3 分钟)
Video1 个视频
Welcome!3分钟
Clock
完成时间为 1 小时

Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.

This week we hear from Dr. Susan Trieu, who in her 12+ years in the industry has worked in regulatory affairs. Since then, Dr. Trieu has gone on to work in Industry at MedImpact as their Drug Information Pharmacist....
Reading
5 个视频(共 46 分钟), 2 个阅读材料, 1 个测验
Video5 个视频
Regulatory Considerations When Filing an Investigational New Drug Application II11分钟
Regulatory Considerations When Filing an Investigational New Drug Application III9分钟
Regulatory Considerations When Filing an Investigational New Drug Application IV8分钟
Regulatory Considerations When Filing an Investigational New Drug Application V6分钟
Reading2 个阅读材料
Lecture Slides分钟
A new Master Degree in Science in Drug Development & Product Management at UCSD10分钟
Quiz1 个练习
Regulatory Considerations When Filing an Investigational New Drug Application Quiz14分钟
Clock
完成时间为 1 小时

Clinical Study & Start-up Activities, Joseph Ma, Pharm.D.

This module is presented by Dr. Joseph Ma, Associate Professor in the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences....
Reading
5 个视频(共 43 分钟), 1 个阅读材料, 1 个测验
Video5 个视频
Clinical Study & Start-up Activities II10分钟
Clinical Study & Start-up Activities III6分钟
Clinical Study & Start-up Activities IV6分钟
Clinical Study & Start-up Activities V8分钟
Reading1 个阅读材料
Lecture Slides分钟
Quiz1 个练习
Clinical Study & Start-up Activities Quiz14分钟

2

章节
Clock
完成时间为 1 小时

Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.

This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer....
Reading
5 个视频(共 46 分钟), 1 个阅读材料, 1 个测验
Video5 个视频
Clinical Trials: Phase 1 Part II10分钟
Clinical Trials: Phase 1 Part III12分钟
Clinical Trials: Phase 1 Part IV9分钟
Clinical Trials: Phase 1 Part V5分钟
Reading1 个阅读材料
Lecture Slides分钟
Quiz1 个练习
Clinical Trials: Phase 1 Quiz12分钟
Clock
完成时间为 1 小时

Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.

Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer...
Reading
5 个视频(共 47 分钟), 1 个阅读材料, 1 个测验
Video5 个视频
Clinical Trials: Phase 2 Part II10分钟
Clinical Trials: Phase 2 Part III10分钟
Clinical Trials: Phase 2 Part IV10分钟
Clinical Trials: Phase 2 Part IV5分钟
Reading1 个阅读材料
Lecture Slides分钟
Quiz1 个练习
Clinical Trials: Phase 2 Quiz10分钟

3

章节
Clock
完成时间为 1 小时

Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.

...
Reading
5 个视频(共 44 分钟), 1 个阅读材料, 1 个测验
Video5 个视频
Industry Considerations with Phase III Clinical Trials II10分钟
Industry Considerations with Phase III Clinical Trials III10分钟
Industry Considerations with Phase III Clinical Trials IV7分钟
Industry Considerations with Phase III Clinical Trials V4分钟
Reading1 个阅读材料
Lecture Slides分钟
Quiz1 个练习
Industry Considerations with Phase III Clinical Trials Quiz14分钟
Clock
完成时间为 1 小时

New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.

...
Reading
6 个视频(共 55 分钟), 1 个阅读材料, 1 个测验
Video6 个视频
New Drug Application, Filing, Product Labeling II10分钟
New Drug Application, Filing, Product Labeling III8分钟
New Drug Application, Filing, Product Labeling IV8分钟
New Drug Application, Filing, Product Labeling V9分钟
New Drug Application, Filing, Product Labeling VI8分钟
Reading1 个阅读材料
Lecture Slides分钟
Quiz1 个练习
New Drug Application, Filing, Product Labeling Quiz10分钟

讲师

Williams S. Ettouati, Pharm.D.

Director, Industrial Relations & Development; Health Sciences Associate Clinical Professor, N.S.
Skaggs School of Pharmacy and Pharmaceutical Sciences

Joseph D. Ma

Associate Professor of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences

关于 University of California San Diego

UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 10 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom—life is their laboratory....

常见问题

  • Once you enroll for a Certificate, you’ll have access to all videos, quizzes, and programming assignments (if applicable). Peer review assignments can only be submitted and reviewed once your session has begun. If you choose to explore the course without purchasing, you may not be able to access certain assignments.

  • When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.

还有其他问题吗?请访问 学生帮助中心