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Drug Development

ОбзорПрограмма курсаЧасто задаваемые вопросыАвторыСтоимостьРейтинги и отзывы

ГлавнаяМедико-биологические наукиКлинические исследования

Drug Development

University of California, San Diego

Об этом курсе: 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.

Для кого этот курс: This class is for professionals and students interested in better understanding the process of drug development in the pharmaceutical and biotech industry as well as anyone who wants to learn how new drugs are developed after they received an IND. This part of the course will focus on the clinical development of new drugs up to the filing of an NDA.


Автор:  University of California, San Diego
University of California, San Diego

  • Williams S. Ettouati, Pharm.D.

    Преподаватели:  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

    Преподаватели:  Joseph D. Ma, Associate Professor of Clinical Pharmacy

    Skaggs School of Pharmacy and Pharmaceutical Sciences
УровеньBeginner
Выполнение3-4 hours/week
Язык
English
Как пройти курсЧтобы пройти курс, выполните все оцениваемые задания.
Оценки пользователей
4.4 звезды
Средняя оценка пользователей: 4.4Посмотрите, что пишут учащиеся
Программа курса
НЕДЕЛЯ 1
Welcome!
1 видео
  1. Видео: Welcome!
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.
5 видео, 2 материалов для самостоятельного изучения
  1. Видео: Regulatory Considerations When Filing an Investigational New Drug Application I
  2. Видео: Regulatory Considerations When Filing an Investigational New Drug Application II
  3. Discussion Prompt: How do high user fees impact drug development?
  4. Видео: Regulatory Considerations When Filing an Investigational New Drug Application III
  5. Видео: Regulatory Considerations When Filing an Investigational New Drug Application IV
  6. Видео: Regulatory Considerations When Filing an Investigational New Drug Application V
  7. Discussion Prompt: The FDA's impact on drug development?
  8. Discussion Prompt: Share interesting findings from ClinicalTrials.gov
  9. Reading: Lecture Slides
  10. Reading: A new Master Degree in Science in Drug Development & Product Management at UCSD
Оцениваемый: Regulatory Considerations When Filing an Investigational New Drug Application Quiz
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.
5 видео, 1 материал для самостоятельного изучения
  1. Видео: Clinical Study & Start-up Activities I
  2. Видео: Clinical Study & Start-up Activities II
  3. Видео: Clinical Study & Start-up Activities III
  4. Discussion Prompt: What do you think are the most important ethical concerns?
  5. Видео: Clinical Study & Start-up Activities IV
  6. Видео: Clinical Study & Start-up Activities V
  7. Reading: Lecture Slides
Оцениваемый: Clinical Study & Start-up Activities Quiz
НЕДЕЛЯ 2
Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.
This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer.
5 видео, 1 материал для самостоятельного изучения
  1. Видео: Clinical Trials: Phase 1 Part I
  2. Видео: Clinical Trials: Phase 1 Part II
  3. Видео: Clinical Trials: Phase 1 Part III
  4. Discussion Prompt: Other major safety Phase I situations?
  5. Видео: Clinical Trials: Phase 1 Part IV
  6. Видео: Clinical Trials: Phase 1 Part V
  7. Reading: Lecture Slides
Оцениваемый: Clinical Trials: Phase 1 Quiz
Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.
Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer
5 видео, 1 материал для самостоятельного изучения
  1. Видео: Clinical Trials: Phase 2 Part I
  2. Видео: Clinical Trials: Phase 2 Part II
  3. Видео: Clinical Trials: Phase 2 Part III
  4. Видео: Clinical Trials: Phase 2 Part IV
  5. Видео: Clinical Trials: Phase 2 Part IV
  6. Discussion Prompt: How do you see changing medical technology impacting Phase II studies?
  7. Reading: Lecture Slides
Оцениваемый: Clinical Trials: Phase 2 Quiz
НЕДЕЛЯ 3
Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.
5 видео, 1 материал для самостоятельного изучения
  1. Видео: Industry Considerations with Phase III Clinical Trials I
  2. Discussion Prompt: Share other globally influenced drug discoveries!
  3. Видео: Industry Considerations with Phase III Clinical Trials II
  4. Discussion Prompt: Share a collaboration story...
  5. Видео: Industry Considerations with Phase III Clinical Trials III
  6. Видео: Industry Considerations with Phase III Clinical Trials IV
  7. Видео: Industry Considerations with Phase III Clinical Trials V
  8. Discussion Prompt: What other values do you see in running studies in a variety of countries?
  9. Reading: Lecture Slides
Оцениваемый: Industry Considerations with Phase III Clinical Trials Quiz
New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.
6 видео, 1 материал для самостоятельного изучения
  1. Видео: New Drug Application, Filing, Product Labeling I
  2. Видео: New Drug Application, Filing, Product Labeling II
  3. Видео: New Drug Application, Filing, Product Labeling III
  4. Видео: New Drug Application, Filing, Product Labeling IV
  5. Discussion Prompt: Where do you get data on drugs?
  6. Видео: New Drug Application, Filing, Product Labeling V
  7. Discussion Prompt: Drug Promotion: Good or Bad?
  8. Видео: New Drug Application, Filing, Product Labeling VI
  9. Reading: Lecture Slides
Оцениваемый: New Drug Application, Filing, Product Labeling Quiz

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Авторы
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.
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Рейтинги и отзывы
Оценка 4.4 из 5 по 147 отзывам

EB

I would like to see more updated information (i.e. more information on biologicals), current presentation is a bit old (from 2008-2010?)

But it provides good general overview of the clinical development process.

VF

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.

HS

Provides a good overview on drug development phases and challenges. Some lecturers are from the industry which gives a practical feeling to the whole process.

BD

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.



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