Drug Development

Location type
Logo Coursera
Provider rating: starstarstarstar_borderstar_border 6.3 Coursera has an average rating of 6.3 (out of 4 reviews)

Need more information? Get more details on the site of the provider.

Description

When you enroll for courses through Coursera you get to choose for a paid plan or for a free plan

  • Free plan: No certicification and/or audit only. You will have access to all course materials except graded items.
  • Paid plan: Commit to earning a Certificate—it's a trusted, shareable way to showcase your new skills.

About this course: 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…

Read the complete description

Frequently asked questions

There are no frequently asked questions yet. Send an Email to info@springest.com

Didn't find what you were looking for? See also: Pharma, Product Design, Change Management, Project Management, and Perl.

When you enroll for courses through Coursera you get to choose for a paid plan or for a free plan

  • Free plan: No certicification and/or audit only. You will have access to all course materials except graded items.
  • Paid plan: Commit to earning a Certificate—it's a trusted, shareable way to showcase your new skills.

About this course: 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.

Who is this class for: 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.

Created by:  University of California, San Diego
  • Taught by:  Williams S. Ettouati, Pharm.D., Director, Industrial Relations & Development; Health Sciences Associate Clinical Professor, N.S.

    Skaggs School of Pharmacy and Pharmaceutical Sciences
  • Taught by:  Joseph D. Ma, Associate Professor of Clinical Pharmacy

    Skaggs School of Pharmacy and Pharmaceutical Sciences
Level Beginner Commitment 3-4 hours/week Language English How To Pass Pass all graded assignments to complete the course. User Ratings 4.5 stars Average User Rating 4.5See what learners said Coursework

Each course is like an interactive textbook, featuring pre-recorded videos, quizzes and projects.

Help from your peers

Connect with thousands of other learners and debate ideas, discuss course material, and get help mastering concepts.

Certificates

Earn official recognition for your work, and share your success with friends, colleagues, and employers.

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.

Syllabus


WEEK 1


Welcome!



1 video expand


  1. Video: 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 videos, 2 readings expand


  1. Video: Regulatory Considerations When Filing an Investigational New Drug Application I
  2. Video: Regulatory Considerations When Filing an Investigational New Drug Application II
  3. Discussion Prompt: How do high user fees impact drug development?
  4. Video: Regulatory Considerations When Filing an Investigational New Drug Application III
  5. Video: Regulatory Considerations When Filing an Investigational New Drug Application IV
  6. Video: 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

Graded: 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 videos, 1 reading expand


  1. Video: Clinical Study & Start-up Activities I
  2. Video: Clinical Study & Start-up Activities II
  3. Video: Clinical Study & Start-up Activities III
  4. Discussion Prompt: What do you think are the most important ethical concerns?
  5. Video: Clinical Study & Start-up Activities IV
  6. Video: Clinical Study & Start-up Activities V
  7. Reading: Lecture Slides

Graded: Clinical Study & Start-up Activities Quiz

WEEK 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 videos, 1 reading expand


  1. Video: Clinical Trials: Phase 1 Part I
  2. Video: Clinical Trials: Phase 1 Part II
  3. Video: Clinical Trials: Phase 1 Part III
  4. Discussion Prompt: Other major safety Phase I situations?
  5. Video: Clinical Trials: Phase 1 Part IV
  6. Video: Clinical Trials: Phase 1 Part V
  7. Reading: Lecture Slides

Graded: 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 videos, 1 reading expand


  1. Video: Clinical Trials: Phase 2 Part I
  2. Video: Clinical Trials: Phase 2 Part II
  3. Video: Clinical Trials: Phase 2 Part III
  4. Video: Clinical Trials: Phase 2 Part IV
  5. Video: Clinical Trials: Phase 2 Part IV
  6. Discussion Prompt: How do you see changing medical technology impacting Phase II studies?
  7. Reading: Lecture Slides

Graded: Clinical Trials: Phase 2 Quiz

WEEK 3


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



5 videos, 1 reading expand


  1. Video: Industry Considerations with Phase III Clinical Trials I
  2. Discussion Prompt: Share other globally influenced drug discoveries!
  3. Video: Industry Considerations with Phase III Clinical Trials II
  4. Discussion Prompt: Share a collaboration story...
  5. Video: Industry Considerations with Phase III Clinical Trials III
  6. Video: Industry Considerations with Phase III Clinical Trials IV
  7. Video: 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

Graded: Industry Considerations with Phase III Clinical Trials Quiz

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



6 videos, 1 reading expand


  1. Video: New Drug Application, Filing, Product Labeling I
  2. Video: New Drug Application, Filing, Product Labeling II
  3. Video: New Drug Application, Filing, Product Labeling III
  4. Video: New Drug Application, Filing, Product Labeling IV
  5. Discussion Prompt: Where do you get data on drugs?
  6. Video: New Drug Application, Filing, Product Labeling V
  7. Discussion Prompt: Drug Promotion: Good or Bad?
  8. Video: New Drug Application, Filing, Product Labeling VI
  9. Reading: Lecture Slides

Graded: New Drug Application, Filing, Product Labeling Quiz
There are no reviews yet.

Share your review

Do you have experience with this course? Submit your review and help other people make the right choice. As a thank you for your effort we will donate $1.- to Stichting Edukans.

There are no frequently asked questions yet. Send an Email to info@springest.com