Drug Development
4.8 /5- Offered byCoursera
Drug Development at Coursera Overview
Duration | 10 hours |
Start from | Start Now |
Total fee | Free |
Mode of learning | Online |
Difficulty level | Beginner |
Official Website | Explore Free Course  |
Credential | Certificate |
Drug Development at Coursera Highlights
- 31% started a new career after completing these courses.
- Earn a shareable certificate upon completion.
- Flexible deadlines according to your schedule.
Drug Development at Coursera Course details
- 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.
Drug Development at Coursera Curriculum
Welcome!
Welcome!
Regulatory Considerations When Filing an Investigational New Drug Application I
Regulatory Considerations When Filing an Investigational New Drug Application II
Regulatory Considerations When Filing an Investigational New Drug Application III
Regulatory Considerations When Filing an Investigational New Drug Application IV
Regulatory Considerations When Filing an Investigational New Drug Application V
Lecture Slides
A new Master Degree in Science in Drug Development & Product Management at UCSD
Regulatory Considerations When Filing an Investigational New Drug Application Quiz
Clinical Study & Start-up Activities I
Clinical Study & Start-up Activities II
Clinical Study & Start-up Activities III
Clinical Study & Start-up Activities IV
Clinical Study & Start-up Activities V
Lecture Slides
Clinical Study & Start-up Activities Quiz
Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.
Clinical Trials: Phase 1 Part I
Clinical Trials: Phase 1 Part II
Clinical Trials: Phase 1 Part III
Clinical Trials: Phase 1 Part IV
Clinical Trials: Phase 1 Part V
Lecture Slides
Clinical Trials: Phase 1 Quiz
Clinical Trials: Phase 2 Part I
Clinical Trials: Phase 2 Part II
Clinical Trials: Phase 2 Part III
Clinical Trials: Phase 2 Part IV
Clinical Trials: Phase 2 Part IV
Lecture Slides
Clinical Trials: Phase 2 Quiz
Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.
Industry Considerations with Phase III Clinical Trials I
Industry Considerations with Phase III Clinical Trials II
Industry Considerations with Phase III Clinical Trials III
Industry Considerations with Phase III Clinical Trials IV
Industry Considerations with Phase III Clinical Trials V
Lecture Slides
Industry Considerations with Phase III Clinical Trials Quiz
New Drug Application, Filing, Product Labeling I
New Drug Application, Filing, Product Labeling II
New Drug Application, Filing, Product Labeling III
New Drug Application, Filing, Product Labeling IV
New Drug Application, Filing, Product Labeling V
New Drug Application, Filing, Product Labeling VI
Lecture Slides
New Drug Application, Filing, Product Labeling Quiz
Drug Development at Coursera Admission Process
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