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Drug Development
  • Level Foundation
  • المدة 10 ساعات hours
  • الطبع بواسطة University of California San Diego
  • Offered by

عن

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, Drug Development and 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.

الوحدات

Lesson 1

    • 1 Videos
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1 Videos

  • Welcome!

Regulatory Considerations When Filing an Investigational New Drug Application Part I

    • 2 Videos
    • 1 Discussion
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1 Discussions

  • How do high user fees impact drug development?

2 Videos

  • 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 Part II

    • 3 Videos
    • 1 Discussion
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1 Discussions

  • The FDA's impact on drug development?

3 Videos

  • 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

Review

    • 1 Readings
    • 1 Discussion
    • 1 Assignment
Show info about module content

1 Assignment

  • Regulatory Considerations When Filing an Investigational New Drug Application Quiz

1 Discussions

  • Share interesting findings from ClinicalTrials.gov

1 Readings

  • Lecture Slides

Optional Materials

    • 1 Readings
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1 Readings

  • A new Master Degree in Science in Drug Development & Product Management at UCSD

Clinical Study & Start-up Activities Part I

    • 2 Videos
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2 Videos

  • Clinical Study & Start-up Activities I
  • Clinical Study & Start-up Activities II

Clinical Study & Start-up Activities Part II

    • 3 Videos
    • 1 Discussion
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1 Discussions

  • What do you think are the most important ethical concerns?

3 Videos

  • Clinical Study & Start-up Activities III
  • Clinical Study & Start-up Activities IV
  • Clinical Study & Start-up Activities V

Review

    • 1 Readings
    • 1 Assignment
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1 Assignment

  • Clinical Study & Start-up Activities Quiz

1 Readings

  • Lecture Slides

Clinical Trials: Phase 1 Part I

    • 2 Videos
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2 Videos

  • Clinical Trials: Phase 1 Part I
  • Clinical Trials: Phase 1 Part II

Clinical Trials: Phase 1 Part II

    • 3 Videos
    • 1 Discussion
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1 Discussions

  • Other major safety Phase I situations?

3 Videos

  • Clinical Trials: Phase 1 Part III
  • Clinical Trials: Phase 1 Part IV
  • Clinical Trials: Phase 1 Part V

Review

    • 1 Readings
    • 1 Assignment
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1 Assignment

  • Clinical Trials: Phase 1 Quiz

1 Readings

  • Lecture Slides

Clinical Trials: Phase 2 Part I

    • 2 Videos
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2 Videos

  • Clinical Trials: Phase 2 Part I
  • Clinical Trials: Phase 2 Part II

Clinical Trials: Phase 2 Part II

    • 3 Videos
    • 1 Discussion
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1 Discussions

  • How do you see changing medical technology impacting Phase II studies?

3 Videos

  • Clinical Trials: Phase 2 Part III
  • Clinical Trials: Phase 2 Part IV
  • Clinical Trials: Phase 2 Part IV

Review

    • 1 Readings
    • 1 Assignment
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1 Assignment

  • Clinical Trials: Phase 2 Quiz

1 Readings

  • Lecture Slides

Industry Considerations with Phase III Clinical Trials Part I

    • 2 Videos
    • 2 Discussion
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2 Discussions

  • Share other globally influenced drug discoveries!
  • Share a collaboration story...

2 Videos

  • Industry Considerations with Phase III Clinical Trials I
  • Industry Considerations with Phase III Clinical Trials II

Industry Considerations with Phase III Clinical Trials Part II

    • 3 Videos
    • 1 Discussion
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1 Discussions

  • What other values do you see in running studies in a variety of countries?

3 Videos

  • Industry Considerations with Phase III Clinical Trials III
  • Industry Considerations with Phase III Clinical Trials IV
  • Industry Considerations with Phase III Clinical Trials V

Review

    • 1 Readings
    • 1 Assignment
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1 Assignment

  • Industry Considerations with Phase III Clinical Trials Quiz

1 Readings

  • Lecture Slides

New Drug Application, Filing, Product Labeling Part I

    • 3 Videos
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3 Videos

  • 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 Part II

    • 3 Videos
    • 2 Discussion
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2 Discussions

  • Where do you get data on drugs?
  • Drug Promotion: Good or Bad?

3 Videos

  • New Drug Application, Filing, Product Labeling IV
  • New Drug Application, Filing, Product Labeling V
  • New Drug Application, Filing, Product Labeling VI

Review

    • 1 Readings
    • 1 Assignment
Show info about module content

1 Assignment

  • New Drug Application, Filing, Product Labeling Quiz

1 Readings

  • Lecture Slides

Auto Summary

Explore the comprehensive "Drug Development" course from UC San Diego's Skaggs School of Pharmacy, featuring insights from top faculty and industry experts. This engaging course covers the entire clinical development process, from early-stage trials to regulatory approvals. Ideal for science and engineering enthusiasts, the course includes detailed lectures on IND and NDA applications, study design methods, and phases of clinical trials. With a 600-minute duration and various subscription options, this foundational course is perfect for those looking to deepen their understanding of drug development.

Williams S. Ettouati, Pharm.D.
Instructors

Williams S. Ettouati, Pharm.D.

Joseph D. Ma
Instructors

Joseph D. Ma