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Drug Development

Approx. 10 hours to complete

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Course Summary

This course provides an overview of the drug development process, from discovery to marketing. Students will learn about the various stages of clinical trials, regulatory requirements, and challenges facing the pharmaceutical industry.

Key Learning Points

Understand the drug development process from discovery to marketing
Learn about the various stages of clinical trials and regulatory requirements
Gain insight into the challenges facing the pharmaceutical industry

Job Positions & Salaries of people who have taken this course might have

Clinical Research Associate
- USA: $67,000 - $123,000
- India: INR 4,00,000 - INR 10,00,000
- Spain: €24,000 - €40,000
Regulatory Affairs Specialist
- USA: $70,000 - $135,000
- India: INR 5,00,000 - INR 12,00,000
- Spain: €25,000 - €50,000
Pharmaceutical Sales Representative
- USA: $50,000 - $120,000
- India: INR 3,00,000 - INR 8,00,000
- Spain: €20,000 - €40,000

Learning Outcomes

Understand the drug development process and the role of clinical trials
Identify regulatory requirements for drug development and marketing
Evaluate challenges facing the pharmaceutical industry

Prerequisites or good to have knowledge before taking this course

Basic knowledge of biology and chemistry
Familiarity with clinical trial terminology

Course Difficulty Level

Intermediate

Course Format

Online
Self-paced

Similar Courses

Introduction to Clinical Data Science
Pharmacology: Understanding Drug Safety and Toxicity
Clinical Pharmacology

Related Education Paths

Related Books

Description

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.

Outline

Welcome!
Welcome!

Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.
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
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, Joseph Ma, Pharm.D.
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
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
Clinical Trials: Phase 1 Quiz

Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.
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
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
Industry Considerations with Phase III Clinical Trials Quiz

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

Summary of User Reviews

The drug development course on Coursera has received positive reviews from users. Many users found the course informative and engaging, providing a detailed overview of the drug development process.

Key Aspect Users Liked About This Course

The course provides a detailed overview of the drug development process.

Pros from User Reviews

Informative and engaging course content
Clear and concise explanations of complex concepts
Instructors with industry experience provide real-world insights
Good pacing of course material
Interactive assignments and quizzes help reinforce learning

Cons from User Reviews

Some users found the course material to be too basic
Limited coverage of certain drug development topics
Some technical issues with course platform
Lack of interaction with instructors
No opportunity for hands-on experience

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