Drug Development
Drug Development Product Management,
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.
Get a Reminder
Rating | 4.4★ based on 106 ratings |
---|---|
Length | 4 weeks |
Effort | 3-4 hours/week |
Starts | Jul 10 (41 weeks ago) |
Cost | $59 |
From | University of California San Diego via Coursera |
Instructors | Joseph D. Ma, Williams S. Ettouati, Pharm.D. |
Download Videos | On all desktop and mobile devices |
Language | English |
Subjects | Science |
Tags | Life Sciences Clinical Science Research |
Get a Reminder
Similar Courses
What people are saying
drug development process
Thank you very much to everyone who helped this work come to light Great course for learning the basics of the drug development process from clinical trials to filling marketing and post-marketing commitments.
Was a very informative course, gave me an overview of entire drug development process.
Read more
about clinical trials
it is good to learn about new things in a different way This course gives a wide overview about clinical trials and all the process needed to launch a new drug.
I think the Course name should be changed - Drug Development - Clinical Trials through the phases.It is super useful for people wanting to learn about clinical trials, it is mostly about clinical trials BUT the name of the course doesn't convey this, so a propospective employer in clinical trials wont care about this course because the name isnt informative enough about what you taught I find the course to be extremely informative due to the fact that actual industrial people have handled the drug development course.
highly recommend
I would highly recommend to update the study material.
I highly recommend to attend this great program Great course, but some of the information is becoming outdated due to the course being from 2013 Fantastic course, learned a lot of new things.
Highly recommended, very insightful and gives a broad overview of Drug development.
Read more
very useful
Very useful for my background of medical technician and analytical chemistry degrees.
cannot wait to go to the third course a Drug commercialization Very useful course excellent it was very informative and i loved doing it excellent one and very useful i think you should put the speaker talking videos also in the lec not only the slides this will give more intent to complete the course faster Thank you very much for covering all Phases of clinical trial.
Read more
truly enjoyed
I truly enjoyed the lecture content and am thankful for the course.
I found the lecture material of the others speakers better organized I truly enjoyed taking this course.
Read more
Careers
An overview of related careers and their average salaries in the US. Bars indicate income percentile.
Drug & Crisis Counselor $41k
Drug Analyst $60k
Drug Enforcement Administration $64k
Drug Information Analyst $71k
Drug safety evaluator $78k
Drug Development Analyst $80k
Drug Wholesale Administrator $81k
Research Scientist, Drug Discovery & Development $90k
Scientist, Drug Product Development Large Molecule $94k
Head of Drug Safety $101k
Drug Delivery Marketing Manager; Manager of Commercial Development $102k
Senior Facilites Mechanic Drug Substance/Drug Product $119k
Write a review
Your opinion matters. Tell us what you think.
Please login to leave a review
Rating | 4.4★ based on 106 ratings |
---|---|
Length | 4 weeks |
Effort | 3-4 hours/week |
Starts | Jul 10 (41 weeks ago) |
Cost | $59 |
From | University of California San Diego via Coursera |
Instructors | Joseph D. Ma, Williams S. Ettouati, Pharm.D. |
Download Videos | On all desktop and mobile devices |
Language | English |
Subjects | Science |
Tags | Life Sciences Clinical Science Research |
Similar Courses
Sorted by relevance
Like this course?
Here's what to do next:
- Save this course for later
- Get more details from the course provider
- Enroll in this course