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.
SJ
It is really informative and nice to learn about such a vast and growing industry. The only complain I have is all the data was from 2012 which has now either been changed or updated.
SK
I am really glad to have course offered by california university . Its really helpful for me. And i am thankful to all lecturer, and teachers to explain overall drug development process. Thank you!
SC
The course should be updated. Most of the data presented is almost a decade old. Also, The person who teaches about Phase II trails is not clear, and it is hard to understand him.
NV
Thank you very much for covering all Phases of clinical trial. Very useful and informative. Thank you for providing me with the financial aid to complete this course.
MT
Clinical trial are most important part of pharma sector for drug development and development of a molecule It's important to all of us whose involved in research and development Thank you!!!
SO
Great course for learning the basics of the drug development process from clinical trials to filling marketing and post-marketing commitments. Great place to start!
VP
The course was informative and found exactly at the time of need. I was a little disappointed because it's not the latest updated version. looking forward to the updated version of the course.
MR
Information in the course is very practical. I come from basic biology background and now with this course I gained some real insights about how the clinical trails happen.
HD
Great introduction to the nuances of drug development, post research and into clinical and commercial aspects. I feel much more ready to enter the regulatory affairs arena after this.
PR
Fantastic course, learned a lot of new things. Will go for the drug discovery course next. Consider including the presentations before the tests rather than afterwards
NP
Comprehensive review of all phases of drug development from IND to NDA and post-approval.. thoroughly enjoyed the lectures on phase I & II study design and interpretation!
MS
I would have loved to have a specific case study to follow as an example of how a drug goes through the whole life cycle as the course felt a bit too high-level overview at times.
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course material is very old. from 2013. I would highly recommend to update the study material. it was very disappointing that I was not able to get the picture of current drug development
Extremely outdated, this course was recorded in 2013 and has not been updated. I have paid money to get a certificate on outdated information. Furthermore, this course is very low effort and half-arsed. Simple recordings with bad quality audio of lectures given to actual students (which means you hear muffled voices of students asking questions, at one point even a car alarm). Inexperienced speakers who were clearly nervous. The videos cut odd and unlogical places, moreover, they don't seem complete, not consistent with the slides given at the end of the week. I'd like to see an actual well-prepared course adapted for online viewing.
this course is really very informative especially for those who are new to this field and even those who are experienced. I highly recommend to attend this great program
The phases are covered in a haphazardly manner. The last section on commercialization is just terrible. The two lecturers joked and laughed among themselves more than teaching anything. Not worth being a paid for course. Would've been a hundred times better to take a free course.
Drug Development course is an Informative and Innovative and Help full for Development of the drug after Discovering it, and Kind Request to provide the Intermediate level and Advanced level courses.
I thought this course was done very well. The lectures were extremely informative and easy to follow. They connected very well with the audience. I would recommend this course to others...and I will.
Seems to be based on lectures and data available at the time of 2013, so this course is getting a little bit dated now in 2019. Interesting and informative none the less.
The course is very informative, specially for people with no experience nor specialized formation in Clinical Trials. However, it is not very detailed nor demanding, so I doubt about its usefulness for someone with previous university formation in clinical research field.
Fantastic course, learned a lot of new things. Will go for the drug discovery course next. Consider including the presentations before the tests rather than afterwards
I am new to the pharmaceutical field (less than 2 years) and found this course extremely helpful in that it gave me a much more clear and detailed picture of the drug development process as a whole, and provided more formal training to complement the knowledge I have gained on-the-job. I found the instructors' lessons easy to follow for the most part, although from a beginner's standpoint (BS in biology with 2 years experience in pharma), the second half of week 2 of this course got a little confusing at times. I would have appreciated some sort of "office hours" where we could post questions and have the chance to maybe hear responses to the most popular questions from the instructors. Overall I would definitely recommend this course if you're interested in or just getting started in pharma.
Great course, came up with drug concentration based on half life and also on electronic mental disorder measure based on interview and then direct concentration dose reComendation hypothesis and also thought of non selective cancer cure based on valorproic acid as it suppressed genes and it's expression and division. Also wrote a paper on IQ and jruri muscular strength based on threshold and firing and correlation to neuro schedule H medicine. extremeadventureinc.business.site
My only comment is minor - I like to print the slides and make notes on them as I listen to each lecture. I have used so much ink up printing them due to them having blue backgrounds etc. It would be good for future courses that the slides can be made just in black and white with minimal use of colour.
Excellent! I am rather new in the Drug Development field, this course really helped me onboard and catch up with terminology and a lot of commonly encountered acronyms (IND, NDA etc..) Would highly recommend to those who are new in the field or just want to broaden their knowledge.
This course so effective as a beginner life science student in the drug discovery which is innovative sector in the world for safety of human being . So i am very glad that easily i achieved knowledge from this organization. so thanks to all who are affiliated of this program.
Very well done and informative. I truly appreciate the Drug process in entirety being broken down into sections that are easy to comprehend. It is obvious the speakers were chosen for their knowledge.
The material in general is quite usefull and convenience, well explained videos and the slides abailable is an adavantage, but the major problem is that the information is out-of-date. The information and exaples are from 2013 or even before that date. I would have liked a more accurate vision of the actual pharmaceutical data.
Compare to other courses like python for everybody, this lecture is too boring, all they did was, they kept on reading the slides
It was really a great self pace learning course of drug discovery.I learnt so many different terminologies and concepts which were not covered in my academic syllabus.Thank you Cousera for providing us such a great platform and i am also thankful for Financial assistance.
The session was good and interesting, which is like a refreshment of my knowledge .However the data that was in the slides/vidoes we not updated. The data was 2012 and 2013, which could have been updated atleast till 2019, becuse there could hve been many updates in FDA
indeed it's very helpful, from highly experienced tutors who put their decades of experience in just few hours for you, now i will be greedy and we want that course from the aspect or FDA perspective. how the files and documents are assessed and reviewed.