Drug Development
date_range Débute le 27 mars 2017
event_note Se termine le 17 avril 2017
list 3 séquences
assignment Niveau : Introductif
label Physique, Chimie et Biologie
chat_bubble_outline Langue : Anglais
card_giftcard 5.4 points
3.4 /5
Avis de la communauté
9 avis

Les infos clés

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timer 9 heures de cours

En résumé

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.

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Le programme

  • Week 1 - Welcome!
     
  • Week 1 - Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.
    This week we hear from Dr. Susan Trieu, who in her 12+ years in the industry has worked in regulatory affairs. Since then, Dr. Trieu has gone on to work in Industry at MedImpact as their Drug Information Pharmacist.
  • Week 1 - Clinical Study & Start-up Activities, Joseph Ma, Pharm.D.
    This module is presented by Dr. Joseph Ma, Associate Professor in the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences.
  • Week 2 - Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.
    This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer.
  • Week 2 - Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.
    Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer
  • Week 3 - Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.
     
  • Week 3 - New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.
     
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Le concepteur

UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 10 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom—life is their laboratory.
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La plateforme

Coursera est une entreprise numérique proposant des formation en ligne ouverte à tous fondée par les professeurs d'informatique Andrew Ng et Daphne Koller de l'université Stanford, située à Mountain View, Californie.

Ce qui la différencie le plus des autres plateformes MOOC, c'est qu'elle travaille qu'avec les meilleures universités et organisations mondiales et diffuse leurs contenus sur le web.

Avis de la communauté
3.4 /5 Moyenne
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3.4/5
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3.4/5
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3.4/5
Le meilleur avis

Very good talks and presentations, amazing speakers, lots of interesting information, very valuable course. But OLD - the course needs major renewal, with new data and new talks. Same for power point presentations: most of them are totally useless, hard to understand and follow and just do not look nice. Please prepare better presentations for the next course.

le 22 février 2018
Quelle note donnez-vous à cette ressource ?
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le 26 février 2018

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.

le 22 février 2018

Very good talks and presentations, amazing speakers, lots of interesting information, very valuable course. But OLD - the course needs major renewal, with new data and new talks. Same for power point presentations: most of them are totally useless, hard to understand and follow and just do not look nice. Please prepare better presentations for the next course.

le 20 février 2018

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

le 14 novembre 2017

Provides a good overview on drug development phases and challenges. Some lecturers are from the industry which gives a practical feeling to the whole process.

le 15 octobre 2017

Overall the content was relevant to drug development and presented in an organized manner. The presenters seemed to have a wealth of experience in development. This was my first time using Coursera and I enjoyed being able to pick up where I left off. I was disappointed with the course transcriptions as there were many inaccuracies.