Informações sobre o curso
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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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cursos 100% online

Comece imediatamente e aprenda em seu próprio cronograma.
Calendar

Prazos flexíveis

Redefinir os prazos de acordo com sua programação.
Beginner Level

Nível iniciante

Clock

Approx. 8 hours to complete

Sugerido: 3-4 hours/week...
Comment Dots

English

Legendas: English...

Habilidades que você terá

Clinical ResearchDrug DevelopmentClinical Trial DesignClinical Development
Globe

cursos 100% online

Comece imediatamente e aprenda em seu próprio cronograma.
Calendar

Prazos flexíveis

Redefinir os prazos de acordo com sua programação.
Beginner Level

Nível iniciante

Clock

Approx. 8 hours to complete

Sugerido: 3-4 hours/week...
Comment Dots

English

Legendas: English...

Programa - O que você aprenderá com este curso

Week
1
Clock
3 minutos para concluir

Welcome!

...
Reading
1 vídeos (Total de 3 min)
Video1 videos
Clock
1 horas para concluir

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....
Reading
5 vídeos (Total de 46 min), 2 leituras, 1 teste
Video5 videos
Regulatory Considerations When Filing an Investigational New Drug Application II11min
Regulatory Considerations When Filing an Investigational New Drug Application III9min
Regulatory Considerations When Filing an Investigational New Drug Application IV8min
Regulatory Considerations When Filing an Investigational New Drug Application V6min
Reading2 leituras
Lecture Slidesmin
A new Master Degree in Science in Drug Development & Product Management at UCSD10min
Quiz1 exercícios práticos
Regulatory Considerations When Filing an Investigational New Drug Application Quiz14min
Clock
1 horas para concluir

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....
Reading
5 vídeos (Total de 43 min), 1 leitura, 1 teste
Video5 videos
Clinical Study & Start-up Activities II10min
Clinical Study & Start-up Activities III6min
Clinical Study & Start-up Activities IV6min
Clinical Study & Start-up Activities V8min
Reading1 leituras
Lecture Slidesmin
Quiz1 exercícios práticos
Clinical Study & Start-up Activities Quiz14min
Week
2
Clock
1 horas para concluir

Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.

This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer....
Reading
5 vídeos (Total de 46 min), 1 leitura, 1 teste
Video5 videos
Clinical Trials: Phase 1 Part II10min
Clinical Trials: Phase 1 Part III12min
Clinical Trials: Phase 1 Part IV9min
Clinical Trials: Phase 1 Part V5min
Reading1 leituras
Lecture Slidesmin
Quiz1 exercícios práticos
Clinical Trials: Phase 1 Quiz12min
Clock
1 horas para concluir

Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.

Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer...
Reading
5 vídeos (Total de 47 min), 1 leitura, 1 teste
Video5 videos
Clinical Trials: Phase 2 Part II10min
Clinical Trials: Phase 2 Part III10min
Clinical Trials: Phase 2 Part IV10min
Clinical Trials: Phase 2 Part IV5min
Reading1 leituras
Lecture Slidesmin
Quiz1 exercícios práticos
Clinical Trials: Phase 2 Quiz10min
Week
3
Clock
1 horas para concluir

Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.

...
Reading
5 vídeos (Total de 44 min), 1 leitura, 1 teste
Video5 videos
Industry Considerations with Phase III Clinical Trials II10min
Industry Considerations with Phase III Clinical Trials III10min
Industry Considerations with Phase III Clinical Trials IV7min
Industry Considerations with Phase III Clinical Trials V4min
Reading1 leituras
Lecture Slidesmin
Quiz1 exercícios práticos
Industry Considerations with Phase III Clinical Trials Quiz14min
Clock
1 horas para concluir

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

...
Reading
6 vídeos (Total de 55 min), 1 leitura, 1 teste
Video6 videos
New Drug Application, Filing, Product Labeling II10min
New Drug Application, Filing, Product Labeling III8min
New Drug Application, Filing, Product Labeling IV8min
New Drug Application, Filing, Product Labeling V9min
New Drug Application, Filing, Product Labeling VI8min
Reading1 leituras
Lecture Slidesmin
Quiz1 exercícios práticos
New Drug Application, Filing, Product Labeling Quiz10min

Instrutores

Williams S. Ettouati, Pharm.D.

Director, Industrial Relations & Development; Health Sciences Associate Clinical Professor, N.S.
Skaggs School of Pharmacy and Pharmaceutical Sciences

Joseph D. Ma

Associate Professor of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences

Sobre University of California San Diego

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....

Perguntas Frequentes – FAQ

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