Chevron Left
医薬品開発 に戻る

カリフォルニア大学サンディエゴ校 による 医薬品開発 の受講者のレビューおよびフィードバック

4.7
1,999件の評価

コースについて

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....

人気のレビュー

HG

2018年10月15日

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.

KR

2020年5月24日

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!

フィルター:

医薬品開発: 126 - 150 / 405 レビュー

by Felipe R F

2020年1月19日

Very good content. Could go more in depth of the studies designs

by Imani

2020年7月31日

I truly enjoyed taking this course. It was beyond a refresher!

by Rohan M

2020年4月23日

very informative and good teachers.....gained some knowledge...

by Penugonda V L D S S

2020年5月28日

very useful and informative....thanks a lot to the instructors

by Chinmay P

2020年7月29日

Easy to learn with goof knowledge and just perfect time span.

by Sahil K

2020年8月14日

Very helpful in knowledge building and good quality content.

by SNEHA V

2020年8月8日

Its Completely Useful for students!! Keep going. Thank you!!

by Ansumita B

2020年5月5日

I liked the course it was awesome learning from this coursea

by David L

2019年10月29日

Could do with an update. It's 6 years old, much has changed.

by Maria T

2022年3月29日

V​ery informative on clinical trials and industrial issues.

by Reem M A R

2020年6月28日

Great knowledge for steps of new drugs registration in FDA

by Yashwantsinh J

2020年6月18日

Good learning prospectives and very interesting sessions.

by Prateek K

2021年10月1日

i​mmersive and insightful across the pharma value chain.

by CHANCHALA A

2020年6月27日

very useful to our knowledge happy to choose this course

by KONKEPUDI G M

2020年6月15日

VERY HELPFUL FOR THE STUDENTS IN PHARMACEUTICAL SCIENCES

by H C

2017年8月6日

I could understand about the process of drug development

by Mohammed M H C

2020年4月18日

Excellent course and enriched materials with clear view

by t. O

2019年3月14日

One of the best courses I ever took. Very informative.

by Arshad s

2019年3月10日

it is good to learn about new things in a different way

by Ahmed

2020年9月21日

This has been a hard time but it was worth it . thanks

by DEVIS M M D P

2020年9月17日

It teaches the kind of hidden part of drug development

by Nancy Z

2021年2月1日

Perfect balance of scientific and business knowledge.

by NALLIPOGU S T

2020年9月29日

Is this a good platform to gain knowledge in COURSERA

by Talissa C M D B

2020年7月28日

Muito bom, apenas não consegui acessar o certificado

by anubhav t

2021年9月12日

loved it... increased my understsanding of industry