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약물 개발(으)로 돌아가기

캘리포니아 샌디에고 대학교의 약물 개발 학습자 리뷰 및 피드백

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1,977개의 평가
403개의 리뷰

강좌 소개

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....

최상위 리뷰

KR

2020년 5월 24일

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.\n\nThank you!

HG

2018년 10월 15일

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.

필터링 기준:

약물 개발의 401개 리뷰 중 126~150

교육 기관: Felipe R F

2020년 1월 19일

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

교육 기관: Imani

2020년 7월 31일

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

교육 기관: Rohan M

2020년 4월 23일

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

교육 기관: Penugonda V L D S S

2020년 5월 28일

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

교육 기관: Chinmay P

2020년 7월 29일

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

교육 기관: Sahil K

2020년 8월 14일

Very helpful in knowledge building and good quality content.

교육 기관: SNEHA V

2020년 8월 8일

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

교육 기관: Ansumita B

2020년 5월 5일

I liked the course it was awesome learning from this coursea

교육 기관: David L

2019년 10월 29일

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

교육 기관: Maria T

2022년 3월 29일

V​ery informative on clinical trials and industrial issues.

교육 기관: Reem M A R

2020년 6월 28일

Great knowledge for steps of new drugs registration in FDA

교육 기관: Yashwantsinh J

2020년 6월 18일

Good learning prospectives and very interesting sessions.

교육 기관: Prateek K

2021년 10월 1일

i​mmersive and insightful across the pharma value chain.

교육 기관: CHANCHALA A

2020년 6월 27일

very useful to our knowledge happy to choose this course

교육 기관: KONKEPUDI G M

2020년 6월 15일

VERY HELPFUL FOR THE STUDENTS IN PHARMACEUTICAL SCIENCES

교육 기관: H C

2017년 8월 6일

I could understand about the process of drug development

교육 기관: Mohammed M H C

2020년 4월 18일

Excellent course and enriched materials with clear view

교육 기관: t. O

2019년 3월 14일

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

교육 기관: Arshad s

2019년 3월 10일

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

교육 기관: Ahmed

2020년 9월 21일

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

교육 기관: DEVIS M M D P

2020년 9월 17일

It teaches the kind of hidden part of drug development

교육 기관: Nancy Z

2021년 2월 1일

Perfect balance of scientific and business knowledge.

교육 기관: NALLIPOGU S T

2020년 9월 29일

Is this a good platform to gain knowledge in COURSERA

교육 기관: Talissa C M D B

2020년 7월 28일

Muito bom, apenas não consegui acessar o certificado

교육 기관: anubhav t

2021년 9월 12일

loved it... increased my understsanding of industry