Data Requirements for Biosimilars

  Рет қаралды 26,864

U.S. Food and Drug Administration

U.S. Food and Drug Administration

6 жыл бұрын

FDA-approved biosimilars require data from multiple studies and analytical tools to demonstrate analytical similarity to reference products. Learn more with Dr. Steve Kozlowski, M.D., Director at FDA’s Center for Drug Evaluation and Research. For more information, visit www.FDA.gov/bi...

Пікірлер
The Biosimilar Development Process
4:20
The Biosimilar Development Process
U.S. Food and Drug Administration
Рет қаралды 36 М.
Biosimilars: Manufacturing and Inherent Variation
3:33
Biosimilars: Manufacturing and Inherent Variation
U.S. Food and Drug Administration
Рет қаралды 13 М.
孩子太多！一碗水真的能端平吗？ #瞧这一家子 #带娃 #四小只吖 #日常 #搞笑 #搞笑家庭 #姐弟 #家庭生活
00:19
孩子太多！一碗水真的能端平吗？ #瞧这一家子 #带娃 #四小只吖 #日常 #搞笑 #搞笑家庭 #姐弟 #家庭生活
四小只吖
Рет қаралды 10 МЛН
Dad gives best memory keeper
01:00
Dad gives best memory keeper
Justin Flom
Рет қаралды 20 МЛН
Incredible Dog Rescues Kittens from Bus - Inspiring Story #shorts
00:18
Incredible Dog Rescues Kittens from Bus - Inspiring Story #shorts
Fabiosa Best Lifehacks
Рет қаралды 34 МЛН
Touching Act of Kindness Brings Hope to the Homeless #shorts
00:18
Touching Act of Kindness Brings Hope to the Homeless #shorts
Fabiosa Best Lifehacks
Рет қаралды 18 МЛН
The Basics of Biosimilars
4:12
The Basics of Biosimilars
U.S. Food and Drug Administration
Рет қаралды 68 М.
Idea to IDE: A Medical Device in the Making
10:29
Idea to IDE: A Medical Device in the Making
U.S. Food and Drug Administration
Рет қаралды 56 М.
Biosimilars: Critical Quality Attributes
3:12
Biosimilars: Critical Quality Attributes
U.S. Food and Drug Administration
Рет қаралды 8 М.
The Concept of Interchangeability
4:20
The Concept of Interchangeability
U.S. Food and Drug Administration
Рет қаралды 22 М.
Biosimilars: Approval Process
2:47
Biosimilars: Approval Process
U.S. Food and Drug Administration
Рет қаралды 9 М.
Biomarker Terminology: Speaking the Same Language
5:33
Biomarker Terminology: Speaking the Same Language
U.S. Food and Drug Administration
Рет қаралды 19 М.
Increasing the Efficiency of Biosimilar Development Programs (Day 2)
2:51:28
Increasing the Efficiency of Biosimilar Development Programs (Day 2)
U.S. Food and Drug Administration
Рет қаралды 2,4 М.
What Are Biomarkers And Why Are They Important?
2:05
What Are Biomarkers And Why Are They Important?
U.S. Food and Drug Administration
Рет қаралды 73 М.
5 Things You Need to Know About the Drug Approval Process
2:02
5 Things You Need to Know About the Drug Approval Process
U.S. Food and Drug Administration
Рет қаралды 84 М.
17. More than 12,000 highly qualified scientists work at the FDA. #FDAFacts
0:31
17. More than 12,000 highly qualified scientists work at the FDA. #FDAFacts
U.S. Food and Drug Administration
Рет қаралды 75
IPhone Microscope 🔬#2024#ipl #iphone#instagram #microscope#tiktok#youtube #ytshort#youtubeshorts
1:00
IPhone Microscope 🔬#2024#ipl #iphone#instagram #microscope#tiktok#youtube #ytshort#youtubeshorts
I love ♥️you life
Рет қаралды 10 МЛН
iPhone Vs Samsung Drop test #iphone #Samsung #samsungsmartphone samsung
1:01
iPhone Vs Samsung Drop test #iphone #Samsung #samsungsmartphone samsung
Android Wala
Рет қаралды 25 МЛН
Huawei провалилась! Apple тут ни при чем!
0:59
Huawei провалилась! Apple тут ни при чем!
ÉЖИ АКСЁНОВ
Рет қаралды 1,4 МЛН
You can play MC and protect your iPad at the same time, do you still need to choose? #ipadkeyboard
0:13
You can play MC and protect your iPad at the same time, do you still need to choose? #ipadkeyboard
Typecase
Рет қаралды 7 МЛН
😱ЖИВОЙ Чехол на Айфон🤪
0:38
😱ЖИВОЙ Чехол на Айфон🤪
Demin's Lounge
Рет қаралды 315 М.
Нашли телефон спустя 5 лет
0:25
Нашли телефон спустя 5 лет
Up Your Brains
Рет қаралды 4,1 МЛН
Xiaomi or Samsung #satisfying #colormixing #sharkzhan
0:19
Xiaomi or Samsung #satisfying #colormixing #sharkzhan
Shark Zhan
Рет қаралды 15 МЛН