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What are generic drugs? Learn about the life cycle from brand-name prescriptions to generic drugs. Discover how biopharmaceutical companies ...
YouTube-PhRMA
2012/08/15Blue's not feeling well. The prescription? Generic medication. This new PSA aims to increase overall understanding of generics as a safe and ...
YouTube-U.S. Food and Drug Administration
2017/09/14The Generic Drugs Forum is an annual, two-day event that offers attendees the opportunity to hear from FDA subject matter experts from every ...
YouTube-U.S. Food and Drug Administration
1か月前A MedStar pharmacist explains the benefits of using generic prescription drugs, when possible. Learn more: http://ow.ly/Midsz.
YouTube-MedStar Health
2010/02/17Dhaval K. Gaglani, CDER Office of Pharmaceutical Quality, discusses guidance updates, pre-market changes and considerations, and submission ...
YouTube-U.S. Food and Drug Administration
2020/07/24動画の見どころ1/10枚目 Intro
動画の見どころ2/10枚目 Generic Drug Cost Savings
動画の見どころ3/10枚目 Update on Guidance
動画の見どころ4/10枚目 Pre-market Submission Challenges
動画の見どころ5/10枚目 Challenges Associated with Device Information
動画の見どころ6/10枚目 Suitability of the container closure system
動画の見どころ7/10枚目 P7 Control Strategy
動画の見どころ8/10枚目 Particle Size Distribution
動画の見どころ9/10枚目 Premarket changes
動画の見どころ10/10枚目 Closing Remarks
... generic drug development, regulatory assessment, and approval. Part two of day one covers the second half of session one: Noteworthy ...
YouTube-U.S. Food and Drug Administration
2023/10/06... generic-drugs-forum-april-15-16-2020-04152020-04162020. FDA CDER's Small Business and Industry Assistance ...
YouTube-U.S. Food and Drug Administration
2020/05/01動画の見どころ1/10枚目 Purpose of assessment process
動画の見どころ2/10枚目 What are the different types of drug-device combination products?
動画の見どころ3/10枚目 Quality Assessment
動画の見どころ4/10枚目 Challenge Question
動画の見どころ5/10枚目 Core Regulation for Combination Products
動画の見どころ6/10枚目 Postmarket Safety Reporting for Combination Products
動画の見どころ7/10枚目 Summary and Resources
動画の見どころ8/10枚目 Regulatory History
動画の見どころ9/10枚目 Who needs to be in compliance with CFR Part 4, the application holder or the manufacturer of the drug product?
動画の見どころ10/10枚目 Prefilled syringe
Dr. Janet Woodcock, MD, acting Commissioner of Food and Drugs, delivers her Keynote Address to the 2021 Advancing Generic Drug Development: ...
YouTube-U.S. Food and Drug Administration
2021/10/07The Generic Drugs Forum is an annual, two-day event that offers attendees the opportunity to hear from FDA subject matter experts from every ...
YouTube-U.S. Food and Drug Administration
1か月前In this webinar, FDA discussed and provided updates on FDA and EMA's Parallel Scientific Advice (PSA) Pilot Program for complex ...
YouTube-U.S. Food and Drug Administration
2024/03/18Unlocking Global Access to Generic drugs
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products
International Engagement with OGD Parallel Scientific Advice (PSA) Process
EMA and International Engagement for Generics Development
Use of Foreign Comparators in Bioequivalence Studies for Health Canada
Discussion Panel
Presenter Q&A Discussion Panel
Closing Remarks
Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Generic Drugs covers considerations related to the ...
YouTube-U.S. Food and Drug Administration
2020/03/30動画の見どころ1/10枚目 Strategies for Generic Topical Product Development
動画の見どころ2/10枚目 Develop a thorough understanding of the reference product
動画の見どころ3/10枚目 Characterizing the Reference Product
動画の見どころ4/10枚目 Take-home messages
動画の見どころ5/10枚目 Amount of Mineral Oil
動画の見どころ6/10枚目 Corrected formulation
動画の見どころ7/10枚目 In vitro Characterization
動画の見どころ8/10枚目 Comparative Clinical Endpoint Study
動画の見どころ9/10枚目 Physical/Structural Characterization
動画の見どころ10/10枚目 Closing Remarks
A sharable infoGIF (this video has no sound) states that generic and brand-name medicines work the same.
YouTube-U.S. Food and Drug Administration
2017/12/21Markham C. Luke from CDER's Office of Generic Drugs discusses product-specific guidances for complex generic drugs.
YouTube-U.S. Food and Drug Administration
2021/05/14動画の見どころ1/10枚目 What are complex generic products?
動画の見どころ2/10枚目 Benefits of Product-Specific Guidances
動画の見どころ3/10枚目 Product-Specific Guidance Revisions
動画の見どころ4/10枚目 Examples of complex products
動画の見どころ5/10枚目 Topical complex products
動画の見どころ6/10枚目 Complex API and Formulation Products
動画の見どころ7/10枚目 Complex Drug-Device Products
動画の見どころ8/10枚目 Examples of product-specific guidances for complex drug products
動画の見どころ9/10枚目 Pharmacokinetic Study
動画の見どころ10/10枚目 Conclusion
FDA's Director of the Office of Generic Drugs Kathleen Uhl, MD, provides the opening keynote. FDA CDER's Small Business and Industry ...
YouTube-U.S. Food and Drug Administration
2020/05/22John Gribben, MD, DSc, FRCPath, FMed Sci from Barts Cancer Institute, London, UK compares the use of generic drugs to biosimilars at the ...
YouTube-VJHemOnc – Video Journal of Hematology & HemOnc
2017/06/20FDA discusses topics in complex generic nasal and inhalation products. Includes responses to audience in a question-and-answer panel.
YouTube-U.S. Food and Drug Administration
2021/10/07The purpose of this webinar was to provide current and prospective generic drug applicants insight on how PSGs are developed, revised, ...
YouTube-U.S. Food and Drug Administration
1週間前PSG Program: Updates and Overview of Available Resources
Beyond General Guidance: Tailored PSG Recommendations for Immediate Release Oral Drug Products
Development of Generic Drug Products Under Suitability Petition
Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs
Consideration Factors for Study Population Selection in Bioequivalence Studies with Pharmacokinetic Endpoints
FDA Dissolution Methods and Navigating the Dissolution Database
Panel Discussion
Speaker Q&A Discussion Panel
Closing Remarks
Dave Coppersmith and Myong-Jin Kim from CDER's Office of Generic Drugs provide information on product-specific guidances (PSGs).
YouTube-U.S. Food and Drug Administration
2020/05/01動画の見どころ1/10枚目 Learning Objectives
動画の見どころ2/10枚目 PSG Recommendations
動画の見どころ3/10枚目 Locating PSGs (cont.)
動画の見どころ4/10枚目 Comments on Draft PSGS
動画の見どころ5/10枚目 A Recent Major Effort in PSG Revision: Fed/Fasting BE Studies
動画の見どころ6/10枚目 Additional sources of Help Besides PSGS
動画の見どころ7/10枚目 Planned Revision Categories
動画の見どころ8/10枚目 Challenge Question 1
動画の見どころ9/10枚目 Summary
動画の見どころ10/10枚目 Resources
Linda Forsyth, Edward Kim, and Debbie Catterson from CDER's Office of Generic Drugs Clinical Safety Surveillance Staff describe clinical ...
YouTube-U.S. Food and Drug Administration
2020/05/01動画の見どころ1/10枚目 Physician Reviewer's Role in the Premarket Safety Review of Generic Drugs
動画の見どころ2/10枚目 What about studies conducted abroad?
動画の見どころ3/10枚目 Product-Specific Guidance
動画の見どころ4/10枚目 Generic Drug Post-Market Pharmacovigilance
動画の見どころ5/10枚目 Challenges to adverse event reporting
動画の見どころ6/10枚目 Conclusion
動画の見どころ7/10枚目 Real-Life Examples of Safety Issues
動画の見どころ8/10枚目 Auto-injectors
動画の見どころ9/10枚目 Which website or link is the correct website to perform literature research?
動画の見どころ10/10枚目 Closing Remarks
Generic drugs can be introduced after the patent for the brand-name runs out. So, what's the difference between brand-name and generic drugs ...
YouTube-WCCO - CBS Minnesota
2016/08/29