All NewsTop NewsIndustry NewsBio/Pharma NewsSupplier NewsNews from EuropeEvents
All PublicationsPharmTechPharmTech Europe
Front & CenterPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
WebcastsMarketplace
Ask the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy Science
Conference CoverageConference Listing
BusinessSubscribe
AnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalytics
Best Practices
Bio/Pharma Business
Bio/Pharma and Brexit
COVID-19 Update
Conferences
Deals, Development and Manufacturing
DevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopment
Dosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
From the CEO
From the Editor
Front & Center
Global Perspectives
Inside Standards
Insider Solutions
Intellectual Property & Patents
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
Mergers and Acquisitions
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Peer-Reviewed Research
PharmTech Talk
Quality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality Systems
Statistical Solutions
Therapeutic-Specific Areas
Troubleshooting
Viewpoints
Weighing Up Big Pharma
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
AnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalyticsAnalytics
Best Practices
Bio/Pharma Business
Bio/Pharma and Brexit
COVID-19 Update
Conferences
Deals, Development and Manufacturing
DevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopmentDevelopment
Dosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
From the CEO
From the Editor
Front & Center
Global Perspectives
Inside Standards
Insider Solutions
Intellectual Property & Patents
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
Mergers and Acquisitions
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Peer-Reviewed Research
PharmTech Talk
Quality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality SystemsQuality Systems
Statistical Solutions
Therapeutic-Specific Areas
Troubleshooting
Viewpoints
Weighing Up Big Pharma
    • Webcasts
    • Marketplace
    • Business
    • Subscribe
Advertisement

Helen Winkle

home / authors / helen-winkle

Helen Winkle is director of the Office of Pharmaceutical Science.

Articles

Quality by Design for Generic Drugs

Quality by Design for Generic Drugs

Robert Lionberger;Gordon Johnston;Lawrence X. Yu;Gary Buehler;Michael C. Olson;Helen Winkle
October 2nd 2009

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Europa Perspectives: Helping to Navigate the Regulatory System
Published: February 23rd 2024 | Updated: December 21st 2024
Europa Perspectives: Helping to Navigate the Regulatory System
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: December 13th 2024 | Updated: December 21st 2024
FDA Creates CDER Center for Real-World Evidence Innovation
Close-up of a microscope lens examining microarray slides, a crucial tool in genomic research and medical diagnostics | Image Credit: © Varunee - Stock.Adobe.com
Published: December 5th 2024 | Updated: December 21st 2024
Leveraging Advancements in Bioanalytical Testing
Lipid nanoparticle siRNA antiviral delivery system, 3D illustration | Image Credit: © Dr_Microbe - © Dr_Microbe - stock.adobe.com
Published: December 7th 2024 | Updated: December 21st 2024
Exploring Opportunities for LNP Delivery in mRNA
About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2024 MJH Life Sciences

All rights reserved.