Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future

ISSN: 1550-7416 (Online)

In this topical collection (13 articles)

  1. No Access

    Review Article

    Nanomaterial Drug Products: Manufacturing and Analytical Perspectives

    Christie M. Sayes, Grace V. Aquino, Anthony J. Hickey Pages 18-25

  2. No Access

    Review Article

    Physiologically Based Pharmacokinetic (PBPK) Modeling of Pharmaceutical Nanoparticles

    Min Li, Peng Zou, Katherine Tyner, Sau Lee Pages 26-42

  3. No Access

    Research Article

    Early Development Challenges for Drug Products Containing Nanomaterials

    Jennifer H. Grossman, Rachael M. Crist, Jeffrey D. Clogston Pages 92-102

  4. No Access

    Review Article

    Clinical Translation of the National Institutes of Health’s Investments in Nanodrug Products and Devices

    Lori A. Henderson, Lalitha K. Shankar Pages 343-359

  5. No Access

    Review Article

    Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials

    Nan Zheng, Dajun D. Sun, Peng Zou, Wenlei Jiang Pages 619-631

  6. No Access

    Review Article

    Liposomal Drug Product Development and Quality: Current US Experience and Perspective

    Mamta Kapoor, Sau L. Lee, Katherine M. Tyner Pages 632-641

  7. No Access

    Review Article

    Development Considerations for Nanocrystal Drug Products

    Mei-Ling Chen, Mathew John, Sau L. Lee, Katherine M. Tyner Pages 642-651

  8. No Access

    Regulatory Note

    How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities

    Katherine M. Tyner, Nan Zheng, Stephanie Choi, Xiaoming Xu, Peng Zou… Pages 1071-1083

  9. No Access

    Commentary

    Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials

    Henry A. Havel Pages 1351-1353

  10. No Access

    Commentary

    A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products

    Greg Troiano, Jim Nolan, Donald Parsons, Christina Van Geen Hoven… Pages 1354-1365

  11. No Access

    Review Article

    Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products

    Peng Zou, Katherine Tyner, Andre Raw, Sau Lee Pages 1359-1376

  12. No Access

    Review Article

    Nanomedicines: From Bench to Bedside and Beyond

    Henry Havel, Gregory Finch, Pamela Strode, Marc Wolfgang, Stephen Zale… Pages 1373-1378

  13. No Access

    Regulatory Note

    Nanomedicines in the EU—Regulatory Overview

    Ruben Pita, Falk Ehmann, Marisa Papaluca Pages 1576-1582