More Books:

Development and Approval of Combination Products
Language: en
Pages: 216
Authors: Evan B. Siegel
Categories: Medical
Type: BOOK - Published: 2008-06-09 - Publisher: John Wiley & Sons

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful
Combination Products
Language: en
Pages: 264
Authors: Smita Gopalaswamy, Venky Gopalaswamy
Categories: Medical
Type: BOOK - Published: 2008-04-22 - Publisher: CRC Press

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the
Clinical Evaluation of Medical Devices
Language: en
Pages: 360
Authors: Karen M. Becker, John J. Whyte
Categories: Technology & Engineering
Type: BOOK - Published: 2007-11-05 - Publisher: Springer Science & Business Media

The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and
Drug-Device Combination Products
Language: en
Pages: 560
Authors: Andrew Lewis
Categories: Medical
Type: BOOK - Published: 2009-12-15 - Publisher: Elsevier

Drug delivery systems represent a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug delivery devices continues to drive novel product development. Advanced drug delivery devices can offer significant advantages over conventional drugs and devices alone, such as increased efficiency, improved performance and
Pharmaceutical Stability Testing to Support Global Markets
Language: en
Pages: 266
Authors: Kim Huynh-Ba
Categories: Medical
Type: BOOK - Published: 2009-12-04 - Publisher: Springer Science & Business Media

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the