Therapeutic Delivery Solutions

Provides a comprehensive review of all types of medical therapeutic delivery solutions from traditional pharmaceutical therapy development to innovative medical device therapy treatment to the recent advances in cellular and stem cell therapy development • Provides information to potentially allow future development of treatments with greater therapeutic potential and creativity • Includes associated regulatory requirements for the development of these therapies • Provides a comprehensive developmental overview on therapeutic delivery solutions • Provides overview information for both the  general reader as well as more detailed references for professionals and specialists in the field

Preface vii Contributors ix ACKNOWLEDGMENT xi Section 1 Requirements and Issues encountered in Regulatory Submissions in the Pharmaceutical, Cell Therapy and Medical Device Industries 1 1 Challenges to Quality and Regulatory Requirement in the United States—Drugs, Medical Device, and Cell Therapy 3 Section 2 Traditional Pharmaceutical Drug Therapy Development 35 2 Development of Tablets 37 3 Formulation of Poorly Soluble Drugs for Oral Administration 67 Section 3 Overview, Current Trends and Strategies of Special Medical Device Development 105 4 Overview of Drug Delivery Devices 107 5 Local Delivery of Bone Growth Factors 135 6 Delivery of Insulin: From Glass Syringes to Feedback-Controlled Patch Pumps 163 Section 4 Advances and Innovations in Cellular and Stem Cell Therapeutic Delivery 179 7 Endocrine Therapeutic Delivery: Pancreatic Cell Transplant and Growth 181 8 Cell-Based Biologic Therapy for the Treatment of Medical Diseases 207 9 Development of Stem Cell Therapy for Medical Uses 239 Section 5 Analytical Support Needed For the Research and Development 269 10 Specification Setting and Stability Studies in the Development of Therapeutic Delivery Solution 271 11 LC-MS for Pharmaceutical Analysis 315 12 Biorelevant Dissolution Testing 335 13 I CH Quality Guidelines: Their Global Impact 367 14 Out of Specification/Atypical Result Investigation 381 Index 405