Provides a comprehensive review of all types of medical therapeuticdelivery solutions from traditional pharmaceutical therapydevelopment to innovative medical device therapy treatment to therecent advances in cellular and stem cell therapy development* Provides information to potentially allow futuredevelopment of treatments with greater therapeutic potential andcreativity* Includes associated regulatory requirements for thedevelopment of these therapies* Provides a comprehensive developmental overview ontherapeutic delivery solutions* Provides overview information for both thegeneral reader as well as more detailed references forprofessionals and specialists in the field

Preface viiContributors ixACKNOWLEDGMENT xiSection 1 Requirements and Issues encountered in RegulatorySubmissions in the Pharmaceutical, Cell Therapy and Medical DeviceIndustries 11 Challenges to Quality and Regulatory Requirement in the UnitedStates--Drugs, Medical Device, and Cell Therapy 3Section 2 Traditional Pharmaceutical Drug Therapy Development352 Development of Tablets 373 Formulation of Poorly Soluble Drugs for Oral Administration67Section 3 Overview, Current Trends and Strategies of SpecialMedical Device Development 1054 Overview of Drug Delivery Devices 1075 Local Delivery of Bone Growth Factors 1356 Delivery of Insulin: From Glass Syringes toFeedback-Controlled Patch Pumps 163Section 4 Advances and Innovations in Cellular and Stem CellTherapeutic Delivery 1797 Endocrine Therapeutic Delivery: Pancreatic Cell Transplant andGrowth 1818 Cell-Based Biologic Therapy for the Treatment of MedicalDiseases 2079 Development of Stem Cell Therapy for Medical Uses 239Section 5 Analytical Support Needed For the Research andDevelopment 26910 Specification Setting and Stability Studies in theDevelopment of Therapeutic Delivery Solution 27111 LC-MS for Pharmaceutical Analysis 31512 Biorelevant Dissolution Testing 33513 I CH Quality Guidelines: Their Global Impact 36714 Out of Specification/Atypical Result Investigation 381Index 405