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Therapeutic Delivery Solutions

Therapeutic Delivery Solutions

Chung Chow Chan, Kwok Chow, Bill McKay, Michelle Fung

ISBN: 978-1-118-11126-0

Jul 2014

424 pages

In Stock



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


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