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

<p><b>Chung Chow Chan</b> is currently with CCC Consulting/Covar Inc and provides services for analytical method development and validation, pre-formulation, formulation development, and CMC strategy building. He was Senior Director with Azopharma and had managed the drug developments programs for Phase 1 Express projects and analytical development laboratory.</p> <p><b>Kwok Chow</b> was the Senior Director of Global PDS Technology and Alliances at Patheon Inc. with the responsibility of developing/introducing new technologies, establishing strategic technical alliances and providing scientific input in the pharmaceutical development of challenging molecules.  Currently he is the Director of Covar Inc. responsible for pharmaceutical consulting and formulation development services.</p> <p><b>Bill McKay</b> has over 30 years of product development experience in the Orthopaedic device business developing orthopaedic implants and combination drug/device products. He is currently Vice President of Biologics Research and Development at Medtronic Spinal and Biologics where he has developed and launched several unique bone grafting technologies and is developing novel locally delivered pain therapies.  He has more than 100 patents and applications.</p> <p><b>Michelle Fung</b> is currently a Clinical Associate Professor in the Division of Endocrinology & Metabolism, Department of Medicine, at the University of British Columbia.</p>

<p>Therapeutic Delivery Solutions presents a comprehensive review of the full range of potential medical therapeutic development solutions. The book discusses three therapeutic delivery platforms (Conventional Therapeutic Delivery System, Medical Device Therapeutic Delivery System, and Cellular Therapeutic Delivery) and their associated regulatory requirements. There is currently no other resource examining these three areas in one textbook. It allows development scientists, engineers and medical professionals more options to develop a therapeutic agent to its fullest potential and creates better and more creative therapeutic solutions.</p> The book is divided into 5 sections. Section 1 describes the regulatory requirements and issues encountered in pharmaceutical and medical device submissions. Section 2 gives a detail treatment of traditional and latest innovations in oral drug product development. Section 3 outlines current trends and strategies of combination medical devices therapy development including bone graft delivery systems, pulmonary delivery systems, and powder inhalation technology. Section 4 introduces the reader to the latest advances and innovations in cellular and stem cell therapeutic delivery such as cancer cell therapeutic delivery and stem cell therapeutic delivery. Section 5 provides information on how the developments in sections 1-4 are supported.

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