Chung Chow Chan 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.Kwok Chow 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.Bill McKay 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.Michelle Fung is currently a Clinical Associate Professor in the Division of Endocrinology & Metabolism, Department of Medicine, at the University of British Columbia.

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• Preface viiContributors ixACKNOWLEDGMENT xiSection 1 Requirements and Issues encountered in Regulatory Submissions in the Pharmaceutical, Cell Therapy and Medical Device Industries 11 Challenges to Quality and Regulatory Requirement in the United States—Drugs, Medical Device, and Cell Therapy 3Section 2 Traditional Pharmaceutical Drug Therapy Development 352 Development of Tablets 373 Formulation of Poorly Soluble Drugs for Oral Administration 67Section 3 Overview, Current Trends and Strategies of Special Medical Device Development 1054 Overview of Drug Delivery Devices 1075 Local Delivery of Bone Growth Factors 1356 Delivery of Insulin: From Glass Syringes to Feedback-Controlled Patch Pumps 163Section 4 Advances and Innovations in Cellular and Stem Cell Therapeutic Delivery 1797 Endocrine Therapeutic Delivery: Pancreatic Cell Transplant and Growth 1818 Cell-Based Biologic Therapy for the Treatment of Medical Diseases 2079 Development of Stem Cell Therapy for Medical Uses 239Section 5 Analytical Support Needed For the Research and Development 26910 Specification Setting and Stability Studies in the Development 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

Chung Chow Chan 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.Kwok Chow 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.Bill McKay 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.Michelle Fung is currently a Clinical Associate Professor in the Division of Endocrinology & Metabolism, Department of Medicine, at the University of British Columbia.

Select Guide Rating

• Preface viiContributors ixACKNOWLEDGMENT xiSection 1 Requirements and Issues encountered in Regulatory Submissions in the Pharmaceutical, Cell Therapy and Medical Device Industries 11 Challenges to Quality and Regulatory Requirement in the United States—Drugs, Medical Device, and Cell Therapy 3Section 2 Traditional Pharmaceutical Drug Therapy Development 352 Development of Tablets 373 Formulation of Poorly Soluble Drugs for Oral Administration 67Section 3 Overview, Current Trends and Strategies of Special Medical Device Development 1054 Overview of Drug Delivery Devices 1075 Local Delivery of Bone Growth Factors 1356 Delivery of Insulin: From Glass Syringes to Feedback-Controlled Patch Pumps 163Section 4 Advances and Innovations in Cellular and Stem Cell Therapeutic Delivery 1797 Endocrine Therapeutic Delivery: Pancreatic Cell Transplant and Growth 1818 Cell-Based Biologic Therapy for the Treatment of Medical Diseases 2079 Development of Stem Cell Therapy for Medical Uses 239Section 5 Analytical Support Needed For the Research and Development 26910 Specification Setting and Stability Studies in the Development 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