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.

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

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.