Kwok Chow & Bill McKay 
Therapeutic Delivery Solutions [PDF ebook] 

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

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 Mc Kay 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.