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

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