Description
Book SynopsisA 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. It also includes associated regulatory requirements for the development of these therapies.
Table of ContentsPreface 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
