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Therapeutic Delivery Solutions

  • ID: 2766292
  • Book
  • 424 Pages
  • John Wiley and Sons Ltd
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Therapeutic Delivery Solutions presents a comprehensive review of the full range of potential medical therapeutic development solutions. The book discusses three therapeutic delivery platforms (Conventional Therapeutic Delivery System, Medical Device Therapeutic Delivery System, and Cellular Therapeutic Delivery) and their associated regulatory requirements. There is currently no other resource examining these three areas in one textbook. It allows development scientists, engineers and medical professionals more options to develop a therapeutic agent to its fullest potential and creates better and more creative therapeutic solutions.

The book is divided into 5 sections. Section 1 describes the regulatory requirements and issues encountered in pharmaceutical and medical device submissions. Section 2 gives a detail treatment of traditional and latest innovations in oral drug product development. Section 3 outlines current trends and strategies of combination medical devices therapy development including bone graft delivery systems, pulmonary delivery systems, and powder inhalation technology. Section 4 introduces the reader to the latest advances and innovations in cellular and stem cell therapeutic delivery such as cancer cell therapeutic delivery and stem cell therapeutic delivery. Section 5 provides information on how the developments in sections 1–4 are supported.
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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

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Chung Chow Chan
Kwok Chow
Bill McKay
Michelle Fung
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