Chung Chow (Eli Lilly Canada, Inc., Canada ) Chan,
CC Chan,
Kwok Chow,
Bill McKay,
Michelle Fung
e.a.
John Wiley & Sons
e druk, 2014
9781118111260
Therapeutic Delivery Solutions
Specificaties
Gebonden, 424 blz.
|
Engels
John Wiley & Sons |
e druk, 2014
ISBN13: 9781118111260
Rubricering
Verwachte levertijd ongeveer 9 werkdagen
Samenvatting
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
Specificaties
Inhoudsopgave
<p>Preface vii</p>
<p>Contributors ix</p>
<p>ACKNOWLEDGMENT xi</p>
<p>Section 1 Requirements and Issues encountered in Regulatory Submissions in the Pharmaceutical, Cell Therapy and Medical Device Industries 1</p>
<p>1 Challenges to Quality and Regulatory Requirement in the United States Drugs, Medical Device, and Cell Therapy 3</p>
<p>Section 2 Traditional Pharmaceutical Drug Therapy Development 35</p>
<p>2 Development of Tablets 37</p>
<p>3 Formulation of Poorly Soluble Drugs for Oral Administration 67</p>
<p>Section 3 Overview, Current Trends and Strategies of Special Medical Device Development 105</p>
<p>4 Overview of Drug Delivery Devices 107</p>
<p>5 Local Delivery of Bone Growth Factors 135</p>
<p>6 Delivery of Insulin: From Glass Syringes to Feedback–Controlled Patch Pumps 163</p>
<p>Section 4 Advances and Innovations in Cellular and Stem Cell Therapeutic Delivery 179</p>
<p>7 Endocrine Therapeutic Delivery: Pancreatic Cell Transplant and Growth 181</p>
<p>8 Cell–Based Biologic Therapy for the Treatment of Medical Diseases 207</p>
<p>9 Development of Stem Cell Therapy for Medical Uses 239</p>
<p>Section 5 Analytical Support Needed For the Research and Development 269</p>
<p>10 Specification Setting and Stability Studies in the Development of Therapeutic Delivery Solution 271</p>
<p>11 LC–MS for Pharmaceutical Analysis 315</p>
<p>12 Biorelevant Dissolution Testing 335</p>
<p>13 I CH Quality Guidelines: Their Global Impact 367</p>
<p>14 Out of Specification/Atypical Result Investigation 381</p>
<p>Index 405</p>
<p>Contributors ix</p>
<p>ACKNOWLEDGMENT xi</p>
<p>Section 1 Requirements and Issues encountered in Regulatory Submissions in the Pharmaceutical, Cell Therapy and Medical Device Industries 1</p>
<p>1 Challenges to Quality and Regulatory Requirement in the United States Drugs, Medical Device, and Cell Therapy 3</p>
<p>Section 2 Traditional Pharmaceutical Drug Therapy Development 35</p>
<p>2 Development of Tablets 37</p>
<p>3 Formulation of Poorly Soluble Drugs for Oral Administration 67</p>
<p>Section 3 Overview, Current Trends and Strategies of Special Medical Device Development 105</p>
<p>4 Overview of Drug Delivery Devices 107</p>
<p>5 Local Delivery of Bone Growth Factors 135</p>
<p>6 Delivery of Insulin: From Glass Syringes to Feedback–Controlled Patch Pumps 163</p>
<p>Section 4 Advances and Innovations in Cellular and Stem Cell Therapeutic Delivery 179</p>
<p>7 Endocrine Therapeutic Delivery: Pancreatic Cell Transplant and Growth 181</p>
<p>8 Cell–Based Biologic Therapy for the Treatment of Medical Diseases 207</p>
<p>9 Development of Stem Cell Therapy for Medical Uses 239</p>
<p>Section 5 Analytical Support Needed For the Research and Development 269</p>
<p>10 Specification Setting and Stability Studies in the Development of Therapeutic Delivery Solution 271</p>
<p>11 LC–MS for Pharmaceutical Analysis 315</p>
<p>12 Biorelevant Dissolution Testing 335</p>
<p>13 I CH Quality Guidelines: Their Global Impact 367</p>
<p>14 Out of Specification/Atypical Result Investigation 381</p>
<p>Index 405</p>
