Chan / Chow / McKay Therapeutic Delivery Solutions

1. Auflage 2014
ISBN: 978-1-118-90349-0
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 424 Seiten, E-Book

Provides a comprehensive review of all types of medical therapeuticdelivery solutions from traditional pharmaceutical therapydevelopment to innovative medical device therapy treatment to therecent advances in cellular and stem cell therapy development
* Provides information to potentially allow futuredevelopment of treatments with greater therapeutic potential andcreativity
* Includes associated regulatory requirements for thedevelopment of these therapies
* Provides a comprehensive developmental overview ontherapeutic delivery solutions
* Provides overview information for both the general reader as well as more detailed references forprofessionals and specialists in the field

Autoren/Hrsg.

Chan, Chung Chow

Chow, Kwok

McKay, Bill

Fung, Michelle

Inhaltsverzeichnis

Preface vii
Contributors ix
ACKNOWLEDGMENT xi
Section 1 Requirements and Issues encountered in RegulatorySubmissions in the Pharmaceutical, Cell Therapy and Medical DeviceIndustries 1
1 Challenges to Quality and Regulatory Requirement in the UnitedStates--Drugs, Medical Device, and Cell Therapy 3
Section 2 Traditional Pharmaceutical Drug Therapy Development35
2 Development of Tablets 37
3 Formulation of Poorly Soluble Drugs for Oral Administration67
Section 3 Overview, Current Trends and Strategies of SpecialMedical 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 toFeedback-Controlled Patch Pumps 163
Section 4 Advances and Innovations in Cellular and Stem CellTherapeutic Delivery 179
7 Endocrine Therapeutic Delivery: Pancreatic Cell Transplant andGrowth 181
8 Cell-Based Biologic Therapy for the Treatment of MedicalDiseases 207
9 Development of Stem Cell Therapy for Medical Uses 239
Section 5 Analytical Support Needed For the Research andDevelopment 269
10 Specification Setting and Stability Studies in theDevelopment 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

Über Autor(innen)

Chung Chow Chan is currently with CCC Consulting/CovarInc and provides services for analytical method development andvalidation, pre-formulation, formulation development, and CMCstrategy building. He was Senior Director with Azopharma and hadmanaged the drug developments programs for Phase 1 Express projectsand analytical development laboratory.
Kwok Chow was the Senior Director of Global PDSTechnology and Alliances at Patheon Inc. with the responsibility ofdeveloping/introducing new technologies, establishing strategictechnical alliances and providing scientific input in thepharmaceutical development of challenging molecules. Currently he is the Director of Covar Inc. responsible forpharmaceutical consulting and formulation development services.
Bill McKay has over 30 years of product developmentexperience in the Orthopaedic device business developingorthopaedic implants and combination drug/device products. He iscurrently Vice President of Biologics Research and Development atMedtronic Spinal and Biologics where he has developed and launchedseveral unique bone grafting technologies and is developing novellocally delivered pain therapies. He has more than 100patents and applications.
Michelle Fung is currently a Clinical Associate Professorin the Division of Endocrinology & Metabolism, Department ofMedicine, at the University of British Columbia.