Therapeutic delivery solutions:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Hoboken, N.J.
Wiley
2014
|
| Schlagworte: | |
| Online-Zugang: | Klappentext Inhaltsverzeichnis |
| Beschreibung: | XI, 410 S. Ill., graph. Darst. |
| ISBN: | 9781118111260 |
Internformat
MARC
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Datensatz im Suchindex
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| adam_text | 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. The information
presented aims to assist development of a therapeutic agent to its fullest potential, and to inspire
scientists, engineers, and medical professionals to create better and more innovative 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 detailed
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.
• Covers traditional pharmaceutical product development, innovative medical device therapy
treatment, and the latest advances in cellular and stem cell therapy development
• Covers analytical and related support for therapeutic solutions, including setting product
specification, stability and dissolutions studies, and liquid chromatography-mass spectrometry
(LC-MS) application
• Includes associated regulatory requirements for the development of these therapies
• Provides a comprehensive treatment of therapeutic delivery solution development
CONTENTS
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
v
vi
CONTENTS
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 ICH Quality Guidelines: Their Global Impact 367
14 Out of Speeification/Atypical Result Investigation 381
INDEX
405
|
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| illustrated | Illustrated |
| indexdate | 2024-07-10T07:08:13Z |
| institution | BVB |
| isbn | 9781118111260 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-028154233 |
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| physical | XI, 410 S. Ill., graph. Darst. |
| publishDate | 2014 |
| publishDateSearch | 2014 |
| publishDateSort | 2014 |
| publisher | Wiley |
| record_format | marc |
| spelling | Therapeutic delivery solutions ed. by Chung Chow Chan ... Hoboken, N.J. Wiley 2014 XI, 410 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Arzneistoffträger (DE-588)4278196-6 gnd rswk-swf Lösung Chemie (DE-588)4036159-7 gnd rswk-swf Arzneistoffträger (DE-588)4278196-6 s Lösung Chemie (DE-588)4036159-7 s DE-604 Chan, Chung Chow Sonstige oth Digitalisierung UB Regensburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028154233&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Klappentext Digitalisierung UB Regensburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028154233&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Therapeutic delivery solutions Arzneistoffträger (DE-588)4278196-6 gnd Lösung Chemie (DE-588)4036159-7 gnd |
| subject_GND | (DE-588)4278196-6 (DE-588)4036159-7 |
| title | Therapeutic delivery solutions |
| title_auth | Therapeutic delivery solutions |
| title_exact_search | Therapeutic delivery solutions |
| title_full | Therapeutic delivery solutions ed. by Chung Chow Chan ... |
| title_fullStr | Therapeutic delivery solutions ed. by Chung Chow Chan ... |
| title_full_unstemmed | Therapeutic delivery solutions ed. by Chung Chow Chan ... |
| title_short | Therapeutic delivery solutions |
| title_sort | therapeutic delivery solutions |
| topic | Arzneistoffträger (DE-588)4278196-6 gnd Lösung Chemie (DE-588)4036159-7 gnd |
| topic_facet | Arzneistoffträger Lösung Chemie |
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