9780824754624

Drug Products for Clinical Trials, Second Edition

by ;
  • ISBN13:

    9780824754624

  • ISBN10:

    082475462X

  • Edition: 2nd
  • Format: Hardcover
  • Copyright: 2005-11-09
  • Publisher: CRC Press

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Summary

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

Table of Contents

Preface iii
Contributors xv
1. The Clinical Trials Material Professional: A Changing Role
1(20)
Donald C. Monkhouse
Introduction
1(5)
Administrative/Organizational Role
6(4)
Outside Influences
10(9)
Conclusions
19(1)
References
19(2)
2. Discovery and Formulation Trends for the Clinical Trials Material Professional
21(48)
Donald C. Monkhouse
Discovery Trends
21(9)
Physicochemical Characterization
30(4)
Dissolution and Absorption
34(5)
Alternate Routes of Administration
39(5)
Biologicals
44(3)
Drug Delivery/Products
47(17)
Conclusions
64(1)
References
64(5)
3. Manufacturing and Clinical Medicine Trends for the Clinical Trials Material Professional
69(42)
Donald C. Monkhouse
Introduction
69(1)
Manufacturing Processes
70(8)
Manufacturing Trends
78(11)
Information Technology
89(6)
Clinical
95(7)
Development Considerations
102(3)
Conclusions: Considerations for the Clinical Trials Material Professional
105(4)
References
109(2)
4. Quality Assurance Systems for Global Companies
111(18)
Mabel Fernández and Ute Lehmann
Introduction
111(1)
Research and Development Quality System
112(10)
Global Quality Assurance for Clinical Supplies Preparation
122(5)
Summary and Conclusions
127(1)
References
127(2)
5. Special Facilities for Developing, Manufacturing, and Packaging Potent or Hazardous Drug Products
129(20)
Doug Grevatt and Christopher E. Lockwood
Introduction
129(1)
Handling of Potent Compounds
130(14)
In-House vs. Outsourcing
144(3)
Conclusions
147(1)
References
147(2)
6. Blinding of Drug Products
149(24)
Peter Brun
What Is "Blinding"?
149(1)
When Is Blinding Required?
150(1)
Comparator Medication
151(6)
Methods of Blinding for Solid Oral Dosage Forms
157(12)
Methods of Blinding for Oral Liquids
169(1)
Methods of Blinding for Injectable Solutions, Powder for Reconstitution, and Lyophilised Powder
170(1)
Methods of Blinding for Metered Dose Inhalers
170(1)
Methods of Blinding for Creams and Ointments
171(1)
Conclusion/Summary
171(2)
7. Developing and Practical Uses for Interactive Voice Response Systems and Other Electronic Record Keeping
173(24)
Charles Gettis and Jennifer Nydell
Interactive Voice Response System Definition, Purpose, Advantages, Technology, and Considerations for Global Use
173(7)
Developing and Implementing an In-House (Proprietary) IVRS
180(1)
How to Choose an IVRS Vendor?
181(3)
Integrating IVRS into the Clinical Research Protocol
184(1)
Specifications and System Requirements
184(4)
Automated Record-Keeping System
188(1)
The 21 CFR Part-11 Compliance
189(1)
IVRS as a Trial Management Tool
190(5)
Future
195(2)
8. Outsourcing Clinical Supply Materials
197(24)
Michael Hardy and Eugene J. McNally
Introduction
197(1)
Elements of a Successful Vendor Selection Process
198(7)
Contractor and Client Communication Strategies
205(8)
Appendix
213(8)
9. Training for Clinical Trial Material (CTM) Professionals
221(32)
Jeri Weigand
Introduction
221(3)
Background Information for Trainers
224(4)
CTM Training Requirements
228(3)
Training Documentation
231(1)
Training Ideas
231(2)
Training Assessment
233(1)
Conclusion
233(2)
References
235(1)
Appendices
236(17)
10. Inhalation Products in Clinical Trials 253(24)
Lynn Van Campen
Introduction
253(2)
The Drug Product
255(7)
Regulatory
262(2)
Preclinical Product Development
264(4)
Manufacturing and Packaging
268(3)
Quality Control
271(2)
Animal Toxicology Testing
273(1)
Clinical Product Development
273(2)
Summary
275(1)
References
275(2)
11. Overseas Trials 277(14)
Diane Mustafa, Frank Reale, and Steven Jacobs
Introduction
277(1)
World Regulatory Issues
278(1)
Overseas Trials Concerns for the Clinical Supplies Professional
278(5)
Manufacturing
283(1)
International Outsourcing
284(1)
Blinding Techniques
285(2)
Expiration/Retest Dating
287(1)
CR/SF Packaging
287(1)
BSE/TSE Concerns
288(3)
12. Overview of (Some) Attempts at Harmonization 291(20)
Alan G. Minsk and David L. Hoffman
Inspections
292(7)
Product Approval
299(9)
Conclusion
308(1)
References
308(3)
13. Clinical Supply Packaging 311(42)
Dorothy M. Dolfini and Frank J. Tiano
Introduction
311(2)
Communication, Scheduling, and Planning
313(3)
Choice of Package
316(8)
Packaging Components
324(6)
Packaging Equipment Considerations
330(14)
In-Process Testing
344(1)
Labeling
345(1)
Assemblage
346(3)
Documentation
349(1)
Training
350(1)
Summary
350(1)
References
350(3)
14. Project Management 353(38)
Jim Krupa
Introduction
353(2)
Overview of Drug Development
355(2)
The Steps in Drug Development
357(1)
Principles of Project Management
358(3)
The Key Role of Project Management
361(1)
Team Member Responsibilities
362(1)
Maintaining Vital Communications
363(3)
Logistics of Supplies
366(6)
Clinical Trial Material (CTM) Supplies
372(1)
Management of Drug Product
373(1)
Comparators
373(5)
Management of the IND
378(2)
Protocol Changes/Amendments
380(1)
Management of Investigator's Meeting
380(1)
Metrics
381(1)
Management of Intercontinental Planning
382(3)
Conclusion
385(1)
References
385(1)
Appendices
386(5)
Index 391

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