Drug Products for Clinical Trials, Second Edition

by Monkhouse; Donald

• ISBN13: 9780824754624
• ISBN10: 082475462X
• Edition: 2nd
• Format: Hardcover
• Copyright: 2005-11-09
• Publisher: CRC Press

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