Drug products for clinical trials:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York [u.a.]
Taylor & Francis
2006
|
| Edition: | 2. ed. |
| Series: | Drugs and the pharmaceutical sciences
147 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XVI, 399 S. Ill. |
| ISBN: | 082475462X 9780824754624 |
Staff View
MARC
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| 650 | 4 | |a Médicaments - Essais cliniques | |
| 650 | 4 | |a Clinical Trials as Topic |x standards | |
| 650 | 4 | |a Drug Industry |x standards | |
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Record in the Search Index
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| adam_text | Contents
Preface .... Hi
Contributors .... .vv
1. The Clinical Trials Material Professional:
A Changing Role /
Donald C. Monkhouse
Introduction .... 1
Administrative/Organizational Role .... 6
Outside Influences .... 10
Conclusions .... 19
References .... 19
2. Discovery and Formulation Trends for the Clinical
Trials Material Professional 21
Donald C. Monkhouse
Discovery Trends .... 21
Physicochemical Characterization .... 30
Dissolution and Absorption .... 34
Alternate Routes of Administration .... 39
Biologicals .... 44
Drug Delivery/Products .... 47
Conclusions .... 64
References .... 64
ix
x Contents
3. Manufacturing and Clinical Medicine Trends for the Clinical
Trials Material Professional 69
Donald C. Monkhouse
Introduction .... 69
Manufacturing Processes .... 70
Manufacturing Trends .... 78
Information Technology .... 89
Clinical .... 95
Development Considerations .... 102
Conclusions: Considerations for the Clinical
Trials Material Professional .... 105
References .... 109
4. Quality Assurance Systems for Global Companies Ill
Mabel Fernandez and Ute Lehmann
Introduction .... Ill
Research and Development Quality System .... 112
Global Quality Assurance for Clinical
Supplies Preparation .... 122
Summary and Conclusions .... 127
References .... 127
5. Special Facilities for Developing, Manufacturing, and
Packaging Potent or Hazardous Drug Products 129
Doug Grevatt and Christopher E. Lockwood
Introduction .... 129
Handling of Potent Compounds .... 130
In House vs. Outsourcing .... 144
Conclusions .... 147
References .... 147
6. Blinding of Drug Products 149
Peter Brun
What Is Blinding ? .... 149
When Is Blinding Required? .... 150
Comparator Medication .... 151
Methods of Blinding for Solid Oral Dosage Forms .... 157
Methods of Blinding for Oral Liquids .... 169
Methods of Blinding for Injectable Solutions, Powder
for Reconstitution, and Lyophilised Powder .... 170
Contents xi
Methods of Blinding for Metered Dose Inhalers .... 170
Methods of Blinding for Creams and Ointments .... 171
Conclusion/Summary .... 171
7. Developing and Practical Uses for Interactive Voice Response
Systems and Other Electronic Record Keeping 173
Charles Gettis and Jennifer Nydell
Interactive Voice Response System—Definition, Purpose,
Advantages, Technology, and Considerations
for Global Use .... 173
Developing and Implementing an In House (Proprietary)
IVRS .... 180
How to Choose an IVRS Vendor? .... 181
Integrating IVRS into the Clinical
Research Protocol .... 184
Specifications and System Requirements .... 184
Automated Record Keeping System .... 188
The 21 CFR Part 11 Compliance .... 189
IVRS as a Trial Management Tool .... 190
Future .... 195
8. Outsourcing Clinical Supply Materials 197
Michael Hardy and Eugene J. McNally
Introduction .... 197
Elements of a Successful Vendor Selection Process .... 198
Contractor and Client Communication Strategies .... 205
Appendix .... 213
9. Training for Clinical Trial Material (CTM)
Professionals 221
Jeri Weigand
Introduction .... 221
Background Information for Trainers .... 224
CTM Training Requirements .... 228
Training Documentation .... 231
Training Ideas ... 231
Training Assessment .... 233
Conclusion .... 233
References .... 235
Appendices .... 236
xii Contents
10. Inhalation Products in Clinical Trials 253
Lynn Van Campen
Introduction .... 253
The Drug Product .... 255
Regulatory .... 262
Preclinical Product Development .... 264
Manufacturing and Packaging .... 268
Quality Control .... 271
Animal Toxicology Testing .... 273
Clinical Product Development .... 273
Summary .... 275
References .... 275
11. Overseas Trials 277
Diane Mustafa, Frank Reale, and Steven Jacobs
Introduction .... 277
World Regulatory Issues .... 278
Overseas Trials Concerns for the Clinical
Supplies Professional .... 278
Manufacturing .... 283
International Outsourcing .... 284
Blinding Techniques .... 285
Expiration/Retest Dating .... 287
CR/SF Packaging .... 287
BSE/TSE Concerns .... 288
12. Overview of (Some) Attempts
at Harmonization 291
Alan G. Minsk and David L. Hoffman
Inspections .... 292
Product Approval .... 299
Conclusion .... 308
References .... 308
13. Clinical Supply Packaging 311
Dorothy M. Dolfini and Frank J. Tiano
Introduction .... 311
Communication, Scheduling, and Planning .... 313
Choice of Package .... 316
Packaging Components .... 324
Contents xiii
Packaging Equipment Considerations .... 330
In Process Testing .... 344
Labeling .... 345
Assemblage .... 346
Documentation .... 349
Training .... 350
Summary .... 350
References .... 350
14. Project Management 353
Jim Krupa
Introduction .... 353
Overview of Drug Development .... 355
The Steps in Drug Development .... 357
Principles of Project Management .... 358
The Key Role of Project Management .... 361
Team Member Responsibilities .... 362
Maintaining Vital Communications .... 363
Logistics of Supplies .... 366
Clinical Trial Material (CTM) Supplies .... 372
Management of Drug Product .... 373
Comparators .... 373
Management of the IND .... 378
Protocol Changes/Amendments .... 380
Management of Investigator s Meeting .... 380
Metrics .... 381
Management of Intercontinental Planning .... 382
Conclusion .... 385
References .... 385
Appendices .... 386
Index .... 391
|
| adam_txt |
Contents
Preface . Hi
Contributors . .vv
1. The Clinical Trials Material Professional:
A Changing Role /
Donald C. Monkhouse
Introduction . 1
Administrative/Organizational Role . 6
Outside Influences . 10
Conclusions . 19
References . 19
2. Discovery and Formulation Trends for the Clinical
Trials Material Professional 21
Donald C. Monkhouse
Discovery Trends . 21
Physicochemical Characterization . 30
Dissolution and Absorption . 34
Alternate Routes of Administration . 39
Biologicals . 44
Drug Delivery/Products . 47
Conclusions . 64
References . 64
ix
x Contents
3. Manufacturing and Clinical Medicine Trends for the Clinical
Trials Material Professional 69
Donald C. Monkhouse
Introduction . 69
Manufacturing Processes . 70
Manufacturing Trends . 78
Information Technology . 89
Clinical . 95
Development Considerations . 102
Conclusions: Considerations for the Clinical
Trials Material Professional . 105
References . 109
4. Quality Assurance Systems for Global Companies Ill
Mabel Fernandez and Ute Lehmann
Introduction . Ill
Research and Development Quality System . 112
Global Quality Assurance for Clinical
Supplies Preparation . 122
Summary and Conclusions . 127
References . 127
5. Special Facilities for Developing, Manufacturing, and
Packaging Potent or Hazardous Drug Products 129
Doug Grevatt and Christopher E. Lockwood
Introduction . 129
Handling of Potent Compounds . 130
In House vs. Outsourcing . 144
Conclusions . 147
References . 147
6. Blinding of Drug Products 149
Peter Brun
What Is "Blinding"? . 149
When Is Blinding Required? . 150
Comparator Medication . 151
Methods of Blinding for Solid Oral Dosage Forms . 157
Methods of Blinding for Oral Liquids . 169
Methods of Blinding for Injectable Solutions, Powder
for Reconstitution, and Lyophilised Powder . 170
Contents xi
Methods of Blinding for Metered Dose Inhalers . 170
Methods of Blinding for Creams and Ointments . 171
Conclusion/Summary . 171
7. Developing and Practical Uses for Interactive Voice Response
Systems and Other Electronic Record Keeping 173
Charles Gettis and Jennifer Nydell
Interactive Voice Response System—Definition, Purpose,
Advantages, Technology, and Considerations
for Global Use . 173
Developing and Implementing an In House (Proprietary)
IVRS . 180
How to Choose an IVRS Vendor? . 181
Integrating IVRS into the Clinical
Research Protocol . 184
Specifications and System Requirements . 184
Automated Record Keeping System . 188
The 21 CFR Part 11 Compliance . 189
IVRS as a Trial Management Tool . 190
Future . 195
8. Outsourcing Clinical Supply Materials 197
Michael Hardy and Eugene J. McNally
Introduction . 197
Elements of a Successful Vendor Selection Process . 198
Contractor and Client Communication Strategies . 205
Appendix . 213
9. Training for Clinical Trial Material (CTM)
Professionals 221
Jeri Weigand
Introduction . 221
Background Information for Trainers . 224
CTM Training Requirements . 228
Training Documentation . 231
Training Ideas . 231
Training Assessment . 233
Conclusion . 233
References . 235
Appendices . 236
xii Contents
10. Inhalation Products in Clinical Trials 253
Lynn Van Campen
Introduction . 253
The Drug Product . 255
Regulatory . 262
Preclinical Product Development . 264
Manufacturing and Packaging . 268
Quality Control . 271
Animal Toxicology Testing . 273
Clinical Product Development . 273
Summary . 275
References . 275
11. Overseas Trials 277
Diane Mustafa, Frank Reale, and Steven Jacobs
Introduction . 277
World Regulatory Issues . 278
Overseas Trials Concerns for the Clinical
Supplies Professional . 278
Manufacturing . 283
International Outsourcing . 284
Blinding Techniques . 285
Expiration/Retest Dating . 287
CR/SF Packaging . 287
BSE/TSE Concerns . 288
12. Overview of (Some) Attempts
at Harmonization 291
Alan G. Minsk and David L. Hoffman
Inspections . 292
Product Approval . 299
Conclusion . 308
References . 308
13. Clinical Supply Packaging 311
Dorothy M. Dolfini and Frank J. Tiano
Introduction . 311
Communication, Scheduling, and Planning . 313
Choice of Package . 316
Packaging Components . 324
Contents xiii
Packaging Equipment Considerations . 330
In Process Testing . 344
Labeling . 345
Assemblage . 346
Documentation . 349
Training . 350
Summary . 350
References . 350
14. Project Management 353
Jim Krupa
Introduction . 353
Overview of Drug Development . 355
The Steps in Drug Development . 357
Principles of Project Management . 358
The Key Role of Project Management . 361
Team Member Responsibilities . 362
Maintaining Vital Communications . 363
Logistics of Supplies . 366
Clinical Trial Material (CTM) Supplies . 372
Management of Drug Product . 373
Comparators . 373
Management of the IND . 378
Protocol Changes/Amendments . 380
Management of Investigator's Meeting . 380
Metrics . 381
Management of Intercontinental Planning . 382
Conclusion . 385
References . 385
Appendices . 386
Index . 391 |
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| spelling | Drug products for clinical trials ed. by Donald Monkhouse ... 2. ed. New York [u.a.] Taylor & Francis 2006 XVI, 399 S. Ill. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 147 Drug Industry standards Clinical Trials standards Quality Control Médicaments - Essais cliniques Clinical Trials as Topic standards Drugs Testing Klinische Prüfung (DE-588)4031192-2 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Klinische Prüfung (DE-588)4031192-2 s DE-604 Monkhouse, Donald C. Sonstige oth Drugs and the pharmaceutical sciences 147 (DE-604)BV000002008 147 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014854728&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
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| subject_GND | (DE-588)4031192-2 (DE-588)4143413-4 |
| title | Drug products for clinical trials |
| title_auth | Drug products for clinical trials |
| title_exact_search | Drug products for clinical trials |
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| title_full_unstemmed | Drug products for clinical trials ed. by Donald Monkhouse ... |
| title_short | Drug products for clinical trials |
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