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Drug Products for Clinical Trials, Second Edition : Drugs and the Pharmaceutical Sciences - Donald Monkhouse

Drug Products for Clinical Trials, Second Edition

Drugs and the Pharmaceutical Sciences

By: Donald Monkhouse (Editor), Charles F. Carney (Editor), Jim Clark (Editor), Peter Brun (Editor)

Hardcover Published: 9th November 2005
ISBN: 9780824754624
Number Of Pages: 399

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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. It offers authoritative chapters by esteemed researchers and consultants in industry on the current and evolving state of clinical supplies operations. Tracking emerging trends and the development of new technologies, this Second Edition helps the CTMP operate effectively in the international sphere and reviews regulatory processes for drug approvals in the United States and Europe.

"This practical guideoffer[s] authoritative evaluations of the scientific & legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies." -Unlisted Drugs (for previous edition) "very comprehensive on the subject and give[s] a lot of "how-to" information. "very well written and very much geared towards the US market and Food and Drug Administration requirements." -European Journal of Parenteral Sciences (for previous edition) "describes both the science and the management of product development and furnishes effective approaches for preclinical drug discovery." -BOOKNews on the Internet (for previous edition)

Prefacep. iii
Contributorsp. xv
The Clinical Trials Material Professional: A Changing Rolep. 1
Introductionp. 1
Administrative/Organizational Rolep. 6
Outside Influencesp. 10
Conclusionsp. 19
Referencesp. 19
Discovery and Formulation Trends for the Clinical Trials Material Professionalp. 21
Discovery Trendsp. 21
Physicochemical Characterizationp. 30
Dissolution and Absorptionp. 34
Alternate Routes of Administrationp. 39
Biologicalsp. 44
Drug Delivery/Productsp. 47
Conclusionsp. 64
Referencesp. 64
Manufacturing and Clinical Medicine Trends for the Clinical Trials Material Professionalp. 69
Introductionp. 69
Manufacturing Processesp. 70
Manufacturing Trendsp. 78
Information Technologyp. 89
Clinicalp. 95
Development Considerationsp. 102
Conclusions: Considerations for the Clinical Trials Material Professionalp. 105
Referencesp. 109
Quality Assurance Systems for Global Companiesp. 111
Introductionp. 111
Research and Development Quality Systemp. 112
Global Quality Assurance for Clinical Supplies Preparationp. 122
Summary and Conclusionsp. 127
Referencesp. 127
Special Facilities for Developing, Manufacturing, and Packaging Potent or Hazardous Drug Productsp. 129
Introductionp. 129
Handling of Potent Compoundsp. 130
In-House vs. Outsourcingp. 144
Conclusionsp. 147
Referencesp. 147
Blinding of Drug Productsp. 149
What Is "Blinding"?p. 149
When Is Blinding Required?p. 150
Comparator Medicationp. 151
Methods of Blinding for Solid Oral Dosage Formsp. 157
Methods of Blinding for Oral Liquidsp. 169
Methods of Blinding for Injectable Solutions, Powder for Reconstitution, and Lyophilised Powderp. 170
Methods of Blinding for Metered Dose Inhalersp. 170
Methods of Blinding for Creams and Ointmentsp. 171
Conclusion/Summaryp. 171
Developing and Practical Uses for Interactive Voice Response Systems and Other Electronic Record Keepingp. 173
Interactive Voice Response System-Definition, Purpose, Advantages, Technology, and Considerations for Global Usep. 173
Developing and Implementing an In-House (Proprietary) IVRSp. 180
How to Choose an IVRS Vendor?p. 181
Integrating IVRS into the Clinical Research Protocolp. 184
Specifications and System Requirementsp. 184
Automated Record-Keeping Systemp. 188
The 21 CFR Part-11 Compliancep. 189
IVRS as a Trial Management Toolp. 190
Futurep. 195
Outsourcing Clinical Supply Materialsp. 197
Introductionp. 197
Elements of a Successful Vendor Selection Processp. 198
Contractor and Client Communication Strategiesp. 205
Appendixp. 213
Training for Clinical Trial Material (CTM) Professionalsp. 221
Introductionp. 221
Background Information for Trainersp. 224
CTM Training Requirementsp. 228
Training Documentationp. 231
Training Ideasp. 231
Training Assessmentp. 233
Conclusionp. 233
Referencesp. 235
Appendicesp. 236
Inhalation Products in Clinical Trialsp. 253
Introductionp. 253
The Drug Productp. 255
Regulatoryp. 262
Preclinical Product Developmentp. 264
Manufacturing and Packagingp. 268
Quality Controlp. 271
Animal Toxicology Testingp. 273
Clinical Product Developmentp. 273
Summaryp. 275
Referencesp. 275
Overseas Trialsp. 277
Introductionp. 277
World Regulatory Issuesp. 278
Overseas Trials Concerns for the Clinical Supplies Professionalp. 278
Manufacturingp. 283
International Outsourcingp. 284
Blinding Techniquesp. 285
Expiration/Retest Datingp. 287
CR/SF Packagingp. 287
BSE/TSE Concernsp. 288
Overview of (Some) Attempts at Harmonizationp. 291
Inspectionsp. 292
Product Approvalp. 299
Conclusionp. 308
Referencesp. 308
Clinical Supply Packagingp. 311
Introductionp. 311
Communication, Scheduling, and Planningp. 313
Choice of Packagep. 316
Packaging Componentsp. 324
Packaging Equipment Considerationsp. 330
In-Process Testingp. 344
Labelingp. 345
Assemblagep. 346
Documentationp. 349
Trainingp. 350
Summaryp. 350
Referencesp. 350
Project Managementp. 353
Introductionp. 353
Overview of Drug Developmentp. 355
The Steps in Drug Developmentp. 357
Principles of Project Managementp. 358
The Key Role of Project Managementp. 361
Team Member Responsibilitiesp. 362
Maintaining Vital Communicationsp. 363
Logistics of Suppliesp. 366
Clinical Trial Material (CTM) Suppliesp. 372
Management of Drug Productp. 373
Comparatorsp. 373
Management of the INDp. 378
Protocol Changes/Amendmentsp. 380
Management of Investigator's Meetingp. 380
Metricsp. 381
Management of Intercontinental Planningp. 382
Conclusionp. 385
Referencesp. 385
Appendicesp. 386
Table of Contents provided by Ingram. All Rights Reserved.

ISBN: 9780824754624
ISBN-10: 082475462X
Series: Drugs and the Pharmaceutical Sciences
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 399
Published: 9th November 2005
Publisher: TAYLOR & FRANCIS
Country of Publication: US
Dimensions (cm): 23.67 x 16.0  x 2.46
Weight (kg): 0.7
Edition Number: 2
Edition Type: New edition