Drug Products for Clinical Trials, Second

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.

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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Drug Products for Clinical Trials, Second Edition

Summary

Table of Contents

Supplemental Materials