Contents:

Chapter 1 Clinical Trial Supplies – The Essential Ingredients By Dr Patricia Lobo, Technomark Consulting Services 1. Introduction 2. CTS, a Definition 3. Outsourcing 4. Clinical Trials Supplies, Activities 4.1 Manufacturing 4.2 Packing 4.3 Labelling 4.4 Storage, Warehousing and Distribution 4.5 Reconciliation and Destruction of CTS 4.6 Process Improvement 4.7 Quality 5. The Market for CTS 5.1 CTSO, a Definition 5.2 Location 5.3 Classification of CTSOs 5.4 Growing the CTS Business 5.5 Annual Revenue of CTSOs 5.6 Number of Employees of CTSOs 5.7 CTSO Facilities and Global Scope 5.8 Clinical Trial Supply Services 6. Client Survey 6.1 Why Outsource Clinical Trial Supplies 6.2 Criteria for Choosing a CTSO 6.3 CTS Services Availablitity 7. Forecasting CTS Business – the Challenge Chapter 2 Development, Formulation and Manufacture of Investigational Medicinal Products By John DR Jolly, FRPharmS, FIQA 1. Introduction 2. Drug Discovery 2.1 Stages in the Development of New Medicines 2.2 Chemical, Pharmaceutical and Biological Screening 2.3 Pre-clinical Toxicological Testing 3. Formulation of Dose Form 3.1 Pre-formulation 3.2 Modified Release Dosage Forms 3.3 Drug Pharmacokinetics 3.4 Product Specification 3.5 Stability Testing 4. Manufacture of Investigational Medicinal Product 4.1 Regulatory Framework 4.2 Quality Characteristics 4.3 Good Manufacturing Practice Chapter 3 The Role of Analytical Development in CTS By Geoff Carr PhD, Patheon Inc 1. Introduction 2. Regulatory Considerations 3. Development of Appropriate Analytical Methodologies 3.1 Analytical Methods for Phase I Clinical Trial Materials 3.2 Analytical Methods for Phase II and III Clinical Trial Materials 3.2.1 Excipient Compatibility Studies 3.2.2 High Performance Liquid Chromatography 3.2.3 Pharmaceutical Performance 3.2.4 Feasibility Batches 3.2.5 Verification of Cleaning Methods 4. Validation of Analytical Methodologies 5. Stability Programs 6. Placebo Formulations 7. Blinded Clinical Comparators Chapter 4 Packaging Types By Nicola Mountjoy, Aptuit 1. Introduction 2. Technical 2.1 Primary Packaging 2.1.1 Blistering/Foils 2.1.2 Bottling 2.1.3 Child Resistant Packaging 2.2 Secondary Packaging 2.2.1 Blinding 2.2.2 Assembly 2.3 Labelling 2.3.1 Application 2.3.2 Standard/Booklets/JIT 2.3.3 Labelling at Controlled temperature 3. Summary Chapter 5 CTS – The Regulatory Challenge By Keren Winmill, Penn Pharmaceutical Services 1. Introduction 2. History 3. The Regulatory Framework in Europe 4. Interpretation of European Requirements 4.1 Clinical Trial Applications/Ethics 4.2 The Role of the Qualified Person 4.3 Manufacturing Authorisation 4.4 Product Specification File 4.5 Label Requirements 4.6 Expiry Dating 4.7 Importation into Europe 4.8 GMP 4.9 Inspections 5. United States 5.1 Regulations and Guidances 5.2 Label Requirements 5.3 Child Resistant Packaging 6. Active Pharmaceutical Ingredient 7. Compassionate Use and Named Patient Supply 8. Drug Device Combinations 9. Conclusions Chapter 6 Automated Logistics and Distribution By Anthony Frankland, Fisher Clinical Services 1. Introduction 2. The Clinical Trials Environment and Implications for Clinical Supplies 2.1 Major Pharmaceutical Companies 2.2 Biotechnology 2.3 Commercialisation of Biopharm Products 2.4 European Union Expansion 2.5 IVR Driven Studies 2.6 Consolidation of Clinical Supplies 2.7 Summary of Implications 3. The Application of Technology and Automation in Clinical Distribution 3.1 Receipt and Processing of Distribution Orders 3.2 Picking and Packing of Orders 3.3 Couriers and Web Technology 4. The Use of Information Technology to Optimise the Supply Plan 5. The Extension of IVR Technology 6. Trial Simulation and Forecasting Chapter 7 Supplying the Needs of Emerging Markets By Richard Shannon, Clinical Trial Services - Almac 1. Introduction 2. Why Perform Clinical Trials in Emerging Markets 3. Which Regions are Considered Emerging Markets? 3.1 Asia 3.2 India 3.3 Central and Eastern Europe 3.4 Latin America 3.5 Africa 4. Logistical Challenges 5. Selection of Market Partners 6. Obtaining Import Licences 7. Use of Strategic Distribution Depots 7.1 Direct to Site Distribution 7.2 Distribution to Local Depots 7.3 Hybrid Approaches 8. Cold Chain Management 8.1 Packaging for Maintenance of Temperature Control 8.2 Use of Monitoring Devices 8.3 Transit Times 8.4 Planning for Deviations 9. Conclusion Chapter 8 A Note on Scheduling, Planning and Project Management By Alistair Black, Aptuit 1. Planning for CTS 2. The Phases of a Project 2.1 Initiation 2.2 Specification 2.3 Design 2.4 Implementation/Operations 3. Risk Analysis 3.1 Identify the Risks 4. Milestones 5. Controlling Projects 5.1 Taking action