Supply chain planning for clinical trials : a practical guide

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Başlık:

Yazar:

Mills, Ryan, 1982- author.

ISBN:

9781394179572

9781394179565

9781394179589

Fiziksel Tanımlama:

1 online resource (xviii, 472 pages) : illustrations

İçerik:

Chapter 1: Introduction to Supply Chain Management -- Chapter 2: Introduction to Clinical Trials -- Chapter 3: Introduction to the Clinical Trial Supply Chain -- Chapter 4: Quality Considerations -- Chapter 5: Regulatory Considerations -- Chapter 6: RTSM and Its Role in the Clinical Supply Chain -- Chapter 7: Supply Chain Planning for Clinical Trials -- Chapter 8: Finished Product Demand Planning: Basic Concepts -- Chapter 9: Finished Product Supply Planning: The Production Plan -- Chapter 10: Finished Product Expiry Planning -- Chapter 11: Finished Product Supply Planning: The Distribution Plan -- Chapter 12: Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance -- Chapter 13: Advanced Concepts in Demand and Supply Planning -- Chapter 14: Clinical Supply Chain Reports, Budgets, and Metrics -- Chapter 15: Clinical Supply Chain Planning Processes -- Chapter 16: A Week in the Life of a Clinical Planner -- Chapter 17: Comparator and Ancillary Planning -- Chapter 18: Make-to-Order and Just-in-Time Supply Chains in Clinical Trials -- Chapter 19: Direct-to-Patient Supply Chain Management -- Chapter 20: Contract Organization Management and Oversight -- Chapter 21: International Logistics for Clinical Biopharmaceutical Products -- Chapter 22: Clinical Supply Chain Planning Tools and Technology -- Chapter 23: Integrating the Clinical Supply Chain into a Commercial Launch -- Appendix: Clinical Supply Chain Planning Data Elements and Formulas -- Glossary -- Index.

Özet:

"Before a new drug is approved for general use, its safety and usefulness has to be demonstrated in a clinical trial, in which the new therapeutic is administered to healthy and diseased volunteers under close medical supervision. These hugely expensive trials depend on a timely and efficient supply of the new drug substance. This is not trivial for the manufacturer, because at that point the drug will not yet have entered a large-scale quality-controlled production regime that is the norm for marketed drugs. Managing the timely supply of pre-production drugs to the various centers involved in a clinical trial while maintaining quality control and accountability is a critical component of every clinical trial that requires specialist knowledge and a dedicated workflow"-- Provided by publisher.

Notlar:

John Wiley and Sons

Konu Terimleri:

Drug development.

Drugs -- Testing.

Production control.

Clinical pharmacology.

Clinical trials -- Management -- Handbooks, manuals, etc.

Pharmacology, Clinical

Études cliniques -- Gestion -- Guides, manuels, etc.

Médicaments -- Développement.

Médicaments -- Essais cliniques.