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Formulation and Device Lifecycle Management of Biotherapeutics
A Guidance for Researchers and Drug Developers
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Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the broader multidisciplinary aspects of drug delivery to understand why, when and how formulation device lifecycle management should be considered. Books on drug delivery improvements typically cover the technical aspects (i.e., mode of action of novel technology, technical development), however, with the increasing pressure on healthcare costs and resources, there is awareness that on top of technical considerations, the nonclinical and clinical development pathway, regulatory requirements, and other aspects that impact access to treatments are increasingly considered. Sections cover how drug delivery improvements for biotherapeutics reduce dosing complexity, how they can improve access to medicines, and how to enable a flexible care setting. Additional sections cover how to improve drug delivery in existing treatments, how to enable flexible care settings for biotherapeutics in oncology, and more. Case studies illustrate main points across topics. Provides guidance on when and how to conduct Formulation and Device Lifecycle Management for biotherapeutics Shares concepts on nonclinical and clinical development pathways for marketed or biotherapeutics in late stage development Explains prerequisites for successful Formulation and Device Lifecycle Management based on different precedents
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