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Formulation and Device Lifecycle Management of Biotherapeutics

Formulation and Device Lifecycle Management of Biotherapeutics

Pages: 228

Publisher: Academic Press

Year of Publication: 2022

Author(s) : Beate Bittner, Johannes Schmidt

Book Description:

The increasing pressure on healthcare costs and resources, particularly for biopharmaceuticals that require parenteral administration, has intensified the need for efficient medical management. The COVID-19 pandemic has further highlighted the value of drug delivery technologies in enabling flexible care settings. Such settings allow patients and their caregivers to choose the most suitable place for drug administration based on individual preferences and capabilities. This encompasses dosing in clinics, supervised at-home dosing, and self-administration for eligible patients.

"Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers" addresses various aspects of enhancing drug delivery for biological medicines, aiming to reduce the complexity associated with parenteral administration. By doing so, it aims to improve the patient experience and optimize healthcare capacity related to drug administration. The intended audience includes multidisciplinary researchers and drug developers from the pharmaceutical industry, biotech companies, and academia who are involved in formulation and device development. This encompasses pharmacology and medical experts responsible for generating nonclinical and clinical data to support the approval of novel dosing regimens, as well as drug delivery scientists and engineers involved in product optimizations. The discussions in the book also provide insights for professionals in market access and commercial functions, exploring the impact of patient and healthcare provider needs and country-specific reimbursement models in achieving a convenient, cost-effective, and resource-efficient drug delivery solution.

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