Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution. Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts Discusses how to realize home- and self-administration of biotherapeutics in cancer care Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities
Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution. Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts Discusses how to realize home- and self-administration of biotherapeutics in cancer care Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities
In everyday life, we generally assume that we can make our own decisions on matters which concern our own lives. We assume that a life followed only according to decisions taken by other people, against our will, cannot be a well-lived life – we assume, in other words, that we are and should be autonomous. However, it is equally true that many aspects of our lives are not chosen freely: this is true of social relations and commitments but also of all those situations we simply seem to stumble into, situations which just seem to happen to us. The possibility of both the success of an autonomous life and its failure are part of our everyday experiences. In this brilliant and illuminating book, Beate Roessler examines the tension between failing and succeeding to live an autonomous life and the obstacles we have to face when we try to live our life autonomously, obstacles within ourselves as well as those that stem from social and political conditions. She highlights the ambiguities we encounter, examines the roles of self-awareness and self-deception, explores the role of autonomy for the meaning of life, and maps out the social and political conditions necessary for autonomy. Informed by philosophical perspectives but also drawing on literary texts, such as those of Siri Hustvedt and Jane Austen, and diaries, including those of Franz Kafka and Sylvia Plath, Roessler develops a formidable defense of autonomy against excessive expectations and, above all, against overpowering skepticism.
Part of Water Quality Set - Buy all four books and save over 30% on buying separately! Bioanalytical Tools in Water Quality Assessment reviews the application of bioanalytical tools to the assessment of water quality including surveillance monitoring. The types of water included range from wastewater to drinking water, including recycled water, as well as treatment processes and advanced water treatment. Bioanalytical Tools in Water Quality Assessment not only demonstrates applications but also fills in the background knowledge in toxicology/ecotoxicology needed to appreciate these applications. Each chapter summarises fundamental material in a targeted way so that information can be applied to better understand the use of bioanalytical tools in water quality assessment. Bioanalytical tools in Water Quality Assessment can be used by lecturers teaching academic and professional courses and also by risk assessors, regulators, experts, consultants, researchers and managers working in the water sector. It can also be a reference manual for environmental engineers, analytical chemists, and toxicologists. Authors: Beate Escher, National Research Centre for Environmental Toxicology (EnTox), The University of Queensland, Australia, Frederic Leusch, Smart Water Research Facility (G51), Griffith University Gold Coast Campus, Australia. With contributions by Heather Chapman and Anita Poulsen
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