The second edition of this work, now with the expanded title of Design of Electromechanical and Combination Products, covers the design and development of electromechanical products, updated throughout to focus not only on an Agile Systems approach but also its application to disposables and consumables. Providing a practical set of guidelines and thorough examination of best practices, this book focuses on cutting-edge research on sustainability of electromechanical and combination products. Key Features Presents the design, development, and life cycle management of electromechanical and combination products Provides a practical set of guidelines and best practices for world-class design Explains the role of costing and pricing in product design Covers Design for X and its role in product life-cycle management Examines the dynamics of cross-functional design and product development teams Develops DHF and DMR as tools and inherent components of configuration management Includes numerous real-world examples of electromechanical and combination product designs This book is intended for scientists, engineers, designers, and technical managers, and provides a gateway to developing a product’s design history file (DHF) and device master record (DMR). These tools enable the design team to communicate a product’s design, manufacturability, and service procedures with various cross-functional teams.

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

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

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

This basic source for identification of U.S. manufacturers is arranged by product in a large multi-volume set. Includes: Products & services, Company profiles and Catalog file.

A text for design engineers in industry and for engineering students, providing the information necessary in order to develop competitive electromechanical products for the market in the 1990s. It covers the areas of design activities, common component guidelines, design specified processes in the manufacturing equation, reliability, test, and certification issues. The emphasis throughout is on practical application and the text reflects the best current industrial practice. Note: CiP shows the title as Electromechanical Product Design. Annotation copyright by Book News, Inc., Portland, OR

Vols. for 1970-71 includes manufacturers' catalogs.

Vol. for 1955 includes an issue with title Product design handbook issue; 1956, Product design digest issue; 1957, Design digest issue.