Design Of Electromechanical And Combination Products
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Design Of Electromechanical And Combination Products
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Author : Ali Jamnia
language : en
Publisher: CRC Press
Release Date : 2023-08-31
Design Of Electromechanical And Combination Products written by Ali Jamnia and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-31 with Technology & Engineering categories.
1) Focuses on using the agile method in real world examples of electromechanical product design 2) Follows the process of design, development and manufacture of electromechanical products 3) Presents practical guidelines to produce cutting-edge product designs 4) Explores both engineering drawings and 3D modelling
The Combination Products Handbook
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Author : Susan Neadle
language : en
Publisher: CRC Press
Release Date : 2023-05-16
The Combination Products Handbook written by Susan Neadle and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-16 with Medical categories.
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.
Challenges In Protein Product Development
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Author : Nicholas W. Warne
language : en
Publisher: Springer
Release Date : 2018-06-20
Challenges In Protein Product Development written by Nicholas W. Warne and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-20 with Medical categories.
In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.
Official Gazette Of The United States Patent And Trademark Office
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Author :
language : en
Publisher:
Release Date : 2001
Official Gazette Of The United States Patent And Trademark Office written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Trademarks categories.
Reliability Engineering Of Beidou Navigation Satellite
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Author : Hui Yang
language : en
Publisher: Springer Nature
Release Date : 2024-04-29
Reliability Engineering Of Beidou Navigation Satellite written by Hui Yang and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-29 with Technology & Engineering categories.
This book describes the reliability research results and experience of BeiDou navigation satellite in engineering development. According to the characteristics of high reliability and high availability, this book discusses the reliability requirements, reliability design, reliability modeling, and reliability analysis of navigation satellite and constellation, focusing on the demonstration and decomposition of reliability requirements, constellation availability design, satellite availability design, and availability analysis. Based on the characteristics of batch production of navigation satellites, the particularity of reliability work is analyzed, and the reliability assurance works during batch production such as process reliability, data consistency comparison, storage reliability, and redundant satellite demonstration are introduced. This book is suitable for spacecraft developers, as well as postgraduates majoring in spacecraft engineering, quality, or reliability.
Nasa Tech Briefs
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Author :
language : en
Publisher:
Release Date : 2004
Nasa Tech Briefs written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Technology categories.
Advanced Manufacturing Systems Icmse 2011
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Author : Dao Guo Yang
language : en
Publisher: Trans Tech Publications Ltd
Release Date : 2011-02-21
Advanced Manufacturing Systems Icmse 2011 written by Dao Guo Yang and has been published by Trans Tech Publications Ltd this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-02-21 with Technology & Engineering categories.
Selected, peer reviewed papers from the International Conference on Manufacturing Science and Engineering (ICMSE 2011), 9-11 April, 2011, Guilin, China
Engineering Science And Computer Jobs
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Author :
language : en
Publisher:
Release Date : 1984
Engineering Science And Computer Jobs written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1984 with Computer programmers categories.
Managing In The Modular Age
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Author : Raghu Garud
language : en
Publisher: John Wiley & Sons
Release Date : 2009-02-09
Managing In The Modular Age written by Raghu Garud and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-02-09 with Business & Economics categories.
This book brings together seminal articles by leading scholars of technological and organizational systems, exploring the impact of 'modularity'. Modularity refers to an ability to take apart and put together differenct products and networks, or to 'mix and match' components in order to meet different user specifications. This is of key importance today where new systems such as the World Wide Web and many areas of the computer industry depend on it. The volume pulls together and defines an exciting new area of inquiry: into how our 'modular age' is reshaping the business eco-system. Includes contributions from leading scholars of technology and organization Modularity refers to an ability to take apart and put together different products and systems, or to 'mix and match' components in order to meet different user specifications. Consolidates and defines an area of inquiry that is becoming increasingly important with the development of web-based and 'network' industries. Sensitizes readers to the complexity of issues surrounding new modular products and systems created by e-business Encourages readers to make connections among different levels and disciplines. Initiates a debate around issues of modularity. Includes a commentary co-authored by the late Nobel Laureate Herbert A. Simon to whom the book is dedicated.
Formulation And Device Lifecycle Management Of Biotherapeutics
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Author : Beate Bittner
language : en
Publisher: Academic Press
Release Date : 2022-01-14
Formulation And Device Lifecycle Management Of Biotherapeutics written by Beate Bittner and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-14 with Medical categories.
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