Formulation And Device Lifecycle Management Of Biotherapeutics
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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
Drug Delivery Devices And Therapeutic Systems
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Author : Eric Chappel
language : en
Publisher: Academic Press
Release Date : 2020-11-07
Drug Delivery Devices And Therapeutic Systems written by Eric Chappel and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-07 with Medical categories.
Drug Delivery Devices and Therapeutic Systems examines the current technology and innovations moving drug delivery systems (DDS) forward. The book provides an overview on the therapeutic use of drug delivery devices, including design, applications, and a description of the design of each device. While other books focus on the therapy, the primary emphasis in this book is on current technologies for DDS applications, including microfluidics, nanotechnology, biodegradable hydrogel and microneedles, with a special emphasis on wearable DDS. As part of the Developments in Biomedical Engineering and Bioelectronics series, this book is written by experts in the field and informed with information directly from manufacturers. Pharmaceutical scientists, medical researchers, biomedical engineers and clinical professionals will find this an essential reference. - Provides essential information on the most recent drug delivery systems available - Explains current technology and its applications to drug delivery - Contains contributions from biomedical engineers, pharmaceutical scientists and manufacturers
Challenges In Protein Product Development
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Author : Nicholas W. Warne
language : en
Publisher: Springer
Release Date : 2018-07-22
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 2018-07-22 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.
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Global Pharmaceutical And Biologics Regulatory Strategy Second Edition
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Author : Gloria Hall
language : en
Publisher:
Release Date : 2020-03-06
Global Pharmaceutical And Biologics Regulatory Strategy Second Edition written by Gloria Hall and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-06 with categories.
Pharmaceutical Quality By Design
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Author : Sarwar Beg
language : en
Publisher: Academic Press
Release Date : 2019-03-27
Pharmaceutical Quality By Design written by Sarwar Beg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-27 with Medical categories.
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies
State Of The Art And Emerging Technologies For Therapeutic Monoclonal Antibody Characterization Volume 2 Biopharmaceutical Characterization
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Author : John E. Schiel
language : en
Publisher: ACS Symposium
Release Date : 2016-06-24
State Of The Art And Emerging Technologies For Therapeutic Monoclonal Antibody Characterization Volume 2 Biopharmaceutical Characterization written by John E. Schiel and has been published by ACS Symposium this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-06-24 with Medical categories.
"Distributed in print by Oxford University Press."
Sterile Drug Products
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Author : Michael J. Akers
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Sterile Drug Products written by Michael J. Akers and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
Regulated Bioanalysis Fundamentals And Practice
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Author : Mario L. Rocci Jr.
language : en
Publisher: Springer
Release Date : 2017-04-24
Regulated Bioanalysis Fundamentals And Practice written by Mario L. Rocci Jr. and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-24 with Medical categories.
The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.
Biosimilarity
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2018-10-03
Biosimilarity written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-03 with Medical categories.
Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars