Proceedings Of The 2015 International Conference On Medicine And Biopharmaceuticals
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Proceedings Of The 2015 International Conference On Medicine And Biopharmaceuticals
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Author :
language : en
Publisher: World Scientific
Release Date : 2016
Proceedings Of The 2015 International Conference On Medicine And Biopharmaceuticals written by and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Health & Fitness categories.
"This book provides an all-embracing review of each and every author's study on the related topics and areas. For instance, some author's study on Chinese Medicine, and some other researchers' survey on biomedical engineering. Moreover, there are also papers that focus on information based bioinformatics, pharmacy and medicinal chemistry and biopharmaceutical technology."--
Medicine And Biopharmaceutical
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Author : Masahide Takahashi
language : en
Publisher: World Scientific Publishing Company
Release Date : 2015-11
Medicine And Biopharmaceutical written by Masahide Takahashi and has been published by World Scientific Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11 with Medical categories.
This book provides an all-embracing review of each and every author's study on the related topics and areas. For instance, some author's study on Chinese Medicine, and some other researchers' survey on biomedical engineering. Moreover, there are also papers that focus on information based bioinformatics, pharmacy and medicinal chemistry and biopharmaceutical technology.
The World Of Applied Electromagnetics
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Author : Akhlesh Lakhtakia
language : en
Publisher: Springer
Release Date : 2017-08-08
The World Of Applied Electromagnetics written by Akhlesh Lakhtakia and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-08 with Technology & Engineering categories.
This book commemorates four decades of research by Professor Magdy F. Iskander (Life Fellow IEEE) on materials and devices for the radiation, propagation, scattering, and applications of electromagnetic waves, chiefly in the MHz-THz frequency range as well on electromagnetics education. This synopsis of applied electromagnetics, stemming from the life and times of just one person, is meant to inspire junior researchers and reinvigorate mid-level researchers in the electromagnetics community. The authors of this book are internationally known researchers, including 14 IEEE fellows, who highlight interesting research and new directions in theoretical, experimental, and applied electromagnetics.
Translational Medicine
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Author : Joy A. Cavagnaro
language : en
Publisher: CRC Press
Release Date : 2021-11-26
Translational Medicine written by Joy A. Cavagnaro and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-26 with Medical categories.
Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Continuous Manufacturing For The Modernization Of Pharmaceutical Production
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-04-05
Continuous Manufacturing For The Modernization Of Pharmaceutical Production written by National Academies of Sciences, Engineering, and 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 2019-04-05 with Medical categories.
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Pharmaceutical Regulatory Environment
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Author : Reem K. Al-Essa
language : en
Publisher: Springer
Release Date : 2015-05-06
Pharmaceutical Regulatory Environment written by Reem K. Al-Essa and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-05-06 with Medical categories.
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
Medical Product Safety Evaluation
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Author : Jie Chen
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Medical Product Safety Evaluation written by Jie Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Mathematics categories.
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.
Biopharmaceutical Processing
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Author : Gunter Jagschies
language : en
Publisher: Elsevier
Release Date : 2018-01-18
Biopharmaceutical Processing written by Gunter Jagschies and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-18 with Technology & Engineering categories.
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference
Fda Regulatory Affairs
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Author : David Mantus
language : en
Publisher: CRC Press
Release Date : 2014-02-28
Fda Regulatory Affairs written by David Mantus and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-02-28 with Medical categories.
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Applied Statistics In Biomedicine And Clinical Trials Design
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Author : Zhen Chen
language : en
Publisher: Springer
Release Date : 2015-05-04
Applied Statistics In Biomedicine And Clinical Trials Design written by Zhen Chen and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-05-04 with Medical categories.
This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.