Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing, Yang, Harry
Автор: Bolgar Mark S. Название: Mass Spectrometry in Biopharmaceutical and Emerging Drug Modalities ISBN: 1782629750 ISBN-13(EAN): 9781782629757 Издательство: Royal Society of Chemistry Рейтинг: Цена: 223870.00 T Наличие на складе: Невозможна поставка. Описание: The focus of this book is on the use of mass spectrometry (MS) for the assessment of alternative modes of drug efficacy and inclusion of information on the use of MS in the development of protein biosimilars.
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field
Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements.
Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future.
Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions
Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies
Includes many diagrams that clarify the design approach
Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Автор: Ting Naitee, Cappelleri Joseph C., Ho Shuyen Название: Design and Analysis of Subgroups with Biopharmaceutical Applications ISBN: 3030401049 ISBN-13(EAN): 9783030401047 Издательство: Springer Рейтинг: Цена: 83850.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry.
Автор: Becky McCuen, Charles Rutter, Gary Gilleskie Название: Biopharmaceutical Manufacturing: Principles, Processes, and Practices ISBN: 3110616874 ISBN-13(EAN): 9783110616873 Издательство: Walter de Gruyter Рейтинг: Цена: 100350.00 T Наличие на складе: Нет в наличии. Описание:
Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:
Автор: Zhang Lanju, Chen Ding-Geng (Din), Jiang Hongmei Название: Contemporary Biostatistics with Biopharmaceutical Applications ISBN: 3030153126 ISBN-13(EAN): 9783030153120 Издательство: Springer Рейтинг: Цена: 93160.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Part I Biostatistical Methodology.- Dimension Reduction in High Dimensional Multivariate Time Series Analysis.- Multi-Panel Kendall Plot Applied to Measuring Dependence.- Flexible Optimal Design Strategies.- A Multivariate Spatial Modelling Approach with Nonparametric Cross-covariogram.- A Deterministic Global Optimization Method for Variational Inference.- Part II Statistical Genetics and Bioinformatics.- Subgroup identification with latent Dirichlet allocation.- Dictionary learning based genotype imputation to improve power for association testing.- Integrating Transcriptional Time Lag Information into Gene Regulatory Network Construction.- Optimal experimental designs for fMRI when the model matrix is uncertain.- On Exact and Approximate Distributions of K-homopolymer for iid and Markov Dependent DNA Sequences.- Part III Regulatory Statistics.- Utilizing Seamless Adaptive Designs for NASH Clinical Trials.- A Bayesian Non-inferiority Design with Companion Constancy Test in Active Controlled Trials.- A Study Design for Utilizing External Data to Augment the Control in a Randomized Controlled Trial.- Some thoughts in designing a Bayesian study: From a statistical reviewer's perspective.- On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies.- Part IV Biopharmaceutical Research and Applications.-Current Status Data in the Presence of a Terminal Event.- Seamless Phase 2/3 Study Design with an Oncology Example.- A Bayesian meta-analysis method for estimating risk difference of rare events.- Comparison of multi-arm multi-stage design and adaptive randomization in platform clinical trials.- A Calibrated Power Prior Approach to Borrow Information from Historical Data with Application.- A Gatekeeping Test in a Group Sequential Design with Multiple Interim Looks.- Application of Bayesian Methods in Oncology Dose Escalation Studies with Late Onset Toxicity.- Bayesian hierarchical model estimation and comparison of immunogenicity assay cut-points.-Inference for Two-Stage Dynamic Treatment Regimes in the Presence of Drop.- Comparison of different approaches for dynamic prediction of survival using longitudinal data.- Update on progress of ASA Biopharm Safety Monitoring Working Group.- Options for implementing pattern-mixture-based sensitivity analyses.
Автор: Lanju Zhang; Ding-Geng (Din) Chen; Hongmei Jiang; Название: Contemporary Biostatistics with Biopharmaceutical Applications ISBN: 3030153096 ISBN-13(EAN): 9783030153090 Издательство: Springer Рейтинг: Цена: 93160.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications.Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.
Автор: Avis Название: Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation ISBN: 1574910167 ISBN-13(EAN): 9781574910162 Издательство: Taylor&Francis Рейтинг: Цена: 357280.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Describes practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, this book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques.
Автор: Gutka Hiten J., Yang Harry, Kakar Shefali Название: Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development ISBN: 3319996797 ISBN-13(EAN): 9783319996790 Издательство: Springer Рейтинг: Цена: 158380.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Автор: Peace Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811078254 ISBN-13(EAN): 9789811078255 Издательство: Springer Рейтинг: Цена: 102480.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: On Statistical Approaches to Meta-analysis of Randomized Clinical Trials.- Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies.- Generalized Tests in Clinical Trials.- Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free.- Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia.- Some Statistical Issues in Patient-reported Outcomes.- Network Meta-analysis.- Detecting Safety Signals Among Adverse Events in Clinical Trials.- Applied Meta-analysis using R.- Treatment of Missing Data in Comparative Effectiveness Research.- Missing Data.- Bayesian Subgroup Analysis with Examples.- Statistical Methods in Diagnostic Devices.- A Question-Based Approach to the Analysis of Safety Data.- Analysis of Two-stage Adaptive Seamless Trial Design.- Multiplicity Problems in Clinical Trials - A Regulatory Perspective.
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