Development of biopharmaceutical parenteral dosage forms,
Автор: Regine Eibl, Dieter Eibl Название: Single-use technology in biopharmaceutical manufacture ISBN: 1119477832 ISBN-13(EAN): 9781119477839 Издательство: Wiley Рейтинг: Цена: 23435.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals
The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors--noted experts on the topic--provide the essential information on the principles, characteristics, engineering aspects, economics, and applications.
This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals' applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book:
- Contains an updated and end-to-end view of the development and manufacturing of single-use biologics
- Helps in the identification of appropriate disposables and relevant vendors
- Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences
- Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies
Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Описание: This innovative reference provides a coherent and critical view on the potential benefits of a transition from batch to continuous processes in the biopharmaceutical industry, with the main focus on chromatography. It also covers the key topics of protein stability and protein conjugation, addressing the chemical reaction and purification aspects together with their integration. This book offers a fine balance between theoretical modelling and illustrative case studies, between fundamental concepts and applied examples from the academic and industrial literature. Scientists interested in the design of biopharmaceutical processes will find useful practical methodologies, in particular for single-column and multi-column chromatographic processes.
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: 13974.00 р. 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: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S Название: Quality by Design for Biopharmaceutical Drug Product Development ISBN: 1493951521 ISBN-13(EAN): 9781493951529 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.
Автор: Chin Jane Y., Chin J. Y. Название: Practical Leadership for Biopharmaceutical Executives ISBN: 0081017332 ISBN-13(EAN): 9780081017333 Издательство: Elsevier Science Рейтинг: Цена: 20191.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity.
Focuses on personal leadership, where the executive has an opportunity to manage his/her own effectiveness as a leader and manager, and engage with their own career development and method of contribution within their chosen industry
Discusses particularly the unique leadership challenges in biohealthcare: an industry that is at once highly innovative and emotive. Biohealthcare companies are often viewed with suspicion by the consumers who question corporate motives, and product marketing and sales practices. The effective biohealthcare leaders are well aware of these emotive features, and embody ethics through action - not just lip service
Includes real life examples, including a series of both phone-based and email-based interviews of executives
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: 12577.00 р. 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: Lanju Zhang; Ding-Geng (Din) Chen; Hongmei Jiang; Название: Contemporary Biostatistics with Biopharmaceutical Applications ISBN: 3030153096 ISBN-13(EAN): 9783030153090 Издательство: Springer Рейтинг: Цена: 13974.00 р. 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.
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