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Predictive Modeling Of Pharmaceutical Unit Operations

Author: Preetanshu Pandey
Publisher: Woodhead Publishing
ISBN: 0081001800
Size: 77.55 MB
Format: PDF, Docs
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The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Global Supply Chains In The Pharmaceutical Industry

Author: Nozari, Hamed
Publisher: IGI Global
ISBN: 1522559221
Size: 36.94 MB
Format: PDF, Kindle
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In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.

Continuous Processing In Pharmaceutical Manufacturing

Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527673709
Size: 24.30 MB
Format: PDF, ePub
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With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Predictive Toxicology

Author: Friedlieb Pfannkuch
Publisher: John Wiley & Sons
ISBN: 3527674209
Size: 60.94 MB
Format: PDF, ePub, Docs
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Tailored to the needs of scientists developing drugs, chemicals, cosmetics and other products this one-stop reference for medicinal chemists covers all the latest developments in the field of predictive toxicology and its applications in safety assessment. With a keen emphasis on novel approaches, the topics have been tackled by selected expert scientists, who are familiar with the theoretical scientific background as well as with the practical application of current methods. Emerging technologies in toxicity assessment are introduced and evaluated in terms of their predictive power, with separate sections on computer predictions and simulation methods, novel in vitro systems including those employing stem cells, toxicogenomics and novel biomarkers. In each case, the most promising methods are discussed and compared to classical in vitro and in vivo toxicology assays. Finally, an outlook section discusses such forward-looking topics as immunotoxicology assessment and novel regulatory requirements. With its wealth of methodological knowledge and its critical evaluation of modern approaches, this is a valuable guide for toxicologists working in pharmaceutical development, as well as in safety assessment and the regulation of drugs and chemicals.

Proceedings Of The 8th International Conference On Foundations Of Computer Aided Process Design

Author:
Publisher: Elsevier
ISBN: 0444634428
Size: 38.44 MB
Format: PDF, Mobi
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This volume collects together the presentations at the Eighth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2014, an event that brings together researchers, educators, and practitioners to identify new challenges and opportunities for process and product design. The chemical industry is currently entering a new phase of rapid evolution. The availability of low-cost feedstocks from natural gas is causing renewed investment in basic chemicals in the OECD, while societal pressures for sustainability and energy security continue to be key drivers in technology development and product selection. This dynamic environment creates opportunities to launch new products and processes and to demonstrate new methodologies for innovation, synthesis and design. FOCAPD-2014 fosters constructive interaction among thought leaders from academia, industry, and government and provides a showcase for the latest research in product and process design. Focuses exclusively on the fundamentals and applications of computer-aided design for the process industries. Provides a fully archival and indexed record of the FOCAPD14 conference Aligns the FOCAPD series with the ESCAPE and PSE series

Chemical Engineering In The Pharmaceutical Industry

Author: David J. am Ende
Publisher: John Wiley & Sons
ISBN: 1118088107
Size: 24.41 MB
Format: PDF, Kindle
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This book deals with various unique elements in the drugdevelopment process within chemical engineering science andpharmaceutical R&D. The book is intended to be used as aprofessional reference and potentially as a text book reference inpharmaceutical engineering and pharmaceutical sciences. Many of theexperimental methods related to pharmaceutical process developmentare learned on the job. This book is intended to provide many ofthose important concepts that R&D Engineers and manufacturingEngineers should know and be familiar if they are going to besuccessful in the Pharmaceutical Industry. These include basicanalytics for quantitation of reaction components– oftenskipped in ChE Reaction Engineering and kinetics books. In additionChemical Engineering in the Pharmaceutical Industryintroduces contemporary methods of data analysis for kineticmodeling and extends these concepts into Quality by Designstrategies for regulatory filings. For the current professionals,in-silico process modeling tools that streamlineexperimental screening approaches is also new and presented here.Continuous flow processing, although mainstream for ChE, is uniquein this context given the range of scales and the complex economicsassociated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts.These parts will address the fundamentals of analytical techniquesfor engineers, thermodynamic modeling, and finally provides anappendix with common engineering tools and examples of theirapplications.

21st European Symposium On Computer Aided Process Engineering

Author:
Publisher: Elsevier
ISBN: 0444538968
Size: 32.69 MB
Format: PDF, ePub, Mobi
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The European Symposium on Computer Aided Process Engineering (ESCAPE) series presents the latest innovations and achievements of leading professionals from the industrial and academic communities. The ESCAPE series serves as a forum for engineers, scientists, researchers, managers and students to present and discuss progress being made in the area of computer aided process engineering (CAPE). European industries large and small are bringing innovations into our lives, whether in the form of new technologies to address environmental problems, new products to make our homes more comfortable and energy efficient or new therapies to improve the health and well being of European citizens. Moreover, the European Industry needs to undertake research and technological initiatives in response to humanity's "Grand Challenges," described in the declaration of Lund, namely, Global Warming, Tightening Supplies of Energy, Water and Food, Ageing Societies, Public Health, Pandemics and Security. Thus, the Technical Theme of ESCAPE 21 will be "Process Systems Approaches for Addressing Grand Challenges in Energy, Environment, Health, Bioprocessing & Nanotechnologies."