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Computational and Experimental Design of Biopharmaceutical Formulations

Computational and Experimental Design of Biopharmaceutical Formulations
  • Author : Vladimir I. Razinkov,Arnold McAuley,Pavan Ghattyvenkatakrishna,Deirdre Piedmonte
  • Publisher :Unknown
  • Release Date :2021-11-17
  • Total pages :230
  • ISBN : 0128173483
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Summary : Computational and Experimental Design of Biopharmaceutical Formulations outlines available experimental and computational tools. It describes a rational approach to formulation design not limited by experimental design that extends to modern methods of computational modeling. These methods include the modeling of protein structure and dynamics, and of solution properties in the presence of proteins and excipients. The chapters in this book consider computational modeling of protein-solution interactions, the design of early-stage formulation studies, the design of late-stage formulation studies, automation, high-throughput and control, design of lyophilized formulations, and emerging technologies in the future formulation development. Reviews methods for the design of biopharmaceutical formulations Considers both experimental and computational methods in concert Details design techniques specific to each step in protein formulation development Discusses the predictive power of methods used in formulation stability studies Describes and considers the potential of emerging models and experimental technologies

Strategies for Formulations Development

Strategies for Formulations Development
  • Author : Ronald Snee,Roger Hoerl
  • Publisher :Unknown
  • Release Date :2016-09-27
  • Total pages :294
  • ISBN : 9781629605302
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Summary : Strategies for Formulations Development: A Step-by-Step Guide Using JMP is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process. With this book you will be able to: Approach the development process from a strategic viewpoint with the overall end result in mind. Design screening experiments to identify components that are most important to the performance of the formulation. Design optimization experiments to identify the maximum response in the design space. Analyze both screening and optimization experiments using graphical and numerical methods. Optimize multiple criteria, such as the quality, cost, and performance of product formulations. Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%. Linking dynamic graphics with powerful statistics, JMP helps construct a visually compelling narrative to interactively share findings that are coherent and actionable by colleagues and decision makers. Using this book, you can take advantage of computer generated experiment designs when classical designs do not suffice, given the physical and economic constraints of the experiential environment. Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is unique because it provides formulation scientists with the essential information they need in order to successfully conduct formulation studies in the chemical, biotech, and pharmaceutical industries.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • Author : Feroz Jameel,Susan Hershenson
  • Publisher :Unknown
  • Release Date :2010-07-13
  • Total pages :976
  • ISBN : 9780470595879
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Summary : A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

High-Throughput Formulation Development of Biopharmaceuticals

High-Throughput Formulation Development of Biopharmaceuticals
  • Author : Vladimir I. Razinkov,Gerd Kleemann
  • Publisher :Unknown
  • Release Date :2016-09-29
  • Total pages :132
  • ISBN : 9781908818768
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Summary : High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

24th European Symposium on Computer Aided Process Engineering

24th European Symposium on Computer Aided Process Engineering
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2014-06-20
  • Total pages :1954
  • ISBN : 9780444634436
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Summary : The 24th European Symposium on Computer Aided Process Engineering creates an international forum where scientific and industrial contributions of computer-aided techniques are presented with applications in process modeling and simulation, process synthesis and design, operation, and process optimization. The organizers have broadened the boundaries of Process Systems Engineering by inviting contributions at different scales of modeling and demonstrating vertical and horizontal integration. Contributions range from applications at the molecular level to the strategic level of the supply chain and sustainable development. They cover major classical themes, at the same time exploring a new range of applications that address the production of renewable forms of energy, environmental footprints and sustainable use of resources and water.

Developability of Biotherapeutics

Developability of Biotherapeutics
  • Author : Sandeep Kumar,Satish Kumar Singh
  • Publisher :Unknown
  • Release Date :2015-11-18
  • Total pages :297
  • ISBN : 9781482246155
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Summary : Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism. The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development. This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines. The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates. In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.

Handbook of Industrial Drying

Handbook of Industrial Drying
  • Author : Arun S. Mujumdar
  • Publisher :Unknown
  • Release Date :2014-07-11
  • Total pages :1348
  • ISBN : 9781466596665
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Summary : By far the most commonly encountered and energy-intensive unit operation in almost all industrial sectors, industrial drying continues to attract the interest of scientists, researchers, and engineers. The Handbook of Industrial Drying, Fourth Edition not only delivers a comprehensive treatment of the current state of the art, but also serves as a

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher :Unknown
  • Release Date :2013-04-10
  • Total pages :300
  • ISBN : 9781908818324
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Summary : Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

Biopharmaceutics Modeling and Simulations

Biopharmaceutics Modeling and Simulations
  • Author : Kiyohiko Sugano
  • Publisher :Unknown
  • Release Date :2012-07-31
  • Total pages :520
  • ISBN : 9781118354322
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Summary : A comprehensive introduction to using modeling and simulationprograms in drug discovery and development Biopharmaceutical modeling has become integral to the design anddevelopment of new drugs. Influencing key aspects of thedevelopment process, including drug substance design, formulationdesign, and toxicological exposure assessment, biopharmaceuticalmodeling is now seen as the linchpin to a drug's future success.And while there are a number of commercially available softwareprograms for drug modeling, there has not been a single resourceguiding pharmaceutical professionals to the actual tools andpractices needed to design and test safe drugs. A guide to the basics of modeling and simulation programs,Biopharmaceutics Modeling and Simulations offerspharmaceutical scientists the keys to understanding how they workand are applied in creating drugs with desired medicinalproperties. Beginning with a focus on the oral absorption of drugs,the book discusses: The central dogma of oral drug absorption (the interplay ofdissolution, solubility, and permeability of a drug), which formsthe basis of the biopharmaceutical classification system (BCS) The concept of drug concentration How to simulate key drug absorption processes The physiological and drug property data used forbiopharmaceutical modeling Reliable practices for reporting results With over 200 figures and illustrations and a peerlessexamination of all the key aspects of drug research—includingrunning and interpreting models, validation, and compound andformulation selection—this reference seamlessly bringstogether the proven practical approaches essential to developingthe safe and effective medicines of tomorrow.

Gastrointestinal Variables and Drug Absorption

Gastrointestinal Variables and Drug Absorption
  • Author : Marival Bermejo
  • Publisher :Unknown
  • Release Date :2020-03-19
  • Total pages :206
  • ISBN : 9783039284924
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Summary : This book presents some of the state-of-the-art methods for the study of the gastrointestinal variables affecting oral drug absorption. Practical applications of new in vitro release/dissolution methods are presented, as well as in vitro permeability studies to explore segmental differences. The application of MRI methods for the study of colon physiology is presented to illustrate its potential applications in controlled release dosage form design. Some examples of successful in vitro–in vivo correlations show how implementing the gastrointestinal physiological variables in the new in vitro methods can improve the predictions of in vivo drug product performance. The book contains an updated review of the experimental, computational, and in vivo approaches for measuring intestinal permeability.

The Directory of Graduate Studies

The Directory of Graduate Studies
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1996
  • Total pages :229
  • ISBN : STANFORD:36105020039595
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Summary :

Which Degree in Britain

Which Degree in Britain
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1997
  • Total pages :229
  • ISBN : UCAL:$B337544
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Summary : A comprehensive guide to full-time degree courses, institutions and towns in Britain.

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain
  • Publisher :Unknown
  • Release Date :2019-03-27
  • Total pages :448
  • ISBN : 9780128163726
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Summary : 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

European Research Centres: A-N

European Research Centres: A-N
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1994-11
  • Total pages :1219
  • ISBN : 1561591173
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Summary :

Encyclopedia Of Biopharma- Ceutical Statistics

Encyclopedia Of Biopharma- Ceutical Statistics
  • Author : Shein-Chung Chow
  • Publisher :Unknown
  • Release Date :2000
  • Total pages :535
  • ISBN : UOM:39015050146177
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Summary : "This reference covers all key topics for evaluation of data at critical stages in the pharmaceutical research and development process - highlighting the vital areas of statistical design and regulatory requirements." "Each entry of the Encyclopedia includes: self-contained, self-explanatory, and accessible data to nonbiostatisticians; "real-world" examples of statistical design and practice in the pharmaceutical industry; thoroughly up-to-date standards on good laboratory practice (GLP), good clinical practice (GCP), current good manufacturing practice (cGMP), and good statistics practice (GSP)." "Written by over 75 acclaimed international experts, the Encyclopedia of Biopharmaceutical Statistics explores interrelations among physiochemical properties of drugs in dosage form and their pharmacological, toxicological, and clinical effects; elucidates new applications of computer telephony technology; surveys the crucial relationship of the Food and Drug Administration (FDA) to pharmaceutical development, clinical trials and testing, and marketing; showcases monoclonal antibodies, cytokines, hematopoietic growth factors, tumor vaccines, xenotherapies, and cell-selection devices; describes one-sided equivalence and noninferiority trials; investigates genetic toxicology tests and other animal studies; illustrates assay technologies measuring gravimetric mass, potency, and physical or biological properties of analytes; discusses proposals for internationally standardized systems of data collection and analysis; and supplies vital economic data on factors such as reference-based pricing, burden-of-illness studies, cost-utility analysis, and cost-benefit analysis." "Containing over 2200 references, equations, tables, and drawings, the Encyclopedia of Biopharmaceutical Statistics serves as a reference for biostatisticians, chemists, pharmaceutical scientists, clinical researchers, and development pharmacists in the pharmaceutical industry and regulatory agencies, as well as upper-level undergraduate and graduate students in these disciplines."--BOOK JACKET.Title Summary field provided by Blackwell North America, Inc. All Rights Reserved

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
  • Author : Preetanshu Pandey,Rahul Bharadwaj
  • Publisher :Unknown
  • Release Date :2016-09-26
  • Total pages :464
  • ISBN : 9780081001806
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Summary : 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

Statistical Theory and Method Abstracts

Statistical Theory and Method Abstracts
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2000
  • Total pages :229
  • ISBN : UCBK:C078288404
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Summary :

Directory of Postgraduate Studies 2002

Directory of Postgraduate Studies 2002
  • Author : Hobsons Publishing, PLC
  • Publisher :Unknown
  • Release Date :2001
  • Total pages :1720
  • ISBN : UOM:39015042256373
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Summary :

the worldwide biotech industry reporting service

the worldwide biotech industry reporting service
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2002
  • Total pages :229
  • ISBN : NLI:31197064237842
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Summary :

Papers Presented at the ... Meeting

Papers Presented at the ... Meeting
  • Author : American Chemical Society. Division of Polymer Chemistry
  • Publisher :Unknown
  • Release Date :1999
  • Total pages :229
  • ISBN : UOM:39015051231242
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Summary :

Oral Controlled Release Formulation Design and Drug Delivery

Oral Controlled Release Formulation Design and Drug Delivery
  • Author : Hong Wen,Kinam Park
  • Publisher :Unknown
  • Release Date :2011-01-14
  • Total pages :376
  • ISBN : 1118060326
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Summary : This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.