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Computational and Experimental Design of Biopharmaceutical Formulations

Computational and Experimental Design of Biopharmaceutical Formulations
A Book

by Vladimir I. Razinkov,Arnold McAuley,Pavan Ghattyvenkatakrishna,Deirdre Piedmonte

  • Publisher : Academic Press
  • Release : 2021-11-17
  • Pages : 230
  • ISBN : 9780128173480
  • Language : En, Es, Fr & De
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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

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
A Book

by Feroz Jameel,Susan Hershenson

  • Publisher : John Wiley & Sons
  • Release : 2010-07-13
  • Pages : 976
  • ISBN : 0470595876
  • Language : En, Es, Fr & De
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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.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
A Book

by Damian J. Houde,Steven A. Berkowitz

  • Publisher : Elsevier
  • Release : 2019-11-13
  • Pages : 586
  • ISBN : 0444641742
  • Language : En, Es, Fr & De
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Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Strategies for Formulations Development

Strategies for Formulations Development
A Step-by-Step Guide Using JMP

by Ronald Snee,Roger Hoerl

  • Publisher : SAS Institute
  • Release : 2016-09-27
  • Pages : 294
  • ISBN : 1629605301
  • Language : En, Es, Fr & De
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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.

Cumulated Index Medicus

Cumulated Index Medicus
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1998
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Which Degree in Britain

Which Degree in Britain
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1997
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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A comprehensive guide to full-time degree courses, institutions and towns in Britain.

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
A Book

by Jelena Djuris

  • Publisher : Elsevier
  • Release : 2013-04-10
  • Pages : 300
  • ISBN : 1908818328
  • Language : En, Es, Fr & De
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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
Theory, Practice, Methods, and Applications

by Kiyohiko Sugano

  • Publisher : John Wiley & Sons
  • Release : 2012-07-31
  • Pages : 520
  • ISBN : 111835432X
  • Language : En, Es, Fr & De
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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.

The Directory of Graduate Studies

The Directory of Graduate Studies
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1996
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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European Research Centres: A-N

European Research Centres: A-N
A Book

by Anonim

  • Publisher : Stockton Press
  • Release : 1994-11
  • Pages : 1219
  • ISBN : 9781561591176
  • Language : En, Es, Fr & De
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Encyclopedia Of Biopharma- Ceutical Statistics

Encyclopedia Of Biopharma- Ceutical Statistics
A Book

by Shein-Chung Chow

  • Publisher : CRC Press
  • Release : 2000
  • Pages : 535
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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"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

AMSTAT News

AMSTAT News
A Book

by American Statistical Association

  • Publisher : Unknown Publisher
  • Release : 2000
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Directory of Postgraduate Studies 2002

Directory of Postgraduate Studies 2002
A Book

by Hobsons Publishing, PLC

  • Publisher : Unknown Publisher
  • Release : 2001
  • Pages : 1720
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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New Scientist

New Scientist
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2007
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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the worldwide biotech industry reporting service

the worldwide biotech industry reporting service
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2002
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Papers Presented at the ... Meeting

Papers Presented at the ... Meeting
A Book

by American Chemical Society. Division of Polymer Chemistry

  • Publisher : Unknown Publisher
  • Release : 1999
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Statistical Theory and Method Abstracts

Statistical Theory and Method Abstracts
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2001
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Medical Research Centres

Medical Research Centres
A World Directory of Organizations and Programmes

by Informa Healthcare

  • Publisher : Unknown Publisher
  • Release : 1995
  • Pages : 678
  • ISBN : 9781860670176
  • Language : En, Es, Fr & De
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Focuses on research and development centers in the areas of medical and biomedical sciences including those in anatomy, biochemistry, clinical medicine, dentistry, drugs, genetics, immunology, neoplasms, pharmaceutical technology, and surgery.

British universities' guide to graduate study

British universities' guide to graduate study
produced by and for the universities as the authoritative source of information on postgraduate taught courses

by Association of Commonwealth Universities

  • Publisher : Unknown Publisher
  • Release : 1985
  • Pages : 236
  • ISBN : 9780851430935
  • Language : En, Es, Fr & De
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Genetic Engineering News

Genetic Engineering News
GEN.

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2005
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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