Strategies For Formulations Development

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Strategies For Formulations Development
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Author : Ronald Snee
language : en
Publisher: SAS Institute
Release Date : 2016-09-14
Strategies For Formulations Development written by Ronald Snee and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-14 with Computers categories.
This book 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.
Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals
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Author : Feroz Jameel
language : en
Publisher: John Wiley & Sons
Release Date : 2010-08-09
Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals written by Feroz Jameel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-08-09 with Science categories.
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.
Strategies For Formulations Development
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Author : Ronald Snee
language : en
Publisher:
Release Date : 2019-08-30
Strategies For Formulations Development written by Ronald Snee and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-30 with Computers categories.
Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) 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 Analytical Development For Low Dose Oral Drug Products
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Author : Jack Zheng
language : en
Publisher: John Wiley & Sons
Release Date : 2009-03-04
Formulation And Analytical Development For Low Dose Oral Drug Products written by Jack Zheng and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-04 with Medical categories.
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
Innovative Dosage Forms
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Author : Yogeshwar Bachhav
language : en
Publisher: John Wiley & Sons
Release Date : 2019-12-04
Innovative Dosage Forms written by Yogeshwar Bachhav and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-04 with Science categories.
Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
Formulation And Analytical Development For Low Dose Oral Drug Products
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Author : Jack Zheng
language : en
Publisher: John Wiley & Sons
Release Date : 2009-02-09
Formulation And Analytical Development For Low Dose Oral Drug Products written by Jack Zheng and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-02-09 with Medical categories.
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
Drug Delivery Strategies For Poorly Water Soluble Drugs
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Author : Dionysios Douroumis
language : en
Publisher: John Wiley & Sons
Release Date : 2012-12-19
Drug Delivery Strategies For Poorly Water Soluble Drugs written by Dionysios Douroumis and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-19 with Science categories.
Many newly proposed drugs suffer from poor water solubility, thus presenting major hurdles in the design of suitable formulations for administration to patients. Consequently, the development of techniques and materials to overcome these hurdles is a major area of research in pharmaceutical companies. Drug Delivery Strategies for Poorly Water-Soluble Drugs provides a comprehensive overview of currently used formulation strategies for hydrophobic drugs, including liposome formulation, cyclodextrin drug carriers, solid lipid nanoparticles, polymeric drug encapsulation delivery systems, self–microemulsifying drug delivery systems, nanocrystals, hydrosol colloidal dispersions, microemulsions, solid dispersions, cosolvent use, dendrimers, polymer- drug conjugates, polymeric micelles, and mesoporous silica nanoparticles. For each approach the book discusses the main instrumentation, operation principles and theoretical background, with a focus on critical formulation features and clinical studies. Finally, the book includes some recent and novel applications, scale-up considerations and regulatory issues. Drug Delivery Strategies for Poorly Water-Soluble Drugs is an essential multidisciplinary guide to this important area of drug formulation for researchers in industry and academia working in drug delivery, polymers and biomaterials.
Strategies For Formulations Development
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Author : Ronald D. Snee
language : en
Publisher: SAS Institute
Release Date : 2016
Strategies For Formulations Development written by Ronald D. Snee and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with MATHEMATICS categories.
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.
Rational Design Of Stable Protein Formulations
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Author : John F. Carpenter
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Rational Design Of Stable Protein Formulations written by John F. Carpenter and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.
Food Formulation
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Author : Shivani Pathania
language : en
Publisher: John Wiley & Sons
Release Date : 2021-03-15
Food Formulation written by Shivani Pathania and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-15 with Technology & Engineering categories.
Reviews innovative processing techniques and recent developments in food formulation, identification, and utilization of functional ingredients Food Formulation: Novel Ingredients and Processing Techniques is a comprehensive and up-to-date account of novel food ingredients and new processing techniques used in advanced commercial food formulations. This unique volume will help students and industry professionals alike in understanding the current trends, emerging technologies, and their impact on the food formulation techniques. Contributions from leading academic and industrial experts provide readers with informed and relevant insights on using the latest technologies and production processes for new product development and reformulations. The text first describes the basis of a food formulation, including smart protein and starch ingredients, healthy ingredients such as salt and sugar replacers, and interactions within the food components. Emphasizing operational principles, the book reviews state-of-the-art 3D printing technology, encapsulation and a range of emerging technologies including high pressure, pulsed electric field, ultrasound and supercritical fluid extraction. The final chapters discuss recent developments and trends in food formulation, from foods that target allergies and intolerance, to prebiotic and probiotic food formulation designed to improve gut health. A much-needed reference on novel sourcing of food ingredients, processing technologies, and application, this book: Explores new food ingredients as well as impact of processing on ingredient interactions Describes new techniques that improve the flavor and acceptability of functional food ingredients Reviews mathematical tools used for recipe formulation, process control and consumer studies Includes regulations and legislations around tailor-made food products Food Formulation: Novel Ingredients and Processing Techniques is an invaluable resource for students, educators, researchers, food technologists, and professionals, engineers and scientists across the food industry.