Download or read book Computational and Experimental Design of Biopharmaceutical Formulations written by Vladimir I. Razinkov and published by Academic Press. This book was released on 2021-11-03 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book High Throughput Formulation Development of Biopharmaceuticals written by Vladimir I. Razinkov and published by Woodhead Publishing. This book was released on 2016-09-29 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Computational Pharmaceutics written by Defang Ouyang and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: Molecular modeling techniques have been widely used in drug discovery fields for rational drug design and compound screening. Now these techniques are used to model or mimic the behavior of molecules, and help us study formulation at the molecular level. Computational pharmaceutics enables us to understand the mechanism of drug delivery, and to develop new drug delivery systems. The book discusses the modeling of different drug delivery systems, including cyclodextrins, solid dispersions, polymorphism prediction, dendrimer-based delivery systems, surfactant-based micelle, polymeric drug delivery systems, liposome, protein/peptide formulations, non-viral gene delivery systems, drug-protein binding, silica nanoparticles, carbon nanotube-based drug delivery systems, diamond nanoparticles and layered double hydroxides (LDHs) drug delivery systems. Although there are a number of existing books about rational drug design with molecular modeling techniques, these techniques still look mysterious and daunting for pharmaceutical scientists. This book fills the gap between pharmaceutics and molecular modeling, and presents a systematic and overall introduction to computational pharmaceutics. It covers all introductory, advanced and specialist levels. It provides a totally different perspective to pharmaceutical scientists, and will greatly facilitate the development of pharmaceutics. It also helps computational chemists to look for the important questions in the drug delivery field. This book is included in the Advances in Pharmaceutical Technology book series.

Download or read book Pharmaceutical Experimental Design written by Gareth A. Lewis and published by CRC Press. This book was released on 1998-09-10 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development.Shows how to overcome pharmaceutical, technological, and economic constraint

Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Developability of Biotherapeutics written by Sandeep Kumar and published by CRC Press. This book was released on 2015-11-18 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Progress and challenges in computational structure based design and development of biologic drugs written by Traian Sulea and published by Frontiers Media SA. This book was released on 2024-03-25 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biopharmaceutics Modeling and Simulations written by Kiyohiko Sugano and published by John Wiley & Sons. This book was released on 2012-07-31 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction to using modeling and simulation programs in drug discovery and development Biopharmaceutical modeling has become integral to the design and development of new drugs. Influencing key aspects of the development process, including drug substance design, formulation design, and toxicological exposure assessment, biopharmaceutical modeling is now seen as the linchpin to a drug's future success. And while there are a number of commercially available software programs for drug modeling, there has not been a single resource guiding pharmaceutical professionals to the actual tools and practices needed to design and test safe drugs. A guide to the basics of modeling and simulation programs, Biopharmaceutics Modeling and Simulations offers pharmaceutical scientists the keys to understanding how they work and are applied in creating drugs with desired medicinal properties. Beginning with a focus on the oral absorption of drugs, the book discusses: The central dogma of oral drug absorption (the interplay of dissolution, solubility, and permeability of a drug), which forms the 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 for biopharmaceutical modeling Reliable practices for reporting results With over 200 figures and illustrations and a peerless examination of all the key aspects of drug research—including running and interpreting models, validation, and compound and formulation selection—this reference seamlessly brings together the proven practical approaches essential to developing the safe and effective medicines of tomorrow.

Download or read book Exploring Computational Pharmaceutics written by Defang Ouyang and published by John Wiley & Sons. This book was released on 2024-06-21 with total page 629 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides an extensive and up-to-date overview of the theory and application of computational pharmaceutics in the drug development process Exploring Computational Pharmaceutics - AI and Modeling in Pharma 4.0 introduces a variety of current and emerging computational techniques for pharmaceutical research. Bringing together experts from academia, industry, and regulatory agencies, this edited volume also explores the current state, key challenges, and future outlook of computational pharmaceutics while encouraging development across all sectors of the field. Throughout the text, the authors discuss a wide range of essential topics, from molecular modeling and process simulation to intelligent manufacturing and quantitative pharmacology. Building upon Exploring Computational Pharmaceutics - AI and Modeling in Pharma 4.0, this new edition provides a multi-scale perspective that reveals the physical, chemical, mathematical, and data-driven details of pre-formulation, formulation, process, and clinical studies, in addition to in vivo prediction in the human body and precision medicine in clinical settings. Detailed chapters address both conventional dosage forms and the application of computational technologies in advanced pharmaceutical research, such as dendrimer-based delivery systems, liposome and lipid membrane research, and inorganic nanoparticles. A major contribution to the development and promotion of computational pharmaceutics, this important resource: Discusses the development track, achievements, and prospects of computational pharmaceutics Presents multidisciplinary research to help physicists, chemists, mathematicians, and computer scientists locate problems in the field of drug delivery Covers a wide range of technologies, including complex formulations for water-insoluble drugs, protein/peptide formulations, nanomedicine, and gene delivery systems Focuses on the application of cutting-edge computational technologies and intelligent manufacturing of emerging pharmaceutical technologies Includes a systematic overview of computational pharmaceutics and Pharma 4.0 to assist non-specialist readers Covering introductory, advanced, and specialist topics, Exploring Computational Pharmaceutics - AI and Modeling in Pharma 4.0 is an invaluable resource for computational chemists, computational analysts, pharmaceutical chemists, process engineers, process managers, and pharmacologists, as well as computer scientists, medicinal chemists, clinical pharmacists, material scientists, and nanotechnology specialists working in the field.

Download or read book Biopharmaceutics written by Hannah Batchelor and published by John Wiley & Sons. This book was released on 2021-12-20 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures Comprehensive explorations of solubility, permeability, and dissolution Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.

Download or read book Computer Aided Pharmaceutics and Drug Delivery written by Vikas Anand Saharan and published by Springer Nature. This book was released on 2022-05-30 with total page 767 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the role of computer-assisted techniques for discovering, designing, optimizing and manufacturing new, effective, and safe pharmaceutical formulations and drug delivery systems. The book discusses computational approaches, statistical modeling and molecular modeling for the development and safe delivery of drugs in humans. The application of concepts of QbD (Quality by Design), DoE (Design of Experiments), artificial intelligence and in silico pharmacokinetic assessment/simulation have been made a lot easier with the help of commercial software and expert systems. This title provides in-depth knowledge of such useful software with illustrations from the latest researches. The book also fills in the gap between pharmaceutics and molecular modeling at micro, meso and maro scale by covering topics such as advancements in computer-aided Drug Design (CADD), drug-polymer interactions in drug delivery systems, molecular modeling of nanoparticles and pharmaceutics/bioinformatics. This book provides abundant applications of computers in formulation designing and characterization are provided as examples, case studies and illustrations. Short reviews of software, databases and expert systems have also been added to culminate the interest of readers for novel applications in formulation development and drug delivery. Computer-aided pharmaceutics and drug delivery is an authoritative reference source for all the latest scholarly update on emerging developments in computed assisted techniques for drug designing and development. The book is ideally designed for pharmacists, medical practitioners, students and researchers.

Download or read book Handbook of Preformulation written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-03-22 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity. Features: Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects Includes extensive flow charts for characterization decision making Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization Includes over 50% new material

Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 2434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Download or read book 24th European Symposium on Computer Aided Process Engineering written by and published by Elsevier. This book was released on 2014-06-20 with total page 1966 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Computer Aided Applications in Pharmaceutical Technology written by Jelena Duris and published by Elsevier. This book was released on 2023-09-18 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Computer-Aided Applications in Pharmaceutical Technology: Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations, Second Edition covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with an emphasis on their applications in process control, neural computing, data science, computer-aided biopharmaceutical characterization, as well as the application of computational fluid dynamics in pharmaceutical technology. Completely updated, the book introduces the theory and practice of computational tools through new case studies. Chapters cover Quality by Design in pharmaceutical development, overview data mining methodologies, present computer-aided formulation development, cover experimental design applications, and much more. Presents a comprehensive review of the current state of the art on various computer-aided applications in pharmaceutical technology Includes case studies to facilitate understanding of various concepts in computer-aided applications Covers applications such as the development of dosage forms and/or delivery systems, pharmaceutical unit operations, and relevant physiologically based pharmacokinetic simulations

Download or read book Development of Biopharmaceutical Drug Device Products written by Feroz Jameel and published by Springer Nature. This book was released on 2020-03-13 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Download or read book Freeze Drying of Pharmaceutical Products written by Davide Fissore and published by CRC Press. This book was released on 2019-10-24 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.