Computational and Experimental Design of Biopharmaceutical Formulations PDF Download

Author: Vladimir I. Razinkov
Publisher: Academic Press
ISBN: 0128173491
Category : Medical
Languages : en
Pages : 230

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Book Description
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

Author: Vladimir I. Razinkov
Publisher: Woodhead Publishing
ISBN: 190881876X
Category : Medical
Languages : en
Pages : 133

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Book Description
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

Author: Defang Ouyang
Publisher: John Wiley & Sons
ISBN: 1118573994
Category : Science
Languages : en
Pages : 350

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Book Description
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.

Author: Feroz Jameel
Publisher: Springer
ISBN: 1493923161
Category : Medical
Languages : en
Pages : 710

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Book Description
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.

Author: N. Anthony Armstrong
Publisher: CRC Press
ISBN: 9780203483091
Category : Medical
Languages : en
Pages : 294

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Book Description
This work provides a description of the principles of experimental design and their application to pharmaceutical research. It includes worked examples taken from a wide variety of pharmaceutical techniques and processes.

Author: Gareth A. Lewis
Publisher: CRC Press
ISBN: 0203508688
Category : Mathematics
Languages : en
Pages : 515

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Book Description
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

Author: Sandeep Kumar
Publisher: CRC Press
ISBN: 1482246155
Category : Medical
Languages : en
Pages : 312

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Book Description
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

Author: Loan Huynh
Publisher:
ISBN:
Category :
Languages : en
Pages :

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Author: NATO Advanced Study Institute
Publisher:
ISBN:
Category :
Languages : en
Pages : 424

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Book Description

Author: Jelena Duris
Publisher: Elsevier
ISBN: 1908818328
Category : Computers
Languages : en
Pages : 300

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Book Description
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