Download Multivariate Analysis in the Pharmaceutical Industry Ebook PDF

Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry
A Book

by Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn

  • Publisher : Academic Press
  • Release : 2018-04-24
  • Pages : 464
  • ISBN : 012811066X
  • Language : En, Es, Fr & De
GET BOOK

Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Patent Protection and Economic Development

Patent Protection and Economic Development
A Multivariate Analysis in the Pharmaceutical Industry in Latin America

by Axel Sell,Monica Mundkowski

  • Publisher : Unknown Publisher
  • Release : 1977
  • Pages : 50
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
GET BOOK

Patent protection and economic development

Patent protection and economic development
a multivariate analysis in the pharmaceutical industry in Latin America

by Axel Sell,Monika Mundkowski-Bek

  • Publisher : Unknown Publisher
  • Release : 1977
  • Pages : 50
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
GET BOOK

Using Multivariate Analysis for Pharmaceutical Drug Product Development

Using Multivariate Analysis for Pharmaceutical Drug Product Development
A Book

by Yifan Wang

  • Publisher : Unknown Publisher
  • Release : 2016
  • Pages : 208
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
GET BOOK

Manufacturing of pharmaceutical products has a prominent role in the healthcare industry. Generally, the ultimate aim of pharmaceutical development is to release to the market products with acceptable quality. As advanced pharmaceutical manufacturing technologies such as continuous tablet manufacturing, are developed and embraced, it is essential to adopt a scientific, risk-based, and proactive approach for pharmaceutical development. The work presented in this dissertation focuses on using multivariate analysis tools to establish a predictive capability for pharmaceutical process and product development, especially when the amount of materials available is limited. Importantly, the methodologies developed in this dissertation can be applied easily to powder handling and processing in a wider range of industries, such as cosmetic, catalyst, chemical, petrochemical, and food. In this work, methods for analyzing flow properties of raw materials and predict process performance were developed. A method to analyze shear cell data of powders measured under different initial consolidation stresses was introduced. The method was shown to reduce significantly the complexity of shear cell data, and to enabled comparison of materials measured under different initial consolidation stresses. In addition, a predictive correlation between material flow properties and feeder performance was developed. By using multivariate models, the feeding performance of a material with given flow properties can be predicted and quantified. Using a quality-by-design approach, the cohesion of a powder mixture can be predicted based on the concentration of each ingredient. The prediction model was further supplemented by a study investigating two mixing systems. Using statistical analysis, the effect of lubrication on blend flow properties was discussed. By quantifying the correlations between different flow property measurements, mixing systems that have different mixing mechanism were compared. Disadvantages of widely used dissolution comparison methods were addressed. Statistically reliable methodologies to analyze, compare, and predict drug in vitro release profiles were proposed. The proposed methods were shown to be able to consider the self-correlated intrinsic nature of dissolution profiles, and to use within-group variability to estimate the reliability of observations. Additionally, the work presented a case study to improve real-time release testing for advanced tablet manufacturing processes by achieving predictive capability for nondestructive dissolution testing. Using hierarchical multivariate analysis, the validated prediction models were able to predict dissolution profile of an individual tablet based on its NIR spectrum.

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
A Practical Approach

by Walkiria S. Schlindwein,Mark Gibson

  • Publisher : John Wiley & Sons
  • Release : 2018-01-11
  • Pages : 368
  • ISBN : 1118895223
  • Language : En, Es, Fr & De
GET BOOK

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
Drug Product Design, Development, and Modeling

by Mary T. am Ende,David J. am Ende

  • Publisher : John Wiley & Sons
  • Release : 2019-04-09
  • Pages : 688
  • ISBN : 1119285496
  • Language : En, Es, Fr & De
GET BOOK

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Chemometric Approaches to Method Validation in Liquid Chromatography for Pharmaceutical Analysis

Chemometric Approaches to Method Validation in Liquid Chromatography for Pharmaceutical Analysis
Univariate and Multivariate Analysis.....for Validation of Analytical Method Selectivity in Pharmaceutical Development

by Daemon Lincoln

  • Publisher : Unknown Publisher
  • Release : 1994
  • Pages : 213
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
GET BOOK

The successful hyphenation of chromatographic and spectroscopic methods in recent years has led to highly flexible separation systems, offering levels of selectivity and sensitivity previously unattainable. In addition to this, computer-aided hyphenated systems, typically LC-DAD and LC-MS, are making a major impact in the pharmaceutical industry, leading to novel techniques for on-line and off-line analytical method validation. In particular, a wide variety of both univariate and multivariate data processing methods have been developed for the critical area of peak homogeneity assessment in liquid chromatography. Theoretical considerations presented here would seem to indicate that significant gains in detection sensitivity for minor co-eluting impurities should be possible by employing LC-MS, as opposed to LC-DAD. This work also assesses the performance of several established multivariate statistical techniques for peak purity analysis against that of a newly developed approach, the K-Function. This is achieved by utilising real data sets from a reversed-phase LC-MS system for two solutes with identical UV-absorption spectra, and for a standard LC-DAD system with two solutes whose UV-absorption spectra are very similar (tilda 0.99). Simulated data sets are generated that allow the influence of chromatographic resolution, the minor component level, spectral correlation and signal-to-noise ratio to be Systematically investigated. Furthermore, the relevance of the differential information content of thermospray, particle beam-chemical ionisation and particle beam-electron impact mass spectra is considered with respect to the performance of multivariate techniques for peak purity assessment.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
R&D to Manufacturing

by David J. am Ende

  • Publisher : John Wiley & Sons
  • Release : 2011-03-10
  • Pages : 904
  • ISBN : 1118088107
  • Language : En, Es, Fr & De
GET BOOK

This book deals with various unique elements in the drugdevelopment process within chemical engineering science andpharmaceutical R&D. The book is intended to be used as aprofessional reference and potentially as a text book reference inpharmaceutical engineering and pharmaceutical sciences. Many of theexperimental methods related to pharmaceutical process developmentare learned on the job. This book is intended to provide many ofthose important concepts that R&D Engineers and manufacturingEngineers should know and be familiar if they are going to besuccessful in the Pharmaceutical Industry. These include basicanalytics for quantitation of reaction components– oftenskipped in ChE Reaction Engineering and kinetics books. In additionChemical Engineering in the Pharmaceutical Industryintroduces contemporary methods of data analysis for kineticmodeling and extends these concepts into Quality by Designstrategies for regulatory filings. For the current professionals,in-silico process modeling tools that streamlineexperimental screening approaches is also new and presented here.Continuous flow processing, although mainstream for ChE, is uniquein this context given the range of scales and the complex economicsassociated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts.These parts will address the fundamentals of analytical techniquesfor engineers, thermodynamic modeling, and finally provides anappendix with common engineering tools and examples of theirapplications.

Statistics In the Pharmaceutical Industry

Statistics In the Pharmaceutical Industry
A Book

by C. Ralph Buncher,Jia-Yeong Tsay

  • Publisher : CRC Press
  • Release : 2019-03-07
  • Pages : 504
  • ISBN : 142005645X
  • Language : En, Es, Fr & De
GET BOOK

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Exploration of Parameters for the Continuous Blending of Pharmaceutical Powders

Exploration of Parameters for the Continuous Blending of Pharmaceutical Powders
A Book

by Ben Chien Pang Lin,Massachusetts Institute of Technology. Department of Chemical Engineering

  • Publisher : Unknown Publisher
  • Release : 2011
  • Pages : 119
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
GET BOOK

The transition from traditional batch blending to continuous blending is an opportunity for the pharmaceutical industry to reduce costs and improve quality control. This operational shift necessitates a deeper understanding of the mixing process informed by particle dynamics and variable interdependencies. The thesis aims to establish a framework for characterizing and improving continuous pharmaceutical blending using a tiered experimental methodology and multivariate analysis. This parameter space exploration attempts to reconcile previous research within the context of cohesive pharmaceutical powders and develop general design principles for maximizing blender performance. A design of experiments was conducted to determine mixing performance with respect to three factors - physical design, operating parameters, and material properties. Multivariate analysis using projections to latent structures was employed to quantify the effect of raw and intermediate variables on the variance reduction ratio. Significant parameters identified included the choice of API, fill fraction, the number of blade passes, the mean residence time, the Bodenstein number, and the period of input feed fluctuations. The results highlight the importance of shear and radial mixing for cohesive powders, which suggest that one-dimensional axial models common in blending literature may not be a sufficient theoretical framework for pharmaceutical applications. The research yielded several insights into design principles for optimizing blending performance. Increasing mean residence time and radial mixing create more robust processing by reducing the impact of material properties and fluctuations in feed consistency. The variance reduction ratio can be improved in a cost-effective manner by determining the fill fraction which maximizes intermediate metrics such as space time, mean residence time, and the number of blade passes. Multivariate analysis was demonstrated to be a practical tool for parameter space optimization and a promising technique for characterizing the effect of material properties on processing.

Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry
A Book

by Steven Ostrove

  • Publisher : Academic Press
  • Release : 2019-06-13
  • Pages : 234
  • ISBN : 0128175699
  • Language : En, Es, Fr & De
GET BOOK

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Exploratory Multivariate Analysis by Example Using R

Exploratory Multivariate Analysis by Example Using R
A Book

by Francois Husson,Sebastien Le,Jérôme Pagès

  • Publisher : CRC Press
  • Release : 2010-11-15
  • Pages : 240
  • ISBN : 1439835810
  • Language : En, Es, Fr & De
GET BOOK

Full of real-world case studies and practical advice, Exploratory Multivariate Analysis by Example Using R focuses on four fundamental methods of multivariate exploratory data analysis that are most suitable for applications. It covers principal component analysis (PCA) when variables are quantitative, correspondence analysis (CA) and multiple correspondence analysis (MCA) when variables are categorical, and hierarchical cluster analysis. The authors take a geometric point of view that provides a unified vision for exploring multivariate data tables. Within this framework, they present the principles, indicators, and ways of representing and visualizing objects that are common to the exploratory methods. The authors show how to use categorical variables in a PCA context in which variables are quantitative, how to handle more than two categorical variables in a CA context in which there are originally two variables, and how to add quantitative variables in an MCA context in which variables are categorical. They also illustrate the methods and the ways they can be exploited using examples from various fields. Throughout the text, each result correlates with an R command accessible in the FactoMineR package developed by the authors. All of the data sets and code are available at http://factominer.free.fr/book By using the theory, examples, and software presented in this book, readers will be fully equipped to tackle real-life multivariate data.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
A Book

by Gintaras V. Reklaitis

  • Publisher : John Wiley & Sons
  • Release : 2017-10-09
  • Pages : 416
  • ISBN : 0470942371
  • Language : En, Es, Fr & De
GET BOOK

This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice

by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri

  • Publisher : Academic Press
  • Release : 2016-11-08
  • Pages : 1176
  • ISBN : 0128026375
  • Language : En, Es, Fr & De
GET BOOK

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

PAT Applied in Biopharmaceutical Process Development And Manufacturing

PAT Applied in Biopharmaceutical Process Development And Manufacturing
An Enabling Tool for Quality-by-Design

by Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch

  • Publisher : CRC Press
  • Release : 2011-12-07
  • Pages : 327
  • ISBN : 1439829454
  • Language : En, Es, Fr & De
GET BOOK

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.

Basics of Matrix Algebra for Statistics with R

Basics of Matrix Algebra for Statistics with R
A Book

by Nick Fieller

  • Publisher : CRC Press
  • Release : 2018-09-03
  • Pages : 248
  • ISBN : 1315360055
  • Language : En, Es, Fr & De
GET BOOK

A Thorough Guide to Elementary Matrix Algebra and Implementation in R Basics of Matrix Algebra for Statistics with R provides a guide to elementary matrix algebra sufficient for undertaking specialized courses, such as multivariate data analysis and linear models. It also covers advanced topics, such as generalized inverses of singular and rectangular matrices and manipulation of partitioned matrices, for those who want to delve deeper into the subject. The book introduces the definition of a matrix and the basic rules of addition, subtraction, multiplication, and inversion. Later topics include determinants, calculation of eigenvectors and eigenvalues, and differentiation of linear and quadratic forms with respect to vectors. The text explores how these concepts arise in statistical techniques, including principal component analysis, canonical correlation analysis, and linear modeling. In addition to the algebraic manipulation of matrices, the book presents numerical examples that illustrate how to perform calculations by hand and using R. Many theoretical and numerical exercises of varying levels of difficulty aid readers in assessing their knowledge of the material. Outline solutions at the back of the book enable readers to verify the techniques required and obtain numerical answers. Avoiding vector spaces and other advanced mathematics, this book shows how to manipulate matrices and perform numerical calculations in R. It prepares readers for higher-level and specialized studies in statistics.

Direct Analysis in Real Time Mass Spectrometry

Direct Analysis in Real Time Mass Spectrometry
Principles and Practices of DART-MS

by Yiyang Dong

  • Publisher : John Wiley & Sons
  • Release : 2017-11-27
  • Pages : 360
  • ISBN : 3527803734
  • Language : En, Es, Fr & De
GET BOOK

Clear, comprehensive, and state of the art, the groundbreaking book on the emerging technology of direct analysis in real time mass spectrometry Written by a noted expert in the field, Direct Analysis in Real Time Mass Spectrometry offers a review of the background and the most recent developments in DART-MS. Invented in 2005, DART-MS offers a wide range of applications for solving numerous analytical problems in various environments, including food science, forensics, and clinical analysis. The text presents an introduction to the history of the technology and includes information on the theoretical background, for exampleon the ionization mechanism. Chapters on sampling and coupling to different types of mass spectrometers are followed by a comprehensive discussion of a broad range of applications. Unlike most other ionization methods, DART does not require laborious sample preparation, as ionization takes place directly on the sample surface. This makes the technique especially attractive for applications in forensics and food science. Comprehensive in scope, this vital text: -Sets the standard on an important and emerging ionization technique -Thoroughly discusses all the relevant aspects from instrumentation to applications -Helps in solving numerous analytical problems in various applications, for example food science, forensics, environmental and clinical analysis -Covers mechanisms, coupling to mass spectrometers, and includes information on challenges and disadvantages of the technique Academics, analytical chemists, pharmaceutical chemists, clinical chemists, forensic scientists, and others will find this illuminating text a must-have resource for understanding the most recent developments in the field.

Digital Twins

Digital Twins
Tools and Concepts for Smart Biomanufacturing

by Christoph Herwig,Ralf Pörtner,Johannes Möller

  • Publisher : Springer Nature
  • Release : 2021-05-27
  • Pages : 262
  • ISBN : 3030716600
  • Language : En, Es, Fr & De
GET BOOK

This is the first of two volumes that together provide an overview of the latest advances in the generation and application of digital twins in bioprocess design and optimization. Both processes have undergone significant changes over the past few decades, moving from data-driven approaches into the 21st-century digitalization of the bioprocess industry. Moreover, the high demand for biotechnological products calls for efficient methods during research and development, as well as during tech transfer and routine manufacturing. In this regard, one promising tool is the use of digital twins, which offer a virtual representation of the bioprocess. They reflect the mechanistics of the biological system and the interactions between process parameters, key performance indicators and product quality attributes in the form of a mathematical process model. Furthermore, digital twins allow us to use computer-aided methods to gain an improved process understanding, to test and plan novel bioprocesses, and to efficiently monitor them. This book explains the mathematical structure of digital twins, their development and the model’s respective parts, as well as concepts for the knowledge-driven generation and structural variability of digital twins. Covering fundamentals as well as applications, the two volumes offer the ideal introduction to the topic for researchers in academy and industry alike.

Micro- and Nanotechnologies-Based Product Development

Micro- and Nanotechnologies-Based Product Development
A Book

by Neelesh Kumar Mehra,Arvind Gulbake

  • Publisher : CRC Press
  • Release : 2021-09-06
  • Pages : 326
  • ISBN : 1000421600
  • Language : En, Es, Fr & De
GET BOOK

This book provides comprehensive information of the nanotechnology-based pharmaceutical product development including a diverse range of arenas such as liposomes, nanoparticles, fullerenes, hydrogels, thermally responsive externally activated theranostics (TREAT), hydrogels, microspheres, micro- and nanoemulsions and carbon nanomaterials. It covers the micro- and nanotechnological aspects for pharmaceutical product development with the product development point of view and also covers the industrial aspects, novel technologies, stability studies, validation, safety and toxicity profiles, regulatory perspectives, scale-up technologies and fundamental concept in the development of products. Salient Features: Covers micro- and nanotechnology approaches with current trends with safety and efficacy in product development. Presents an overview of the recent progress of stability testing, reverse engineering, validation and regulatory perspectives as per regulatory requirements. Provides a comprehensive overview of the latest research related to micro- and nanotechnologies including designing, optimisation, validation and scale-up of micro- and nanotechnologies. Is edited by two well-known researchers by contribution of vivid chapters from renowned scientists across the globe in the field of pharmaceutical sciences. Dr. Neelesh Kumar Mehra is working as an Assistant Professor of Pharmaceutics & Biopharmaceutics at the Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He received ‘TEAM AWARD’ for successful commercialisation of an ophthalmic suspension product. He has authored more than 60 peer-reviewed publications in highly reputed international journals and more than 10 book chapter contributions. He has filed patents on manufacturing process and composition to improved therapeutic efficacy for topical delivery. He guided PhD and MS students for their dissertations/research projects. He has received numerous outstanding awards including Young Scientist Award and Team Award for his research output. He recently published one edited book, ‘Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives’, in CRC Press. Currently, he is editing books on nano drug delivery-based products with Elsevier Pvt Ltd. He has rich research and teaching experience in the formulation and development of complex, innovative ophthalmic and injectable biopharmaceutical products including micro- and nanotechnologies for regulated market. Dr. Arvind Gulbake is working as an Assistant Professor at the Faculty of Pharmacy, School of Pharmaceutical & Population Health Informatics, at DIT University, Dehradun, India. He has authored more than 40 peer-reviewed publications in highly reputed international journals, four book chapters and a patent contribution. He has received outstanding awards including Young Scientist Award and BRG Travel Award for his research. He is an assistant editor for IJAP. He guided PhD and MS students for their dissertations/research projects. He has successfully completed extramural project funded by SERB, New Delhi, Government of India. He has more than 12 years of research and teaching experience in the formulation and development of nanopharmaceuticals.

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
Regulations, Methodologies, and Best Practices

by Kim Huynh-Ba

  • Publisher : Springer Science & Business Media
  • Release : 2008-11-16
  • Pages : 389
  • ISBN : 0387856277
  • Language : En, Es, Fr & De
GET BOOK

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.