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Multivariate Analysis In The Pharmaceutical Industry

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Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry Book
Author : Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn
Publisher : Academic Press
Release : 2018-04-24
ISBN : 012811066X
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Axel Sell,Monica Mundkowski
Publisher : Unknown
Release : 1977
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Patent Protection and Economic Development book written by Axel Sell,Monica Mundkowski, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Using Multivariate Analysis for Pharmaceutical Drug Product Development

Using Multivariate Analysis for Pharmaceutical Drug Product Development Book
Author : Yifan Wang
Publisher : Unknown
Release : 2016
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Release : 2018-01-05
ISBN : 1118895215
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Release : 2019-04-09
ISBN : 1119285496
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Daemon Lincoln
Publisher : Unknown
Release : 1994
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : David J. am Ende
Publisher : John Wiley & Sons
Release : 2011-03-10
ISBN : 1118088107
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : C. Ralph Buncher,Jia-Yeong Tsay
Publisher : CRC Press
Release : 2019-03-07
ISBN : 142005645X
Language : En, Es, Fr & De

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Book Description :

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.

Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry Book
Author : Steven Ostrove
Publisher : Academic Press
Release : 2019-06-13
ISBN : 0128175699
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Francois Husson,Sebastien Le,Jérôme Pagès
Publisher : CRC Press
Release : 2010-11-15
ISBN : 1439835810
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
Release : 2017-10-09
ISBN : 0470942371
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Release : 2016-11-08
ISBN : 0128026375
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
Publisher : CRC Press
Release : 2011-12-07
ISBN : 1439829454
Language : En, Es, Fr & De

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Book Description :

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.

Computer Aided Multivariate Analysis Fourth Edition

Computer Aided Multivariate Analysis  Fourth Edition Book
Author : Abdelmonem Afifi,Susanne May,Virginia A. Clark
Publisher : CRC Press
Release : 2003-12-29
ISBN : 9781584883081
Language : En, Es, Fr & De

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Book Description :

Computer-Aided Multivariate Analysis, Fourth Edition enables researchers and students with limited mathematical backgrounds to understand the concepts underlying multivariate statistical analysis, perform analysis using statistical packages, and understand the output. New topics include Loess and Poisson regression, nominal and ordinal logistic regression, interpretation of interactions in logistic and survival analysis, and imputation for missing values. This book includes new exercises and references, and updated options in the latest versions of the statistical packages. All data sets and codebooks are available for download. The authors explain the assumptions made in performing each analysis and test, how to determine if your data meets those assumptions, and what to do if they do not. What to Watch out for sections in each chapter warn of common difficulties. By reading this text, you will know what method to use with your data set, how to get the results, and how to interpret them and explain them to others. New in the Fourth Edition: Expanded explanation of checking for goodness of fit in logistic regression and survival analysis Kaplan-Meier estimates of survival curves, formal tests for comparing survival between groups, interactions and the use of time-dependent covariates in survival analysis Expanded discussion of how to handle missing values Latest features of the S-PLUS package in addition to SAS, SPSS, STATA, and STATISTICA for multivariate analysis Data sets for the problems are available at the CRC web site: http://www.crcpress.com/product/isbn/9781584883081 Commands and output for examples used in the text for each statistical package are available at the UCLA web site: http://www.ats.ucla.edu/stat/examples/cama4/

Direct Analysis in Real Time Mass Spectrometry

Direct Analysis in Real Time Mass Spectrometry Book
Author : Yiyang Dong
Publisher : John Wiley & Sons
Release : 2017-11-27
ISBN : 3527803734
Language : En, Es, Fr & De

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Book Description :

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.

Mathematical Tools for Applied Multivariate Analysis

Mathematical Tools for Applied Multivariate Analysis Book
Author : Paul E. Green,J. Douglas Carroll
Publisher : Unknown
Release : 1976
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This book introduces matrix algebra to students in behavioral and administrative sciences. It clearly defines the relevance of the exercises to concerns within the business community and the social and behavioral sciences. Readers will gain a technical background for tackling applications-oriented multivariate texts.

Digital Twins

Digital Twins Book
Author : Christoph Herwig,Ralf Pörtner,Johannes Möller
Publisher : Springer Nature
Release : 2021-05-27
ISBN : 3030716600
Language : En, Es, Fr & De

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Book Description :

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.

Multivariate Interpretation of Clinical Laboratory Data

Multivariate Interpretation of Clinical Laboratory Data Book
Author : Adelin Albert
Publisher : CRC Press
Release : 1987-01-09
ISBN : 9780824777357
Language : En, Es, Fr & De

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Book Description :

This first of its kind guide describes statistical methods for the effective and efficient analysis of multivariate laboratory data, providing coverage which goes well beyond the standard single-sample diagnostic tools that regularly appear in medical literature.

Micro and Nanotechnologies Based Product Development

Micro  and Nanotechnologies Based Product Development Book
Author : Neelesh Kumar Mehra,Arvind Gulbake
Publisher : CRC Press
Release : 2021-09-06
ISBN : 1000421600
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Release : 2008-11-16
ISBN : 0387856277
Language : En, Es, Fr & De

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Book Description :

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.