Pharmaceutical Experimental Design Book

Pharmaceutical Experimental Design


  • Author : Gareth A. Lewis
  • Publisher : CRC Press
  • Release Date : 1998-09-10
  • Genre: Mathematics
  • Pages : 512
  • ISBN 10 : 9780824746889

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Pharmaceutical Experimental Design 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

Pharmaceutical Experimental Design And Interpretation Book
Score: 3
From 1 Ratings

Pharmaceutical Experimental Design And Interpretation


  • Author : N. Anthony Armstrong
  • Publisher : CRC Press
  • Release Date : 2002-09-11
  • Genre: Medical
  • Pages : 285
  • ISBN 10 : 020348309X

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Pharmaceutical Experimental Design And Interpretation Excerpt :

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.

Design of Experiments for Chemical  Pharmaceutical  Food  and Industrial Applications Book

Design of Experiments for Chemical Pharmaceutical Food and Industrial Applications


  • Author : Carrillo-Cedillo, Eugenia Gabriela
  • Publisher : IGI Global
  • Release Date : 2019-12-13
  • Genre: Science
  • Pages : 429
  • ISBN 10 : 9781799815204

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Design of Experiments for Chemical Pharmaceutical Food and Industrial Applications Excerpt :

Statistics is a key characteristic that assists a wide variety of professions including business, government, and factual sciences. Companies need data calculation to make informed decisions that help maintain their relevance. Design of experiments (DOE) is a set of active techniques that provides a more efficient approach for industries to test their processes and form effective conclusions. Experimental design can be implemented into multiple professions, and it is a necessity to promote applicable research on this up-and-coming method. Design of Experiments for Chemical, Pharmaceutical, Food, and Industrial Applications is a pivotal reference source that seeks to increase the use of design of experiments to optimize and improve analytical methods and productive processes in order to use less resources and time. While highlighting topics such as multivariate methods, factorial experiments, and pharmaceutical research, this publication is ideally designed for industrial designers, research scientists, chemical engineers, managers, academicians, and students seeking current research on advanced and multivariate statistics.

Pharmaceutical and Medical Device Validation by Experimental Design Book

Pharmaceutical and Medical Device Validation by Experimental Design


  • Author : Lynn D Torbeck
  • Publisher : CRC Press
  • Release Date : 2007-06-26
  • Genre: Medical
  • Pages : 272
  • ISBN 10 : 9781420055702

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Pharmaceutical and Medical Device Validation by Experimental Design Excerpt :

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational ap

Design of Experiments for Pharmaceutical Product Development Book

Design of Experiments for Pharmaceutical Product Development


  • Author : Sarwar Beg
  • Publisher : Springer Nature
  • Release Date : 2021-01-22
  • Genre: Medical
  • Pages : 188
  • ISBN 10 : 9789813343511

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Design of Experiments for Pharmaceutical Product Development Excerpt :

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

Pharmaceutical Experimental Design Book

Pharmaceutical Experimental Design


  • Author : Gareth A. Lewis
  • Publisher : CRC Press
  • Release Date : 1998-09-10
  • Genre: Mathematics
  • Pages : 512
  • ISBN 10 : 0824798600

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Pharmaceutical Experimental Design 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 constraints on experiment design!Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design· offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books· reviews screening designs for qualitative factors at different levels· presents designs for predictive models and their use in optimization· highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability· discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer· details nonstandard designs and mixtures· analyzes factorial, D-optimal design, and offline quality assurance techniques· reveals how one experimental design evolves from another· and more!Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.

Pharmaceutical Quality by Design Book

Pharmaceutical Quality by Design


  • Author : Walkiria S. Schlindwein
  • Publisher : John Wiley & Sons
  • Release Date : 2018-01-05
  • Genre: Science
  • Pages : 368
  • ISBN 10 : 9781118895214

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Pharmaceutical Quality by Design Excerpt :

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.

Understanding Experimental Design and Interpretation in Pharmaceutics Book

Understanding Experimental Design and Interpretation in Pharmaceutics


  • Author : N. Anthony Armstrong
  • Publisher : Ellis Horwood Limited
  • Release Date : 1990
  • Genre: Medical
  • Pages : 184
  • ISBN 10 : UOM:39015022010402

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Understanding Experimental Design and Interpretation in Pharmaceutics Excerpt :

Addresses experimental and optimization techniques in the context of pharmaceutical research, formulation and manufacture. Specific techniques are described, showing concepts, benefits and limitations. The book includes clinical and consumer trials from a spectrum of pharmaceutical sciences.

Chemical Engineering in the Pharmaceutical Industry Book

Chemical Engineering in the Pharmaceutical Industry


  • Author : Mary T. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-08
  • Genre: Technology & Engineering
  • Pages : 688
  • ISBN 10 : 9781119285502

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Chemical Engineering in the Pharmaceutical Industry Excerpt :

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 sc

Concepts and Experimental Protocols of Modelling and Informatics in Drug Design Book

Concepts and Experimental Protocols of Modelling and Informatics in Drug Design


  • Author : Om Silakari
  • Publisher : Academic Press
  • Release Date : 2020-11-05
  • Genre: Business & Economics
  • Pages : 396
  • ISBN 10 : 9780128205471

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Concepts and Experimental Protocols of Modelling and Informatics in Drug Design Excerpt :

Concepts and Experimental Protocols of Modelling and Informatics in Drug Design discusses each experimental protocol utilized in the field of bioinformatics, focusing especially on computer modeling for drug development. It helps the user in understanding the field of computer-aided molecular modeling (CAMM) by presenting solved exercises and examples. The book discusses topics such as fundamentals of molecular modeling, QSAR model generation, protein databases and how to use them to select and analyze protein structure, and pharmacophore modeling for drug targets. Additionally, it discusses data retrieval system, molecular surfaces, and freeware and online servers. The book is a valuable source for graduate students and researchers on bioinformatics, molecular modeling, biotechnology and several members of biomedical field who need to understand more about computer-aided molecular modeling. Presents exercises with solutions to aid readers in validating their own protocol Brings a thorough interpretation of results of each exercise to help readers compare them to their own study Explains each parameter utilized in the algorithms to help readers understand and manipulate various features of molecules and target protein to design their study

Pharmaceutical Quality by Design Book

Pharmaceutical Quality by Design


  • Author : Sarwar Beg
  • Publisher : Academic Press
  • Release Date : 2019-03-27
  • Genre: Business & Economics
  • Pages : 448
  • ISBN 10 : 9780128163726

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Pharmaceutical Quality by Design Excerpt :

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Strategies for Formulations Development Book

Strategies for Formulations Development


  • Author : Ronald Snee
  • Publisher : SAS Institute
  • Release Date : 2016-09-27
  • Genre: Computers
  • Pages : 294
  • ISBN 10 : 9781629605302

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Strategies for Formulations Development Excerpt :

Strategies for Formulations Development: A Step-by-Step Guide Using JMP is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process. With this book you will be able to: Approach the development process from a strategic viewpoint with the overall end result in mind. Design screening experiments to identify components that are most important to the performance of the formulation. Design optimization experiments to identify the maximum response in the design space. Analyze both screening and optimization experiments using graphical and numerical methods. Optimize multiple criteria, such as the quality, cost, and performance of product formulations. Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%. Linking dynamic graphics with powerful statistics, JMP helps construct a visually compelling narrative to interactively share findings that are coherent and actionable by colleagues and decision makers. Using this book, you can take advantage of computer generated experiment designs when classical designs do not suffice, given the physical and economic constraints of the experiential environment. Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is unique because it provides formulation scientists with the essential information they need in order to successfully conduct formulation studies in the chemical, biotech, and pharmaceutical industries.

Bayesian Methods in Pharmaceutical Research Book

Bayesian Methods in Pharmaceutical Research


  • Author : Emmanuel Lesaffre
  • Publisher : CRC Press
  • Release Date : 2020-04-28
  • Genre: Medical
  • Pages : 516
  • ISBN 10 : 9781351718660

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Bayesian Methods in Pharmaceutical Research Excerpt :

Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research. Emmanuel Lesaffre is Professor of Biostatistics at KU Leuven, Belgium. Gianluca Baio is Professor of Statistics and Health Economics at University College London, UK. Bruno Boulanger is Chief Scientific Officer at PharmaLex, Belgium.

Design and Manufacture of Pharmaceutical Tablets Book

Design and Manufacture of Pharmaceutical Tablets


  • Author : Reynir Eyjolfsson
  • Publisher : Academic Press
  • Release Date : 2014-10-15
  • Genre: Medical
  • Pages : 68
  • ISBN 10 : 9780128021873

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Design and Manufacture of Pharmaceutical Tablets Excerpt :

Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book. Incorporates important mathematical models and computational applications Includes unique content on central composite design and augmented simplex lattice Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms

Guidebook on Molecular Modeling in Drug Design Book
Score: 4
From 1 Ratings

Guidebook on Molecular Modeling in Drug Design


  • Author : N. Claude Cohen
  • Publisher : Gulf Professional Publishing
  • Release Date : 1996-05-10
  • Genre: Medical
  • Pages : 361
  • ISBN 10 : 012178245X

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Guidebook on Molecular Modeling in Drug Design Excerpt :

The molecular modeling perspective in drug design. (N. Calude Cohen). Molecular graphics and modeling: tools of the trade. (Roderick E. Hubbard). Molecular modeling of small molecules. (Tamara Gund). Computer assisted new lead design. (Akiko Itai, Miho Yamada Mizutani, Yoshihiko Nishibata, and Nubuo Tomioka). Experimental techniques and data banks. (John P. Priestle and C. Gregory Paris). Computer-assisted drug discovery. (Peter Gund, Gerald Maggiora, and James P. Snyder). Modeling drug-receptor interactions. (Konrad F. Koehler, Shashidhar N. Rao, and James P. Snyder). Glossary of terminology. (J. P. Tollenaere).