pharmaceutical experimental design

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Pharmaceutical Experimental Design

Author : Gareth A. Lewis
ISBN : 9780824746889
Genre : Mathematics
File Size : 32. 5 MB
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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 Experimental Design And Interpretation

Author : N. Anthony Armstrong
ISBN : 020348309X
Genre : Medical
File Size : 21. 82 MB
Format : PDF
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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.

Pharmaceutical And Medical Device Validation By Experimental Design

Author : Lynn D Torbeck
ISBN : 1420055704
Genre : Medical
File Size : 78. 76 MB
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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 approach to use, using realistic case studies, illustrations, and where appropriate, step-by-step protocols and procedures.

Research Methods For Pharmaceutical Practice And Policy

Author : Rajender R. Aparasu
ISBN : 9780853698807
Genre : Medical
File Size : 77. 45 MB
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This text provides the theory and practice for conducting pharmaceutical policy research. It covers all aspects of scientific research from conceptualising to statistical analysis. It also provides scientific basis and a good understanding of the principles and practice of conducting pharmaceutical policy research.--[Source inconnue].

Design And Manufacture Of Pharmaceutical Tablets

Author : Reynir Eyjolfsson
ISBN : 9780128021873
Genre : Medical
File Size : 28. 10 MB
Format : PDF
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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

Pharmaceutical Quality By Design

Author : Walkiria S. Schlindwein
ISBN : 9781118895214
Genre : Science
File Size : 24. 53 MB
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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.

Optimum Experimental Designs With Sas

Author : Anthony Atkinson
ISBN : 9780199296590
Genre : Business & Economics
File Size : 77. 87 MB
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Experiments in the field and in the laboratory cannot avoid random error and statistical methods are essential for their efficient design and analysis. Authored by leading experts in key fields, this text provides many examples of SAS code, results, plots and tables, along with a fully supported website.

Design And Analysis Of Animal Studies In Pharmaceutical Development

Author : Shein-Chung Chow
ISBN : 0824701305
Genre : Mathematics
File Size : 64. 49 MB
Format : PDF, Docs
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"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "

Research In The Biomedical Sciences

Author : Michael Williams
ISBN : 9780128047262
Genre : Science
File Size : 77. 18 MB
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Research in the Biomedical Sciences: Transparent and Reproducible documents the widespread concerns related to reproducibility in biomedical research and provides a best practices guide to effective and transparent hypothesis generation, experimental design, reagent standardization (including validation and authentication), statistical analysis, and data reporting. The book addresses issues in the perceived value of the existing peer review process and calls for the need for improved transparency in data reporting. It reflects new guidelines for publication that include manuscript checklists, replication/reproducibility initiatives, and the potential consequences for the biomedical research community and societal health and well-being if training, mentoring, and funding of new generations of researchers and incentives for publications are not improved. This book offers real world examples, insights, and solutions to provide a thought-provoking and timely resource for all those learning about, or engaged in, performing and supervising research across the biomedical sciences. Provides a “big picture perspective on the scope of reproducibility issues and covers initiatives that have potential as effective solutions Offers real-world research context for transparent, reproducible experimental design, execution and reporting of biomedical research with the potential to address aspects of the translational gap in drug discovery Highlights the importance of reproducibility and the necessary changes in biomedical and pharmaceutical research training and incentives to ensure sustainability

Guidebook On Molecular Modeling In Drug Design

Author : N. Claude Cohen
ISBN : 012178245X
Genre : Medical
File Size : 55. 77 MB
Format : PDF
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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).

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