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Pharmaceutical and Medical Device Validation by Experimental Design
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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.
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Posted in books by kdsaggi on Aug. 22, 2008 // 07:29
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Future of Glycerol: New Usages for a Versatile Raw Material
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This book aims to inform chemistry professionals, including managers and technologists, on the large potential of glycerol as versatile biofeedstock for the production of a variety of chemicals, polymers and fuels. Whilst filling a gap in the current literature, this nicely illustrated book is written in a clear, concise style and presents the numerous uses of glycerol as a new raw material which are starting to have an impact on industry worldwide. Elucidation of the principles governing the new chemistry of glycerol goes along with updated industrial information that is generally difficult to retrieve. Through its 10 chapters, the monograph tells the story of a chemical success that of converting glycerol into value added
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Posted in books by kdsaggi on Aug. 22, 2008 // 07:30
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Understanding Drug Release and Absorption Mechanisms: A Physical and Mathematical Approach
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Demand for better reliability from drug delivery systems has caused designers and researchers to move away from trial-and-error approaches and toward model-based methods of product development. Developing such models requires cross-disciplinary physical, mathematical, and physiological knowledge. Combining these areas under a single cover, Understanding Drug Release and Absorption Mechanisms builds a firm understanding ofall elements needed to conceive, build, and implement successful models of drug release. Written by experts with broad industrial and academic experience, this book discusses the underlying physical principles, shows how to build mathematical models based on these principles, and finally compares the resulting models with experimental results. The authors begin by introducing the basics of modeling, physiological details of gastrointestinal and dermal absorption pathways, rheology, mass transport and thermodynamics, dissolution and partitioning, as well as size effects on the dissolution of crystallites. From this baseline, the authors explore applications in drug release from various delivery systems, specifically matrix systems, microemulsions, and permeability through membranes.
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Posted in books by kdsaggi on Aug. 22, 2008 // 07:31
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A Manager's Guide to the Design and Conduct of Clinical Trials
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This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.
Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.
This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-includethe following material:
* Should the trials be conducted?
* Put it in the computer and keep it there
* Staffing for success
* Designing trials and determining sample size
* Budgeting
* Recruiting and retaining patients and physicians
* Data management
* Monitoring the trials
* Data analysis
* After action review
* Exception handling
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Posted in books by kdsaggi on Aug. 22, 2008 // 07:33
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Clinical Studies Management - A Practical Guide to Success
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A comprehensive desk reference, this
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Posted in books by kdsaggi on Aug. 22, 2008 // 07:33
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