AHFS Drug Information 2008

First published in 1959, the "Big Red Book," as it's come to be known, has gone the extra mile for pharmacists and healthcare professionals seeking answers to the most detailed questions. It provides more extensive evidence-based data than any other drug reference. AHFS DI is the only reference free from the influence of manufacturers, insurers, regulators, and other special interests, giving you an unbiased source of drug information.

if messages about scripts error bother you try this:first define the drug you want, than click on + to open all subfolder which lie in the medicine name direction, than click on + near folder Document Body Date - and choose AFHS Drug InformationB(2008) - if you will work in such way you will recieve only one message about error.

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Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products

Hardbound. In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given.

Features of this book:

• Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry

• Illustrates the different approaches available to attain robustness

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Pharmacokinetics: Regulatory, Industrial, Academic Perspectives

Offering a unique, multidisciplinary approach, this state-of-the-art Second Edition details the rapidly changing role that clinical and non-clinical pharmacokinetics and drug metabolism play in the discovery and development of drug therapies -- emphasizing often overlooked regulatory, scientific, and economic issues.

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The Pharmaceutical Regulatory Process, Second Edition

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

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ISO 14001 Environmental Certification Step by Step: Revised Edition

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The do-it-yourself manual, with steps to success and simple explanatory notes, designed for real companies. ISO 14001 Environmental Certification Step by Step has been written with smaller companies especially in mind.

Dr. A.J. Edwards explains how to achieve the ISO 14001 standard aided by resources freely available from the accompanying website, including a sample manual and detailed sample registers and procedures. Together, these provide a quick and straightforward guide to achieving the requirements of ISO 14001 Environmental Certification.

This revised edition has been updated to cover the latest developments in the interpretation of the standard, plus changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), Control of Pollution regulations, Dangerous Substances and Explosive Atmospheres Regulations, Landfill charges, Pollution Prevention and Control, and Asbestos Regulations. In addition, the new ISO 19011:2002 standard for auditing is reflected in the book, as are approaches to phased introduction of ISO 14001.

Many organisations working towards ISO 14001 already possess ISO 9000 registration, or choose to achieve ISO 14001 and ISO 9000 simultaneously as an integrated system.To prevent duplication, ISO 14001 Environmental Certification Step by Step includes cross-referencing of ISO 14001 requirements to the relevant procedures in the Quality System.

* A do-it-yourself manual, with steps to success and simple explanatory notes

* Revised and updated to cover developments in the interpretation of the standard, changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), new standards and standards

* Supported by downloadable forms and procedures

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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general prose style that makes it useful to both students and professionals.

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