Sample Sizes for Clinical Trials

With worked examples and problems based on real-world scenarios, this book takes readers through the process of calculating the sample size for many types of clinical trials. It covers the most common types of clinical trials across all phases. The author discusses how assumptions made in a sample size calculation can impact the calculation. He provides calculations for many of the trials and offers hints and tips on how to optimize the calculations. He also illustrates the steps involved in determining sample size, from defining the trial objective to selecting an appropriate endpoint.

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Guide to Nutritional Supplements

The rapidly expanding world of nutrition, functional foods and nutraceuticals, is increasingly complex. This Guide to Nutritional Supplements provides a concise and complete reference to the most common nutritionally significant elements. Including dietary guidelines, intake measurements and other contextual information, this Guide is the ideal reference for nutritionists and dieticians facing an increasing public awareness of supplements and who many be augmenting their diets with OTC supplements.

Focused on the nutritional values, impacts and interactions of supplements

Provides a science-based approach to determining the appropriate selection and application of supplements for improved diet and nutrition.

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Preclinical Drug Development, Second Edition

Preclinical Drug Development, Second Edition discusses the broad realm of preclinical drug development, ranging from assessment of pharmacology and toxicology to the industry trends and regulatory expectations and requirements that support clinical trials. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.

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Handbook of Filter Media, Second Edition

This comprehensive handbook provides a complete and updated overview of filter media. From classification to performance date to practical selection tables.

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HVAC Systems Testing, Adjusting & Balancing

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Hvac Systems Duct Design 3rd Ed.

A fundamental duct system design manual for commercial and light industrial heating, ventilating and air conditioning systems. System effects for inlets and outlets of fans, noise control in ducts and use of extractors, splinters and dampers are included. New loss coefficients for elbows with 45-degree throats on square and radius heels and radius throats with square heels. Losses compare favorably with elbows with double wall turning vanes in several cases. Structured to offer the designer options in energy-efficient design methods, materials and construction. Includes soft metrics.

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Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set)

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

• cGMP compliance
• pre-approval inspections
• stability and bioequivalence testing
• packaging commodity development
• common difficulties in formulating drugs
• changes to aNDAs

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