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Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.


Tomatoes and Tomato Products: Nutritional, Medicinal and Therapeutic Properties

The contributors to this book are authors of international and national standing, leaders in the field and trendsetters. The book covers emerging fields of science and important discoveries relating to tomatoes and related products. This represents a one-stop shopping of material related to tomatoes. This book will be essential reading for plant scientists, nutritionists, dieticians, pharmacologists, health care professionals and research scientists.


Remington: The Science And Practice Of Pharmacy 21th Ed.

For over 100 years, Remington has been the definitive textbook and reference on the science and practice of pharmacy. This Twenty-First Edition keeps pace with recent changes in the pharmacy curriculum and professional pharmacy practice.

More than 95 new contributors and 5 new section editors provide fresh perspectives on the field. New chapters include pharmacogenomics, application of ethical principles to practice dilemmas, technology and automation, professional communication, medication errors, re-engineering pharmacy practice, management of special risk medicines, specialization in pharmacy practice, disease state management, emergency patient care, and wound care.


The Drugs and Cosmetics Act of India

An Act to regulate the import, manufacture, distribution and sale of drugs 2[and cosmetics]; WHEREAS it is expedient to regulate the 3[import, manufacture, distribution and sale] of drugs 2[and cosmetics];

AND WHEREAS the Legislature of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935 (26 Geo. 5, c.2), in relation to such of the above-mentioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act.


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.


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.


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.


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.

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.


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

Drug Delivery Nanoparticles Formulation and Characterization

Explore the fundamental concepts of drug delivery formulation and characterization.

Nanoparticulate Drug Delivery Systems II presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval.

This comprehensive guide features:

100 high quality images Process Analytical Techniques (PAT) used in manufacturing Nanoparticulate Drug Delivery Systems (NDDS) in-vitro and in-vivo evaluation of NDDS applications of novel techniques used in formulation development and characterization, such as microscopic and nonmicroscopic techniques.


Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, Second Edition

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry.

Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses:

candidate drug selection drug discovery and development preformulation predictions and drug selections product design to commercial dosage form biopharmaceutical support in formulation development and more.