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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

SODEOPEC (Soaps, Detergents, and Oleochemicals)

This book contains updated material from some of the salient presentations at the Soaps, Detergents, and Oleochemicals (1997) and SODEOPEC (2002) conferences, including several new chapters. Like its two predecessors, Soap Technology for the 1990's and Soaps and Detergents: A Theoretical and Practical Review, this publication will be a valuable resource for those who are active in the increasingly interrelated and quickly changing fields of soaps, detergents, oleochemicals, and personal care products.

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.

Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.

This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.

It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.

- Provides valuable information on isolation and characterization of impurities.
- Gives a regulatory perspective on the subject.
- Describes various considerations involved in meeting regulatory requirements.
- Discusses various sources of impurities and degredation products.


Pharmaceutical Biotechnology

Conceiving an up-to-date pharmaceutical biotechnology textbook that trains next-generation pharmacy students, as well as updating pharmacists and pharmaceutical scientists … is a formidable challenge, and one which the editors … have accomplished to a high standard … . … [Many chapters] contain industrial case-studies of blockbuster drugs, thus giving this textbook an industrial scope that is difficult to find elsewhere. All the chapters are easy to read and well illustrated to aid understanding of the interdisciplinary content. Each chapter is authored by experts in the field and contains a good introductory section and an in-depth discussion of each topic.

The field of pharmaceutical biotechnology is a rapidly evolving subject. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for a spectrum of serious diseases such as cancer, viral infections, cardiovascular and hereditary disorders. In addition, we are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy.

Completely revised and updated, this introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use.


Encyclopedia of Pharmaceutical Technology, Volume 20

AAI, Inc., Wilmington, NC. An encyclopedia of pharmaceutical technology, offering a collection of entries on a number of subjects, from drug delivery to process chemistry in the pharmaceutical industry. Lists the contents for all 20 volumes in the set. DNLM: Chemistry, Pharmaceutical-encyclopedias.

Smith and Williams' Introduction to the Principles of Drug Design and Action, Fourth Edition

As knowledge of biological systems has expanded and the number of techniques available for exploring and visualizing their components has increased, it has become possible to design drugs specifically for a given target. This unique insight has revolutionized the process of drug development for specific disease states. Smith and Williams' Introduction to the Principles of Drug Design and Action, 4th Edition provides a thorough introduction to the principles of rational drug design, including both novel and established approaches. The fourth edition of this popular textbook adopts a 'from the bench to the marketplace' approach, using real examples where possible. In addition to a comprehensive update of the previous edition, new advances in molecular techniques, biotechnological applications and computer-aided design have been added.

Electrically Assisted Transdermal and Topical Drug Delivery

This volume provides coverage assisted transdermal and topical delivery by mechanisms of iontophoresis, electroosmosis and electroporation. Other topics discussed are human and clinical studies with iontophoresis, such As Delivery Of Peptides, Proteins And Oligonucleotides, And Other developments.

HVAC Licensing Study Guide

Get All the Practice Questions and Answers, Calculations, and Troubleshooting Tips You Need to Ace the major HVAC Licensing Exams!

HVAC technicians and students alike can turn to the HVAC Licensing Study Guide for everything they need to prepare for and pass the major HVAC licensing exams on the very first try! Designed to boost confidence, skills, and knowledge, this unique career-building resource contains over 800 practice questions and answers, essential calculations, and step-by-step troubleshooting tips for the job site.

Written by two of the most experienced and successful authors in the HVAC field, this on-target book presents a wealth of current information on heating boilers ventilation ductwork air conditioning systems and methods refrigeration electrical systems control devices materials and equipment design and codes and standards. Filled with over 200 detailed illustrations and handy tip boxes on important code matters and exam questions, the HVAC Licensing Study Guide enables readers to:

* Develop skills with material most likely to appear on the NATE, ICE,. RSES, and HVAC licensing exams .
* Improve test-taking ability with over 800 exam-style multiple-choice. and true/false questions and answers .
* Learn about the latest refrigerant usage and regulations.
* Keep up with the most recent codes and standards.
* Acquire the confidence, skills, and knowledge needed to pass your. licensing exam on the first try


HVAC Fundamentals

HVAC Fundamentals covers the full range of HVAC systems used in today’s facilities. This is a comprehensive book providing the reader a detailed description of how HVAC systems operate. The HVAC systems are divided into components and controls for air, water, heating, ventilating and air conditioning to clearly illustrate the way in which each system, subsystem, control or component contributes to providing the desired indoor environment. The reader will learn why one component or system may be chosen over another with respect to design, application, energy conservation, indoor air quality and cost. The book also covers heat flow fundamentals and the heat flow calculations used in selecting equipment and determining system operating performance and costs. Fluid flow fundamentals and equations, and fundamentals of system testing and verification of system performance are also covered in this book. This gives the reader a complete picture of systems from conception to operation. The chapters are organized in a way that one builds upon another and systems, components, design and application are revisited as the reader gains knowledge and insight about the workings of HVAC systems.


Quality Engineering Handbook, Second Edition, Revised and Expanded (Quality and Reliability)

…a launching pad for those interested in mastering the field of quality engineering.
Journal of Quality Technology

…focused toward the goals of quality engineering, quality control, and continuous improvement…a fine effort.

…a launching pad for those interested in mastering the field of quality engineering.
Journal of Quality Technology

…focused toward the goals of quality engineering, quality control, and continuous improvement…a fine effort.


Written by the one of the foremost authorities on the subject, the Second Edition is completely revised to reflect the latest changes to the ASQ Body of Knowledge for the Certified Quality Engineer (CQE); covering every essential topic required by the quality engineer for day-to-day practices in planning, testing, finance, and management. Thoroughly examines and defines the principles and benefits of Six Sigma management and organization.


HVAC Water Chillers and Cooling Towers: Fundamentals, Application, and Operation

HVAC Water Chillers and Cooling Towers provides fundamental principles and practical techniques for the design, application, purchase, operation, and maintenance of water chillers and cooling towers. Written by a leading expert in the field, the book analyzes topics such as piping, water treatment, noise control, electrical service, and energy efficiency for optimal system and equipment performance and offers extensive checklists, troubleshooting strategies, and reference data, as well as recommended specifications for the procurement of new or replacement equipment. This reference also discusses proper installation and placement of chillers and cooling towers, start-up, and capacity. Very useful book for pharmaceutical engineers.


Handbook of Cosmetic Science and Technology, Third Edition

Edited by a team of experienced and internationally renowned contributors, the updated Third Edition is the standard reference for cosmetic chemists and dermatologists seeking the latest innovations and technology for the formulation, design, testing, use, and production of cosmetic products for skin, hair, and nails.

New features in the Third Edition:

39 new chapters reorganized by skin functions descriptions of ingredients, products, efficacy measurement, and mechanisms in each chapter revised chapters on skin types, skin perception, and targeted products new chapters on skin aging and cosmetics for the elderly strong emphasis on testing and current methods used for testing, and the evolution of instruments for skin and hair testing new ingredients, delivery systems, and testing methodologies information on skin physiology and cosmetic product design interactions affecting and attributed to cosmetic products cosmetic ingredients, vehicles, and finished products difference between pure cosmetics for enhancement and cosmetics used to treat high quality standards in cosmetic products that improve appearance, protect their targets, and maintain natural functions.


British Pharmacopoeia 2009

"The British Pharmacopoeia" ("BP") 2009 is the authoritative, current collection of standards for UK medicinal substances and the official source of all UK pharmaceutical quality standards. It is an essential reference for anyone involved in pharmaceutical research, development, manufacture and testing, and plays a vital role in ensuring that all medicinal substances on the UK market meet standards of safety, quality and efficacy.The "BP" comprises monographs, which set out the mandatory standards for active substances, excipients and formulated preparations, together with supporting General Notices, Appendices (test methods, reagents, etc) and Reference Spectra. Detailed information and guidance on various aspects of current pharmacopoeial policy and practice are provided in the Supplementary Chapters of the "BP".The "BP" is supplied in a variety of formats designed for ease of use and a wide range of applications. The hard copy edition comprises a five-volume boxed set containing the "BP" in four volumes and the "BP" (Veterinary) volume, plus single user access to the "BP" Online, the dedicated BP website. The online format is easy to network, allowing access for a specified number of users or across an entire organisation site.Following registration - using the ID code supplied with the hard copy - customers will be granted a single user licence to access BP on-line and will have the option to receive the CD-ROM, which contains the whole of the current "British Pharmacopoeia".It is effective as of 1 January 2009. It includes: a significant number of new UK monographs; all "European Pharmacopoeia 6th Edition" material up to and including "Supplement 6.2" integrated into the text of "BP 2009"; new and revised monographs for Complementary, Herbal and Homoeopathic medicines with their own section in Volume III; and networking with full technical support from TSO, the publisher of the "BP". The on-line version delivers the complete text of the "British Pharmacopoeia and European Pharmacopoeia" standards to your PC. The new features include an alphabetical index, user-friendly search interface design, and a facility to create a 'My BP' section." British Pharmacopoeia 2009" eBook - "The complete British Pharmacopoeia 2009" is now available exclusively to "BP 2009" purchasers in an innovative new format. The eBook is greatly suited to this large reference text making the information contained within it available to all of those who wish to access it on the move and away from their desks.British Pharmacopoeia 2009 Concurrent Licence (Online) - "The British Pharmacopoeia" is available as a network licence which can be used on a concurrent user basis. It allows a designated number of staff simultaneous access to the online version of the "British Pharmacopoeia 2009". Once set up, your workforce can then start using the BP at their convenience.

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Guidelines for Failure Modes and Effects Analysis for Medical Devices

Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis. Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

Guidelines for Process Hazards Analysis (PHA, HAZOP), Hazards Identification, and Risk Analysis

This unique manual is a comprehensive, easy-to-read overview of hazards analysis as it applies to the process and allied industries. The book begins by building a background in the technical definition of risk, past industrial incidents and their impacts, ensuing legislation, and the language and terms of the risk field. It addresses the different types of structured analytical techniques for conducting Process Hazards Analyses (PHA), provides a "What If" checklist, and shows how to organize and set up PHA sessions. Other topics include layout and siting considerations, Failure Modes and Effect Analysis (FMEA), human factors, loss of containment, and PHA team leadership issues.

Transporters as Targets for Drugs

Transporters are proteins which span the plasma membrane and regulate the traffic of small molecules in and out of the cell. Transporters play a particularly important role in chemical signalling between neurons in the CNS, where they act to control the concentration of neurotransmitters in the synapse. The majority of transporters which are actively being pursued as targets for drug discovery are CNS located and this reflects the history of the field which began with the tricyclic antidepressants (TCAs) over half a century ago. The use of transporter inhibition to regulate the synaptic concentrations of key neurotransmitters is an established approach in the discovery of psychiatric medications. This volume reviews advances in the field of transporters as targets for drug discovery in the last 10 years. The volume will be of interest to scientists engaged in drug research in the pharmaceutical industry, biotech and academia. Following an overview chapter, seven chapters written by leading experts in their area reflect a range of topics pertinent to the transporter field. General topics include recent advances in the structural biology of transporters and its impact on potential structure based drug design and the design of ligands for Positron Emission Tomography and the importance of molecular imaging in understanding early clinical data. Medicinal chemistry approaches are described outlining the discovery of selective serotonin, noradrenaline and dopamine reuptake inhibitors, current efforts towards the discovery of mixed re-uptake inhibitors with varied ‘flavours’ of monoamine inhibition, advances in the development of inhibitors for the glycine transporter and the discovery of subtype selective EAAT inhibitors. In addition to being an interesting read, the reader will receive a critical overview of progress made in this rapidly developing field.

Complete Guide to Prescription and Non-Prescription Drugs

Complete Guide to Prescription and Non-Prescription Drugs is organized by drug generic name, and in a few instances, by drug-class name.

A generic name is the official chemical name for a drug.
A brand name is a drug manufacturer's registered trademark for a generic drug.  A generic drug may have one or many brand names.

To find information about a generic drug:

1    From the Select Index menu, choose Index by Generic Drug.
2    Look in the alphabetical index for the drug you want, and double-click it.
3   The first screen of information will appear in the topic window on the right. This is the Basic Information topic for that generic drug.

To learn about a brand name drug:

1    From the Select Index menu, choose Index by Brand Name.
2    Look in the alphabetical index for the drug you want, and double-click it.
3    The first screen of information will appear in the topic window on the right. This is the Basic Information for the generic drug equivalent of the brand name drug you clicked on.


Univ. of Toronto, Canada. Reference summarizes the history and applications, techniques, and approaches to pharmacogenomics. Discusses new methodologies used to pinpoint genetic variants, latest techniques to achieve phenotypic interpretations, accurate disease gene identification, and more.

Writing Clinical Research Protocols: Ethical Considerations

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. 

* Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol
* Includes a chapter containing Case Histories
* Contains information on conducting clinical research within the pharmaceutical industry
* An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations 
* Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

Cannabis - A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References

In March 2001, the National Institutes of Health issued the following warning: "The number of Web sites offering health-related resources grows every day. Many sites provide valuable information, while others may have information that is unreliable or misleading." Furthermore, because of the rapid increase in Internet-based information, many hours can be wasted searching, selecting, and printing.This book was created for medical professionals, students, and members of the general public who want to conduct medical research using the most advanced tools available and spending the least amount of time doing so.

Powder and Bulk Engineering International, May 2009

Powder and Bulk Engineering International [ISSN 1098-6480] is published six times a year in January, March, May, July, September, and November by CSC Publishing, Inc., 1155 Northland Drive, St. Paul, MN 55120 USA.



NPE2009 preview


Selecting the correct mixer Carl Ewing
Glossary of mixing and blending terms
Equipment feature: Mixing and blending


Bin level indicators


Combining size and shape analyses for more precise particle characterization Nicolas Marchet
Equipment feature: Particle analysis


Aero conveyor: Gentle conveying for friable materials Nick Hayes


Guest editorial
Industry news
Supplier notes
Advertiser index
Product update

Reliable Design of Medical Devices, Second Edition

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Practical Design Control Implementation for Medical Devices

Bringing together, for the first time, the concepts of design control and reliability engineering, Practical Design Control Implementation helps you face the challenge of designing and developing products that comply with regulatory requirements and fulfill customer expectations. Written with all levels of management and technical personnel in mind, the authors demonstrate how successful design control implementation can result in fewer customer complaints and medical device reports, more satisfied customers, and faster time-to-market. Part One focuses on the practical aspects of design control implementation for medical devices. The fundamental concepts of design control are not new. What is new is the adoption by the FDA of these principles and their consequent enforcement. Also new to the medical device industry are the different technical concepts, tools, and techniques necessary to implement design control. In this section, each chapter provides practical advice and insight on the required FDA design control elements. Part Two explores the reliability of medical devices and how design control can influence that reliability. The book presents easy to understand examples of typical product design and development phases with the corresponding reliability and risk analysis tools such as failure modes and effects analysis (FMEA), hazard analysis, reliability planning, reliability prediction, design verification, and validation. The authors discuss the inter-relatedness of reliability engineering and design control and apply the concept to medical device design. Providing common sense explanations and guidance, Practical Design Control Implementation helps readers successfully execute design control and reliability engineering procedures that not only meet the FDA guidelines but also meet or exceed customer expectations.

Drug-Drug Interactions, Second Edition

Helping researchers predict drug interactions in a more accurate and effective manner, this comprehensive volume covers every critical aspect of metabolism-based drug-drug interactions, including preclinical, clinical, toxicological, regulatory, and marketing perspectives by renowned thought leaders in their respective fields. Thoroughly updated, the Second Edition reflects key developments in the field, including an improved understanding of the relationship between transporters and enzymes in drug metabolism and drug interactions. Formatted to benefit the reader, this source provides helpful case examples, representative enzyme systems, and computer-aided modeling, as well as 200 valuable tables, equations, drawings, and photographs to clarify key concepts.

Advanced Practical Medicinal Chemistry

The present compendium on Advanced Practical Medicinal Chemistry is designed specifically to serve as a text-cum-reference book not only intended for the advanced undergraduate and graduate students of Pharmacy specializing in pharmaceutical chemistry but also for the bulk-drug industrial researchers and academics who work intimately with medicinal compounds. It mainly comprises of four comprehensive chapters. First chapter is entirely devoted to Safety in Chemical Laboratory, which is an absolute must for each medicinal chemist. Second chapter is on Drug Synthesis and concentrates on three vital aspects, namely : conceptualization of a synthesis, reaction variants, and stereochemistry. Third chapter exclusively deals with Performing the Reactions and entails the wide range of latest laboratory techniques used in a good chemical laboratory to facilitate synthesis of drugs.

Fourth chapter is particularly focused and earmarked to Synthesis of Medicinal Compounds, and essentially include various cardinal aspects, such as :types of chemical reactions, organic name reactions (ONRs), and selected medicinal compounds. A galaxy of eighty carefully chosen medicinal compounds have been presented in an original unique style comprising of: chemical structure, synonym (s)/chemical name(s) theory chemicals required procedure precautions recrystallization theoretical yield/practical yield physical parameters uses, and questions for viva-voce.

It is hoped that Advanced Practical Medicinal Chemistry would certainly help to bridge existing gap and fill up the long needed vacuum in the synthesis of drugs in pharmaceutical chemistry departments, academics and bulk-drug industries, and may provide the basis for meaningful productive group discussions of synthetic problems on a broader perspective.

Pharmaceutical Experimental Design And Interpretation

This complete revision of Understanding Experimental Design and Interpretation in Pharmaceutics provides a comprehensive and up-to-date guide for anyone involved in planning pharmaceutical experiments and analysing the results.After a brief discussion of the underlying statistical techniques, the major methods of experimental design and evaluation, such as multivariate analysis, principal components analysis and sequential analysis, are examined. A comprehensive review of factorial design, covering classical, partial and block designs, leads to a description of methods of optimization, including model-independent and model-dependent methods such as response surface methodology and multicriteria decision making. A separate chapter applies these methods to mixture designs which are particularly relevant to pharmaceutical formulations. Each chapter draws on real examples from the pharmaceutical industry making the book a practical aid for all pharmaceutical researchers.

International Pharmaceutical Product Registration

This reference text for the pharmaceutical industry sets out the regulatory requirements of the authorities of the major world market. The editors identify major key technical and scientific areas in any application for marketing authorization.