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The Chronic Diseases, their Peculiar Nature and their Homeopathic Cure.

The Chronic Diseases, their Peculiar Nature and their Homeopathic Cure.
by Dr Samuel Hahnemann

Translated from the second enlarged German edition of 1835, by Prof. Louis H. Tafel. With annotations by Richard Hughes, M. D., Edited by Pemberton Dudley, M. D.

Whatever estimate Science may finally place upon the discoveries and doctrines of Hahnemann, and whatever measure of confidence in his therapeutic belief Posterity may accord or withhold, his personality and work have achieved a position which must render them perpetually historic. His teachings have been so interwoven with the entire fabric of medical progress during the last hundred years, and are so interlaced with the formative development of the incoming century, that neither the wear and tear of time nor the dissections of criticism will ever be able to dissociate them. They are destined, inevitably, to run through the texture of every page in the future annals of medicine.

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Encyclopedia of Pharmaceutical Technology, Third Edition - 6 Volume Set

Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to come, the Third Edition will offer completely new entries that cover critical issues in the field such as the impact of genomics, biotechnology, and implants on drug discovery, targeting, delivery, and formulation. In addition, it will address new regulatory issues, such as the changes in advertising regulations, and emerging FDA procedures.

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Handbook of Bioequivalence Testing

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.

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Quality Assurance in the Analytical Chemistry Laboratory

Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.

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Cosmetics Additives: An Industrial Guide

Describes about 4000 cosmetics additives currently available for industrial use, compiled from information from 84 manufacturers and distributors. The cosmetics and personal care products industry has a $60 billion market worldwide, and future growth is expected. In the US the market breaks down roughly into: hair care-20%, fragrances-20%, skin care-14%, makeup-17%, deodorants and skin and body lotions-10%, and oral care products-10%. Growth is expected in products targeting ethnic markets and working women. The book lists the following product information, as available, in the manufacturer’s own words: (1) Company name and product category, (2) Trade name and product number, (3) Product description. Also included are a Trade Name Index and a list of Suppliers’ Addresses.

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Imagine Homeopathy: A Book of Experiments, Images, and Metaphors

In this unique book, homeopath Chris Kurz offers a highly effective and unique approach to learning and importantly, retaining, all of the important concepts of homeopathy. Using vivid analogies & informal language, Kurz emphasizes the importance of true insight rather than memory.

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Stockley's Drug Interactions 7th Edition

Stockley's Drug Interactions, produced within the Martindale Editorial Team under Karen Baxter, remains the world's most comprehensive and authoritative reference book on drug interactions.
  • Contains detailed yet concise monographs
  • Covers interactions between therapeutic drugs, proprietary medicines, herbal medicines, foods, drinks, pesticides and some drugs of abuse
  • Based on published sources and fully referenced
  • A typical monograph contains a summary, clinical evidence for the interactions under discussion, the probable mechanism, clinical importance and management
  • Covers over 14,000 drug interactions
  • Contains over 2,800 monographs
  • Includes 17,600 references

Stockley's Drug Interactions provides the busy healthcare professional with quick and easy access to clinically relevant, evaluated and evidence-based information on drug interactions.


Analytical Chemistry for Technicians, Third Edition

Surpassing its bestselling predecessors, this thoroughly updated third edition is designed to be a powerful training tool for entry-level chemistry technicians. Analytical Chemistry for Technicians, Third Edition explains analytical chemistry and instrumental analysis principles and how to apply them in the real world. A unique feature of this edition is that it brings the workplace of the chemical technician into the classroom. With over 50 workplace scene sidebars, it offers stories and photographs of technicians and chemists working with the equipment or performing the techniques discussed in the text. The author incorporates knowledge gained from a number of American Chemical Society and PITTCON short courses and from personal visits to several laboratories at major chemical plants, where he determined firsthand what is important in the modern analytical laboratory. The book includes more than sixty experiments specifically relevant to the laboratory technician, along with a Questions and Problems section in each chapter. Analytical Chemistry for Technicians, Third Edition continues to offer the nuts and bolts of analytical chemistry while focusing on the practical aspects of training.

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Inorganic Mass Spectrometry: Fundamentals and Applications (Practical Spectroscopy, 23)

Providing a theoretical background for inorganic mass spectrometry, this text describes classical applications of four modern mass spectrometers - magnetic sector, quadrupole, time-of-flight, and ion trap - and illustrates how they have impacted elemental and isotopic analysis. The book features examples that concentrate on routine and non-routine applications of inorganic analysis techniques.

Acceleration and Improvement of Protein Identification by Mass Spectrometry

At present where protein identification and characterisation using mass spectrometry is a method of choice, this book is presenting a review of basic proteomic techniques. The second part of the book is related to the novel high throughput protein identification technique called the 'molecular scanner'.

Several protein identification techniques are described, especially the peptide mass fingerprint with MALDI-MS based method. E.g. ionisation process, matrix available, signal reproducibility and suppression effect, as well as date treatment for protein identification using bioinformatics tools.

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Free Energy Calculations in Rational Drug Design

Free energy calculations represent the most accurate computational method available for predicting enzyme inhibitor binding affinities. Advances in computer power in the 1990s enabled the practical application of these calculations in rationale drug design. This book represents the first comprehensive review of this growing area of research and covers the basic theory underlying the method, numerous state of the art strategies designed to improve throughput and dozen examples wherein free energy calculations were used to design and evaluate potential drug candidates.

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Pharmaceutical Dosage Forms:Disperse systems volume 1

Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.

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Hplc of Peptides and Proteins: Methods and Protocols

Hands-on experts from academia and industry comprehensively describe how to successfully perform all the critical HPLC techniques needed for the analysis of peptides and proteins. The methods range from commonly used techniques to those for capillary to large-scale preparative isolation. The authors have also presented a number of specific applications as case studies to illustrate the analytical approaches to a particular separation or assay challenge, with examples drawn from contemporary fields in biochemistry and biotechnology.

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Antimicrobial Chemotherapy

Instilling good prescribing habits in young doctors is essential for the benefit of patients and to preserve the value of the antibiotic revolution that altered medical practice in the second half of the twentieth century. These concerns underlie the approach taken in the new edition of this successful book. The text provides a comprehensive and up-to-date account of the principles of antimicrobial chemotherapy as an aid to informed, rational prescribing. Care is taken to address all aspects of antimicrobial drug use, including those specific to developed and developing countries of the world. The authors are international experts with a long standing interest in the role of education as a means of promoting an understanding of the benefits and limitations of antimicrobial chemotherapy in physicians, surgeons and other health care workers. The book offers a structured approach to the subject in four themed sections, each of several chapters. A historical introduction is followed by a section outlining the basic properties of antibacterial, antifungal, antiparasitic and antiviral (including antiretroviral) drugs. The next section explains the various facets of antimicrobial drug resistance - which threatens to undermine the continued efficacy of antimicrobial agents - and effective ways of countering the threat. Therapeutic use is covered in two sections: one introduces readers to the general principles that inform the rational prescribing of antimicrobial drugs; the second deals with practicalities of the use of antimicrobial agents in specific clinical conditions. The book ends with a description of the ways in which drugs are developed and marketed. There are extensive recommendations for further reading.

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NMR-MRI, µSR and Mössbauer Spectroscopies in Molecular Magnets

In the last years, after the discovery of molecular nanomagnets showing novel quantum effects, a renewed interest for the study of molecular magnetism and multifunctional molecular materials has emerged. These materials have triggered an intense research activity also in view of their possible applicabilities as, for example, as nanosized information storage units and as magnetic nanoparticles for bio-medicine. Several fundamental aspects of the microscopic static and dynamic properties of these molecular materials have been obtained by means of spectroscopies using local probes, as nuclei and muons.

In this book an extensive overview on the results obtained during the last decade and on recent achievements in the study of molecular magnets by means of Nuclear Magnetic Resonance, Muon Spin Rotation, Magnetic Resonance Imaging and Mossbauer techniques is presented. The aim is to introduce the reader to these techniques and to give a general background on their application to molecular spin systems.

Process Analytical Technology

This is a video presentation on Process Analytical Technology [PAT], if you want to download this video, please request for the same in request section.


Rifaximin, A Poorly Absorbed Antibiotic: Pharmacology and Clinical Use

Rifaximin is a semisynthetic rifamycin which is not absorbed from the gastrointestinal tract. It has been available in Europe and other countries for several years, and has recently been approved for treatment of traveler's diarrhea in the United States. Because of its broad spectrum of antimicrobial activity, rifaximin has been used with success in the treatment of infectious diarrhea, hepatic encephalopathy, small intestinal bacterial overgrowth, inflammatory bowel disease, and colonic diverticular disease. Potential indications include the irritable bowel syndrome and chronic constipation, Clostridium difficile infection and bowel preparation before colorectal surgery. In this publication both the present and future clinical use of rifaximin as well as the pharmacology behind it are extensively reviewed. Compiling the latest information on this remarkably active antibacterial agent, it will be an essential resource for infectiologists, gastroenterologists, and digestive surgeons alike.

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Batch Control Systems: Design, Application, and Implementation

This revision of the 1990 work by Thomas Fisher covers an introduction to batch processes; batch control system structures; batch control; batch communications and batch control system design. Hawkins offers a comprehensive analysis of the development and evolution of batch control from the original NAMUR model through the most current publications in the 88 series. Through examples, commentary, analogies and at times wry humor the author provides an in-depth philosophical discussion of how batch control and all manufacturing enterprises have been impacted by the work of 88. Hawkins in-depth coverage and practical insights make this book an indispensable tool for designers, control engineers, project engineers, and managers who desire to achieve the full cost and production benefits of implementing the 88 series.

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Coatings Technology: Fundamentals, Testing, and Processing Techniques

Drawn from the third edition of The Coatings Technology Handbook, this book focuses entirely on testing, experimental design, and strategies for selecting processing techniques in the coatings, adhesives, paints, and inks industries. Coatings Technology: Fundamentals, Testing, and Processing Techniques contains the latest coating and processing methods capable of satisfying increasingly precise, application-specific requirements. The book contains analytical techniques used to elucidate surface chemistry, adhesion, and other physical properties. It also presents practical methods, such as accelerated light stability tests, to compare the resistance of different materials to wear, UV light/fading, and weathering. Subsequent chapters explore the most suitable techniques and the equipment for applying materials to different substrates, depending on material properties, service needs, and substrate types. Considering metal and nonmetal coatings and substrates, the book highlights the most recent advances on ink-jet printing, electrodeposition, vapor/chemical deposition technologies, high-speed dispersion, and other cutting-edge methods. Coatings Technology: Fundamentals, Testing, and Processing Techniques provides the the necessary information for scientists and engineers to perform testing and determine what materials and processing technique is most suitable for their own applications.

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User Friendly Guide to Multivariate Calibration and Classification

The field of chemometrics in general and multivariate calibration and classification in particular is now an essential tool for many analytical techniques. This book provides a readable text, for non-mathematicians, as a introduction to these areas for people with little or moderate knowledge of chemometrics. The book has been designed in an atractive and easily read format, with many diagrams and the use of margin notes to highlight important features.

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Handbook of Water Analysis, Second Edition

Extensively revised and updated, Handbook of Water Analysis, Second Edition provides the most current analytical techniques for detecting compounds in water samples. Maintaining the detailed and accessible style of the original, this edition demonstrates water sampling and preservation methods by enumerating different ways to measure chemical and radiological characteristics and giving step-by-step descriptions of separation, residue determination, and clean-up techniques for a variety of fresh- and salt-water. It reveals new information regarding the analysis of endocrine disrupting compounds and residues of plastics as well as four new chapters on acrylamide, trihalomethanes, phthalates, and volatile organic compounds in water.


Practical HPLC Method Development, 2nd Edition

This revision brings the reader completely up to date on the evolving methods associated with increasingly more complex sample types analyzed using high-performance liquid chromatography, or HPLC. The book also incorporates updated discussions of many of the fundamental components of HPLC systems and practical issues associated with the use of this analytical method. This edition includes new or expanded treatments of sample preparation, computer assisted method development, as well as biochemical samples, and chiral separations.

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Practical Guidelines on Pharmaceutical Procurement for Countries with Small Procurement Agencies

Procurement is an important step for efficient drug management and supply, and has become a routine procedure in the existing drug management system in many countries. An effective procurement process ensures the availability of the right drugs in the right quantities, at reasonable prices, and at recognizable standards of quality. Problems can often be encountered if procurement is carried out without such a systematic process, for instance the needed medicines are out of stock, overstocks and wastage of resources, and purchase of low quality products.
Given the impact of procurement activities on the operation and effectiveness of health services, it is essential that these activities be performed by trained staff using sound procedures. Effective procurement is a collaborative process between the procurement office, with needs of trained staff and an appropriate management system, and committees which make decisions as to which drugs to buy, in what quantities and from which suppliers.
This booklet is especially intended for countries with small procurement agencies. It is intended to provide practical guidelines for the procurement process. Pre-qualification of suppliers receives special attention as a means of ensuring the purchase of products of good quality. An effective procurement process will make an important contribution to the establishment of a reliable and good quality health service.
WHO’s work in essential drugs is designed to support Member States to ensure the accessibilty of good quality essential medicines that are affordable and are rationally used. I hope this booklet will help the users to improve the efficiency of their drug supply systems through effective procurement.


Transdermal Drug Delivery, Second Edition

Completely revised, the Second Edition of Transdermal Drug Delivery presents discussions of the key issues pertinent to transdermal drug delivery. Covering the depth and breadth of the field, from physical chemistry and assessment of drug permeability to available enhancement technologies, to regulatory approval, the book examines topics necessary to the critical evaluation of a drug candidate's potential for delivery across the skin. It describes how to determine the transdermal permeability of drugs, how rationally to select candidates for transdermal delivery, how to choose chemical and/or physical methods to enhance skin transport, and how to solve regulatory issues.

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Pharmaceutical Process Engineering

Summarizing fundamental engineering principles and operations critical to converting bulk pharmaceutical products into patient-ready and appropriate drug delivery dosage forms, Pharmaceutical Process Engineering facilitates comprehensive understanding of the practical aspects of drug production in an accessible, step-by-step format. It provides a pharmaceutical perspective on unit operations that improves communication among diverse professionals in the field-from pharmaceutical researchers to chemical and industrial engineers-and fully covers the relationship of pharmaceutical development to the application of key concepts and major unit operations in pharmaceutical engineering.

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Basic Gas Chromatography

Gas Chromatography (GC) is undoubtedly the most widely used technique for the separation and analysis of volatile compounds. Yet comprehensive guides to contemporary GC theory and practice are surprisingly hard to find.
Basic Gas Chromatography fills this significant void in the GC literature. Written by two well-known practitioners and educators in GC, it offers thorough coverage of the basic principles and techniques of modern gas chromatography.
Designed to serve as a primer/working reference for bench chemists and as a textbook for upper-level undergraduate and graduate students, it presents the fundamentals in a straightforward and logical fashion. Theoretical issues are explained without complicated equations and derivations and always in terms of how they relate to practical operating principles. Timely, comprehensive, and accessible, Basic Gas Chromatography:
* Provides a balanced presentation of theory and practice
* Includes both capillary column and packed column chromatography
* Uses the new IUPAC terms throughout, cross-referenced to traditional terms and symbols
* Offers a wealth of helpful hints, step-by-step guidelines, and trouble-shooting tips
* Briefly covers GC-MS, headspace analysis, chiral analysis, solid phase microextraction, and other cutting-edge topics.

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A Century of Separation Science

A Century of Separation Science presents an extensive overview of the critical developments in separation science since 1900, covering recent advances in chromatography, electrophoresis, field-flow fractionation, countercurrent chromatography, and supercritical fluid chromatography for high-speed and high-throughput analysis.

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Design of Controlled Release Drug Delivery Systems

The goal of every drug delivery system is to deliver the precise amount of a drug at a pre-programmed rate to the desired location in order to achieve the drug level necessary for the treatment. An essential guide for biomedical engineers and pharmaceutical designers, this resource combines physicochemical principles with physiological processes to facilitate the design of systems that will deliver medication at the time and place it is most needed.

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Analysis, Fate and Removal of Pharmaceuticals in the Water Cycle

Pharmaceutically active substances are a class of new, so-called "emerging" contaminants that have raised great concern in recent years. Human and veterinary drugs are constantly being introduced into the environment, mainly as a result of the manufacturing process. Over a period of time, this level of chemical input may lead to long-term concentrations and promote continual, but unnoticed adverse effects on aquatic and terrestrial organisms. Analysis, Fate and Removal of Pharmaceuticals in the Water Cycle discusses state-of-the-art analytical methods for trace determination of pharmaceuticals in environmental samples while reviewing the fate and occurrence of pharmaceuticals in the water cycle (elimination in wastewater and drinking water treatment). Focus is given to the newest developments in the treatment technologies, such as membrane bioreactors and advance oxidation processes.

* Well-structured overview of latest developments in trace determination
* Concise and critical compilation of literature published over the last few years
* Focuses on new treatment technologies, such as membrane bioreactors and advance oxidation processes

Thin Layer Chromatography : A Modern Practical Approach (Rsc Chromatography Monographs)

Thin-Layer Chromatography (TLC) is a modern, reliable tool that complements other chromatographic techniques. This book provides a practical guide to the basic principles, procedures, and pitfalls on the practical application of TLC.

Thin Layer Chromatography: A Modern Practical Approach offers a sequence of chapters following the steps of the technique as the chromatographer would follow them. The chapters provide a choice of sorbent best suited to the separation intended, followed by pre-treatment required for the sample, applying the sample to the sorbent layer, development procedure, visualisation and detection, and finally quantification. Imaging and hyphenation techniques are described. The reasons why recommendations are made for specific and more general methods are covered. The book also provides an overview of some recent developments in the field.

This practical guide is an invaluable introduction to Thin-Layer Chromatography, and will be welcomed by undergraduate students and the practising chromatographer in industry and academia.

HPLC: A Practical Guide (Chromatography Monographs)

This book answers two basic questions regarding chromatography; it focuses on how compounds can high-performance liquid be separated and on why particular compounds are separated by liquid chromatographic methods. It consists of six chapters: Basic Concepts of HPLC; Instrumentation: Preparation, Testing and Selectivity of Stationary Phase Materials; Selection of the Eluent; Separation Based on an Improved Column Efficiency; Influence of
Physical Chemistry on Separations in Liquid Chromatography. The focus is on the basic considerations in liquid chromatography rather than the applications but there are also sections on trouble-shooting. The book is concerned mainly with the selection of a packing material and the preparation of the eluent. Theoretical optimization is demonstrated using the chromatography of simple chemicals, to aid the understanding of liquid chromatography by graduate students. The examples given go beyond what can be found in general textbooks
on liquid chromatography. The separations can be easily understood from the differences in properties of familiar compounds known to undergraduate students.
The chromatographic separations described are based on solubility using molecular properties. The selection of chromatographic mode and column is analysed using solubility parameters. The separation factor cc is described in detail by physical and chemical parameters. Discussion of instrumentation focuses on high-efficiency operation and is concerned with degassing, the time constant, flow cell design, connectors and trouble-shooting. Packing materials and their synthesis and surface modification, liquid chromatographic analysis of surface activity and the evaluation of packed columns, including the measurement of void volume, are also considered.

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Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential core task when establishing and maintaining compliance with global regulatory authorities, such as the FDA and the MHRA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.

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Laboratory Design, Construction, and Renovation: Participants, Process, and Product

Laboratory facilities are complex, technically sophisticated, and mechanically intensive structures that are expensive to build and to maintain. Hundreds of decisions must be made before and during new construction or renovation that will determine how successfully the facility will function when completed and how successfully it can be maintained once put into service.

This book provides guidance on effective approaches for building laboratory facilities in the chemical and biochemical sciences. It contains both basic and laboratory-specific information addressed to the user community-the scientists and administrators who contract with design and construction experts. The book will also be important to the design and construction communities-the architects, laboratory designers, and engineers who will design the facility and the construction personnel who will build it-to help them communicate with the scientific community for whom they build laboratory facilities.

Handbook of Process Chromatography, Second Edition: Development, Manufacturing, Validation and Economics

This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.

Updates include:

- sources and productivity
- types of products made today
- experiences in clinical and licensed products
- economics
- current status of validation
- illustrations and tables
- automated column packing
- automated systems

New topics include:

- the use of disposables
- multiproduct versus dedicated production
- design principles for chromatography media and filters
- ultrafiltration principles and optimization
- risk assessments
- characterization studies
- design space
- platform technologies
- process analytical technologies (PATs)
- biogenerics
- comparability assessments

Key Features:

- new approaches to process optimiaztion
- use of patform technologies
- applying risk assessment to process design

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Managing the Analytical Laboratory: Plain and Simple

A clear, concise manual on how to run a quality control testing laboratory efficiently and in compliance with all regulations, this book provides hundreds of tips and techniques that help the reader focus on the essential elements of good laboratory management. It presents thirty-nine useful SOPs that have evolved from the author's years of practical experience. Fifteen case studies describe typical laboratory problems and offer possible solutions. From how to train analysts, to how to lay out the laboratory, to how to assure that samples are processed in a systematic manner, Managing the Analytical Laboratory: Plain and Simple covers it all.

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HPLC Method Development for Pharmaceuticals, Volume 8

High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective.

HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.

* Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory
* Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities)
* Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

ISO 14001 Environmental Certification Step by Step: Revised Edition

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

HVAC Systems and Components Handbook

With this authoritative reference at hand, engineers and technicians will gain full knowledge of each component in today Õs complex heating, ventilating, and air conditioning systems. Completely revised and fully updated, this second edition of a widely used working tool offers: Analyses of today Õs most efficient, most trouble-free systems ... Details on todays highly advanced components ... Ways to achieve economy and efficiency in design ... clear explanations of the environmental impact of HVAC design ... Information on meeting key codes and standards. Featuring contributions from the top companies in HVAC technology ÑYork, Allied Signal, Honeywell, and SverdrupÑthe Handbook is an ideal source of reliable and timely information and advice on HVAC systems and components.

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Clinical Drug Trials and Tribulations, Second Edition

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on… · international regulation and deregulation · venture capitalist investment · the IND process · informed consent · changes in manufacturing and updated and extended coverage of… · pediatric drug trial design · the advantages and disadvantages of orphan drug designations · the maximization of package inserts for marketing · post approval safety surveillance · withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

SAS Programming in the Pharmaceutical Industry

At last! A real-world reference guide for clinical trial SAS programming, packed with solutions that programmers can apply to their day-to-day problems. Discover key techniques and tools available within Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to resolve many common issues in working with clinical trial data. Organized to reflect the statistical programmer's work flow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. Valuable plug-and-play programming examples are provided throughout. Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical suggestions to help you sharpen your skills.

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Management of Data in Clinical Trials

A valuable new edition of the trusted, practical guide to managing data in clinical trials

Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided.

While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.

Newly featured topics include:
*The growing availability of "off-the-shelf" solutions for clinical trials
*Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry
*The increasing use of the Internet in the collection of data and management of trials
*Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines
*Development of Standard Operating Procedures for the conduct of clinical trials

Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Clinical Trials Risk Management

Focusing on the day-to-day needs of a clinical trials manager, this book explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to 'real life' clinical trial situations. After building a foundation of basic principles, the authors lead readers through specific methods for handling the risks characteristically encountered in clinical trials. They discuss concepts using worked examples and include a summary of the main points at the end of each chapter. In addition to diagrams and Risk and Precision Tree charts, the text is sprinkled with humorous line drawings that reinforce the concepts.

Enhancement in Drug Delivery

Enhancement in Drug Delivery offers an accessible compendium covering a wide spectrum of methods to enhance drug delivery and absorption by various routes of administration. Drawing from a number of disciplines, it gives students and practitioners in pharmaceutics, medicine, and health-related disciplines a much-needed guide to current practices. It also provides a starting place for those working on delivery systems for new drugs or seeking to improve current systems by drawing on means applied in other routes. Organized by routes of delivery, the book covers oral, rectal, buccal and sublingual, dermal and transdermal, ocular, vaginal and uterine, nasal and brain administrations.

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Hplc and Ce Principles and Practice

HPLC and CE: Principles and Practice presents the latest information on the most powerful separation techniques available: high-performance liquid chromatography (HPLC) and capillary electrophoresis (CE). Fundamental theory, instrumentation, modes of operation, and optimization of separations are presented in a concise, non-technical style to help the user in choosing the appropriate technique quickly and accurately. Well- illustrated and containing convenientend-of-chapter summaries of the major concepts, the book provides in-depth coverage of trouble-shooting, improvement of resolution, data manipulation, selectivity, and sensitivity.
Graduate students, technicians, and researchers who must use separations with little or no background in analytical chemistry can overcome separation anxiety and get started in obtaining the best possible separations in minimal time. The book will alsobe useful to analytical chemists who need a better understanding of theory and processes.

Key Features
* Fully up-to-date information on both HPLC and CE includes troubleshooting and comparisons of the two techniques
* Applicable to a wide variety of separation problems
* Covers basic concepts governing any separation as well as instrumentation and how to use it
* Helps the user to obtain optimal resolution in minimal time
* Contains information on special procedures such as chiral separations, affinity chromatography, and sample preparation
* Includes information on upcoming trends such as miniaturization
* Major concepts in each chapter are organized to allow access to information easily and quickly
* Contains practical bibliography for accessing the literature

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New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than forty respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.

Pharmaceutical Process Validation: An International Third Edition

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

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Drugs and Controlled Substances Information for Students

Drugs and Controlled Substances: Information for Students is a medical reference product designed to inform and educate readers about a wide variety of drugs and controlled substances. The Gale Group believes the product to be comprehensive, but not necessarily definitive. It is intended to supplement, not replace, consultation with a physician or other health care practitioner. While the Gale Group has made substantial efforts to provide information that is accurate, comprehensive, and up-to-date, the Gale Group makes no representations or warranties of any kind, including without limitation, warranties of merchantability or fitnessfor a particular purpose, nor does it guarantee the accuracy, comprehensiveness, or timeliness of the information contained in this product. Readers should be aware that the universe of medical knowledge is constantly growing and changing, and that differences of medical opinion exist among authorities. Readers are also advised to seek professional diagnosis and treatment of any possible substance abuse problem, and to discuss information obtained from this book with their health care provider.

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Advanced Pharmaceutical Solids

This extensive reference/text explores the principles, instrumentation, processes, and programs of pharmaceutical solid science as well as new aspects on one-component systems, micromeritics, polymorphism, solid-state stability, cohesion, powder flow, blending, single- unit sustained release, and tablet coating. Reveals unique approaches in pharmaceutical solid science not previously published in any other text! Providing current data on crystallization, dissolution from particles and polydisperse populations, powder volumes and densities, comminution, wet granulation, and hard-shell capsules, Advanced Pharmaceutical Solids · describes moisture isotherms with crystalline solids · documents the effects of moisture on solid-state stability · highlights tablet physics and principles · explains sustained release by microencapsulation · presents prediction equations for solubility in binary solvents · discusses particle sizes and diameters · identifies Brunauer, Emmett, and Teller Isotherms · and more! Considering properties of solids, permeamitry and gas absorption methods, amorphates, and purification by pH-change precipitation, Advanced Pharmaceutical Solids is an essential reference for pharmacists; pharmaceutical scientists; medicinal, physical, surface, colloid, and analytical chemists and biochemists; and an effective text for upper-level undergraduate and graduate students in these disciplines.

Handbook of Industrial Crystallization, Second Edition (Purification of Laboratory Chemicals)

Crystallization is an important separation and purification process used in industries ranging from bulk commodity chemicals to specialty chemicals and pharmaceuticals. In recent years, a number of environmental applications have also come to rely on crystallization in waste treatment and recycling processes.

The authors provide an introduction to the field of newcomers and a reference to those involved in the various aspects of industrial crystallization. It is a complete volume covering all aspects of industrial crystallization, including material related to both fundamentals and applications. This new edition presents detailed material on crystallization of biomolecules, precipitation, impurity-crystal interactions, solubility, and design.

Provides an ideal introduction for industrial crystallization newcomers
Serves as a worthwhile reference to anyone involved in the field
Covers all aspects of industrial crystallization in a single, complete volume

Statistical Thinking for Non Statisticians in Drug Regulation

Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statistician working within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context. As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation.

Statistical Thinking for Clinical Trials in Drug Regulation:

  • Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language
  • Improves the ability to read and understand statistical methodology in papers and reports and to critically appraise that methodology
  • Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)