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Handbook of Aqueous Solubility Data

Over the years researchers have reported solubility data in the chemical, pharmaceutical, engineering, and environmental literature for several thousand organic compounds. Until now, this information has been scattered throughout the literature. Containing over 16,000 solubility data points for more than 4,000 organic compounds, Handbook of Aqueous Solubility Data provides an extensive compilation of published aqueous solubility data for a wide variety of organic nonelectrolytes and unionized weak electrolytes. It includes data for pharmaceuticals, pollutants, nutrients, herbicides, pesticides, agricultural, industrial, and energy related compounds. Each compound is identified by a sequential number along with molecular formula, compound name, synonyms, molecular weight, CAS Registry Number, melting point, and boiling point if available. Each entry has a five-point evaluation score for the quality of the reporting of the data, along with the full citation, and comments from the authors when necessary. The user-friendly format gives a clear depiction of each piece of solubility data with enough information to estimate its validity. Handbook of Aqueous Solubility Data gives you a portable, accessible resource for solubility data of numerous compounds and a single system for the evaluation of the data supplied.


Medical Pharmacology at a Glance, 4th Edition

"Medical Pharmacology at a Glance" is one of the most renowned undergraduate texts in the field of medical pharmacology. Following on from the success of the previous three editions, Professor Michael Neal, one of the great teachers of medical pharmacology, has extensively revised and updated the fourth edition to take account of the rapid developments in the field. This incredibly useful book summarises the core principles of the mode of action of drugs and puts this information within the context of body systems and specific clinical problems. The author discusses the mechanisms of action of each drug, indicating the therapeutics of choice for specific conditions. "Medical Pharmacology at a Glance" follows the now familiar, easy-to-use double page spread format of the at a Glance series. Each section contains a clear illustration depicting the major drugs and their interaction within a particular body system and a concise account of the topic. Key features of the fourth edition include: new material on anti-platelet drugs in the cardiovascular section; new section on immunological drugs; new material on general anaesthetic and anti-viral drugs; and the use of Recommended International Non-proprietary Names (rINN) for drugs. "Medical Pharmacology at a Glance" is ideal for pharmacology revision and for use during clinical placements. It is an essential buy for medical students and scientists requiring a succinct and lucid account of medical pharmacology.


Advances in LC-MS Instrumentation, Volume 72

The different LC-MS techniques available today were developed to suit specific analytical needs and the application range covered by each one is wide, but still limited. GC amenable compounds can be all analyzed with a single GC-MS system whereas HPLC applications call for specific LC-MS instrumental arrangements. ESI, APCI, APPI, and EI are ionization techniques that can be combined with different analyzers, in single or tandem configuration, to create the ultimate system for a certain application. Once approaching LC-MS for a specific need, the fast technical evolution and the variegated commercial offer can induce confusion in the potential user.

The role of this book is to enlighten the state-of-the-art of LC-MS evolution through a series of contributions written by the people that brought major, recent innovations in the field. Each chapter will take into consideration the novelties, the advantages and the possible applications covered by a particular technical solution. The book will also include new analytical methods that can provide benefits using the most recent innovations in LC-MS plus a certain number of key applications.

- Contains contributions from major innovators in the field
- Covers the latest developments in the field of LC-MS
- Gives a clear outline on the advantages of various techniques and their applications

Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

A Practical Guide to Microbial Limit Methodologies

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Includes New and Updated Material

Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.

Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

Encyclopedia of Clinical Pharmacy

This reference presents the latest procedures, practice guidelines, consensus documents, technological strategies, and regulatory standards for optimal pharmaceutical care--offering summaries for practical applications in a variety of clinical settings, including community and health-system pharmacies, clinics, hospice and long-term care facilities, government agencies, and pharmaceutical research and development organizations.


Technology Transfer in Biotechnology: From Lab to Industry to Production

Several new methods besides the usual organic solvent extraction have been developed over the last few years for the extraction of primary and secondary metabolites. These are: alcohol extraction with various biocompatible solvents, recovery of carboxylic acids and antibiotics with reactive extraction, dissociation extraction, aqueous two-phase extraction, and supercritical and near critical fluid extraction.Extraction and re-extraction processes are integrated into a single step by emulsion liquid membrane and solid supported liquid membrane extractions. These extraction processes are discussed and compared in this review, along with extraction with reversed micelles, and reactive extraction with the formation of a third phase at the organic-aqueous interface.


In Vitro Methods in Pharmaceutical Research

In Vitro Methods in Pharmaceutical Research provides a comprehensive guide to laboratory techniques for evaluating in vitro organ toxicity using cellular models. Step-by-step practical tips on how to perform and interpret assays for drug metabolism and toxicity assessment are provided, along with a comparison of different techniques available. It is a welcome addition to the literature at a time when interest is growing in cellular in vitro models for toxicology and pharmacology studies.

Key Features
* Meets the continuing demand for information in this field
* Compares In Vitro techniques with other methods
* Describes cell-culture methods used to investigate toxicity in cells derived from different organs
* Includes contributions by leading experts in the field

Technology Transfer: A Practical Guide

There can be few pharmaceutical companies over the last 15 years that have not undergone the maelstrom of take-overs, mergers, downsizing, centres of excellence or product rationalisation. All these events can, and frequently do, result in product or products being transferred between manufacturing sites. At best it will be a product or product type that the receiving site is familiar with, or at worst, one with which they are totally unfamiliar.
The challenges to effect technology transfer in a timely fashion, within budget and achieving savings that have probably been pre-commirted, at the requisite quality are approximately the same for each aspect. This guide provides a "ready reckoner" of the issues to be considered to achieve these objectives, ensuring that the regulatory issues from both a licensing and inspection
perspective are addressed, and maintaining the organisation's integrity for its products and with its shareholders. In considering the technology transfer process reference is made to the situation within the European Union (EU) in the main; however, where useful guides or proposals are available from other regulatory authorities, notably the FDA, these have been included for completeness.


Drug Delivery Systems, Second Edition

Drug delivery technologies represent a vast and vital area of Research and Development. The demand for innovative drug delivery systems continues to grow, and this growth continues to drive new developments. Building on the foundation provided by the first edition, Drug Delivery Systems, Second Edition covers the latest developments in both industry and academia. New in this edition: · Chapter focusing on novel technologies and their global outlook · Coverage of electronically controlled drug delivery · Macrocapsules and nanoparticles in drug targeting · Drug nanocrystals and other new delivery systems · Updated information on liposomes as carriers Written in a straightforward, clear, and concise manner, the author provides a global perspective on current and future advances and market opportunities. Drug Delivery Systems, Second Edition answers the need for comprehensive information in a single resource for anyone venturing into this area of drug development.


Drug Absorption Studies: In Situ, In Vitro and In Silico Models

In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models offer a fast, convenient approach with cost advantages most of times. Most importantly, they can be standardised and automatised to be applicable to the high-throughput screening.

Starting at the molecular level of studies, continuing with cell monolayer models (both primary and cell lines) and in situ techniques as a final testing format, the book provides a practical approach to contemporary in vitro techniques for drug absorption studies. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix comprised with a number of practical protocols is available online, updated as needed, should prove very helpful to apply the techniques directly to the benchside.

Color Atlas of Pharmacology, 3rd Edition

Updated with the most important new substances and scientific developments, the third edition of The Color Atlas of Pharmacology makes it easier than ever for students, nurses, and practicing physicians to keep up with the latest developments in this constantly changing field. Featuring a user-friendly layout, jargon-free language, and more than 160 spectacular color charts and illustrations, the atlas is divided in to four, color-coded sections:

Part 1 - General pharmacology - includes descriptions of substance formulation, absorption, distribution, elimination, and molecular mechanisms of action Part 2 - Systems pharmacology - with special emphasis on the functional and therapeutic aspects of a wide range of medicinal agents Part 3 - Therapy of selected diseases - such as osteoporosis, acute myocardial infarction, migraine, asthma, tropical diseases, and many more Part 4 - Drug Index - helpfully listed by substance, generic, and brand names

Concise, portable, and packed with information, the third edition of The Color Atlas of Pharmacology is the most practical first-stop reference for today's busy healthcare professional.

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Photostability of Drugs and Drug Formulations

This text discusses various aspects of the combination of drugs and light. Degradation processes, stabilization of photolabile drug substances within formulations, benefits from the combination of drugs and light, and testing of drug photoreactivity, are some of the topics discussed.


Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.


Assessing Bioavailablility of Drug Delivery Systems: Mathematical Modeling

This book introduces mathematical modeling methods for calculating the profiles of plasma levels obtained with controlled release dosage forms and provides examples and case studies to illustrate the techniques employed. The mathematical models developed by the author are particularly powerful because they account for such major parameters as the kinetics of drug release controlled by diffusion or by erosion, and the kinetics of absorption into and elimination out of the plasma. They are also able to solve the problem of determining the drug level in plasma as a result of patient non-compliance, incorrect dosage, and incorrect frequency, and to determine the best dosage forms necessary for therapy.


Understanding Drug Release and Absorption Mechanisms: A Physical and Mathematical Approach

Demand for better reliability from drug delivery systems has caused designers and researchers to move away from trial-and-error approaches and toward model-based methods of product development. Developing such models requires cross-disciplinary physical, mathematical, and physiological knowledge. Combining these areas under a single cover, Understanding Drug Release and Absorption Mechanisms builds a firm understanding ofall elements needed to conceive, build, and implement successful models of drug release.

Written by experts with broad industrial and academic experience, this book discusses the underlying physical principles, shows how to build mathematical models based on these principles, and finally compares the resulting models with experimental results. The authors begin by introducing the basics of modeling, physiological details of gastrointestinal and dermal absorption pathways, rheology, mass transport and thermodynamics, dissolution and partitioning, as well as size effects on the dissolution of crystallites. From this baseline, the authors explore applications in drug release from various delivery systems, specifically matrix systems, microemulsions, and permeability through membranes.

Working systematically from theory to working models, Understanding Drug Release and Absorption Mechanisms: A Physical and Mathematical Approach demonstrates the steps involved in designing, building, and implementing realistic and reliable models of drug release without unrealistically simplifying the theoretical parameters.


Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics: Homogeneous and Heterogeneous Approaches

The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with empirical, compartmental, and stochastic pharmacokinetic models, and the fourth mainly with nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. Many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.

This timely and useful book will appeal to graduate students and researchers in pharmacology, pharmaceutical sciences, bioengineering, and physiology.


Cyclic Gmp: Synthesis, Metabolism, and Function

This volume is dedicated to the topic of cyclic GMP. Chapters include discussions on the guanylyl cyclase and phosphodiesterase isoenzyme families for cyclic GMP synthesis and hydrolysis, cyclic GMP-dependent protein kinases, and various hormones and ligands that regulate cyclic GMP formation and/or metabolism. Several chapters also deal with some of the effects of cyclic GMP on other second messengers such as calcium ion transport and smooth muscle relaxation. Some clinical studies with cyclic GMP and atrial natriuretic peptide are also discussed. The last chapter raises many important questions in the field that remain to be addressed.

Key Features
* Isoforms of guanylyl cyclase and phosphodiesterase isoenzyme families for cyclic GMP synthesis and hydrolysis
* Cyclic GMP-dependent protein kinase
* Hormones and ligands that regulate GMP formation and/or metabolism
* Effects of cyclic GMP on other second messengers and some functions such as smooth muscle relaxation and ion transport
* Clinical studies with cyclic GMP and atrial natriuretic peptide
* Important questions and experiments for the future.


All ICH Guidelines

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

HVAC: Systems and Equipment (SI Edition)

The 2008 ASHRAE Handbook—HVAC Systems and Equipment discusses various systems and the equipment (components or assemblies) that comprise them, and describes features and differences. This information helps system designers and operators in selecting and using equipment.


Air Conditioning System Design Manual

The Air Conditioning Manual was written to assist entry-level engineers in the design of air-conditioning systems. It is also suable -- in conjuction with fundamental HVAC&R resourcee material -- as a senior- or graduate-level text for a university course in HVAC system design. The manual was written to fill the void between theory and practice -- to bridge the gap between real-world design practices and the theoretical caluclations and analytical procedures or on the design of components.


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This highly acclaimed textbook is a worldwide bestseller, recognized for its emphasis on the mechanisms by which drugs act at the cellular and molecular levels and how that relates to their overall pharmacological effects and clinical uses. The 5th Edition includes four new chapters, a reorganized and expanded section on treatments for infections and cancer, and thorough updates throughout that explore new treatments and advances in molecular biology that may lead to future therapeutic options for cancer, HIV infection, osteoporosis, neurodegenerative disorders, erectile dysfunction, obesity, diabetes, atherosclerosis, cardiac failure, and more. User-friendly features include new chapter overviews reviews of relevant physiology and biochemistry boxed key points and clinical uses references and reading lists a new full-color art program and new "small print" sections that separate the more complex material from the main discussion thread in each chapter, leaving the depth of coverage to the reader's discretion.


Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices


Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.

Topics covered include:

  • Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.
  • Post-approval considerations and regulatory filing strategies to support a global supply chain.
  • Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications.
  • Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products.
  • Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).
  • USP-NF testing in support of stability.
  • Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing.
  • Discussion of matrixing and bracketing to support reduced stability testing.
  • Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

AHFS Drug Information

Annual reference provides a comprehensive evidence-based collection of more than 1,000 drug monographs. Each listing includes FDA-approved uses, evidence-based coverage of off-label uses, drug interactions, cautions, toxicity, dosage recommendations, coverage of pharmacology and pharmacokinetics, and more. For pharmacists and other healthcare professionals. Softcover.


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Handbook of Chemical Industry Labeling

Presents, for the first time in one volume, a concise treatment of labeling in the chemical industry. This handbook has been designed to provide an in-depth review of, and to act as a source for, the major elements of a hazardous label communication program—to serve the needs of labor, industry, and the public.


Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification

Since 1997, the Institute of Medicine has issued a series of nutrient reference values that are collectively termed Dietary Reference Intakes (DRIs). The DRIs offer quantitative estimates of nutrient intakes to be used for planning and assessing diets. Using the information from these reports, this newest volume in the DRI series focuses on how the DRIs, and the science for each nutrient in the DRI reports, can be used to develop current and appropriate reference values for nutrition labeling and food fortification.

Focusing its analysis on the existing DRIs, the book examines the purpose of nutrition labeling, current labeling practices in the United States and Canada, food fortification practices and policies, and offers recommendations as a series of guiding principles to assist the regulatory agencies that oversee food labeling and fortification in the United States and Canada. The overarching goal of the information in this book is to provide updated nutrition labeling that consumers can use to compare products and make informed food choices. Diet-related chronic diseases are a leading cause of preventable deaths in the United States and Canada and helping customers make healthy food choices has never been more important.

Pharmacy Law: Textbook & Review

A concise, two-in-one review of pharmacy law-ideal for coursework and MPJE® exam prep!

This accessible, real-world guide gets you ready for the practice of pharmacy, while giving you the proper training to be compliant with the law. To that end, the book expertly covers relevant laws, rules, and regulations, and it highlights the distinctions between state and federal law where appropriate. In no other reference can you find such a succinct, yet thorough review of the full range of federal pharmacy laws, including the Controlled Substances Act, the Food, Drug, and Cosmetics Act, the new Dietary Supplement Health Education Act, the FDA Modernization Act, and the Medicare Modernization Act.


  • An excellent primer for coursework and unbeatable preparation for licensure and the MPJE®
  • Opening chapter on drug regulation and standards provides you with a practical legal framework for subsequent chapter material
  • Overview of the drug approval process and federal reporting programs
  • Chapter on internet sales and FDA authority to act
  • Coverage of opioid addiction treatment and narcotic treatment programs, giving you a unique close-up of the latest laws and policies
  • Comprehensive set of 450 multiple-choice questions and answers
  • Chapter of MPJE®-format practice questions

Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives

The international popularity of herbal remedies has recently outpaced quality information on the utilization and dosing of these compounds. This book fills a void in the literature by offering an authoritative overview of the mechanisms of herbal remedies and their impact on standard medications. It offers a practical approach that focuses not only on specific drug interactions, but the mechanisms behind those interactions and their clinical significance. With contributions from leading experts on the subject, this text examines the overall use of herbs, includes sections on individual herbs, and considers pertinent regulatory issues and concerns in industry.


Statistical Design and Analysis of Stability Studies

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.


Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago, drug discovery and evaluation was a sequential process starting with the selection of the most active compound from a series of newly synthesized compounds by means of special pharmacological assays. Safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity. Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails.

This "sequential" strategy has been abandoned for several reasons:

- Some negative effects on organ function, e.g. ventricular tachy-arrhythmia, were detected too late. On the other hand, negative findings in chronic toxicity studies in animals turned out to be irrelevant for human beings.

- New scientific approaches, e.g. combinatorial chemistry, high-throughput screening, in silico models, pharmaco-genomics and pharmaco-proteomics offered new possibilities.

- There are several examples which show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed.

The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. A change of strategy was therefore adopted, involving the following changes:

- Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization).

- The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group. Easily accessible and the most informative tests now have to be selected.

- Exposure of a drug to the body by pharmacokinetic studies on absorption, distribution, metabolism and excretion has to be investigated at an early stage of development and can contribute to the selection of a compound for development.

Toxicology experienced major achievements by the introduction of new methods, e.g., in silico methods, toxicogenomics and toxicoproteomics.

The book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs.

The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.

In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.

Liquid Chromatography Column Theory

Offers comprehensive coverage of all the theoretical aspects of chromatography columns beginning with very simple concepts which describe their properties. Topics include peak capacity, column overload, thermal effects and many other chromatographic phenomena. Provides in-depth discussions of both the plate and rate theories as well as the design of the optimum column, analytical packed and open tubular columns. Includes practical examples of the use of these theories and equations derived from them.


Surface Contamination and Cleaning

This volume documents the proceedings of the International Symposium on Surface Contamination and Cleaning, held in Newark, New Jersey, May 23-25, 2001. Because of the importance of this topic in many technological areas, tremendous efforts have been devoted to devise novel and more efficient ways to monitor, analyse and characterize contamination on surfaces as well as ways to remove such contamination from a wide variety of surfaces. The technological areas where surface contamination has always been a bete noire and thus surface cleaning is of cardinal importance are too many and range from aerospace to microelectronics to biomedical. This volume contains a total of 24 papers, all rigorously peer reviewed and revised before inclusion, which deal with all kinds of contaminations on a host of surfaces. The topics covered include: mapping of surface contaminants; various techniques for cleaning surfaces; various techniques for monitoring level of cleanliness; acceptable cleanliness levels; ionic contamination; pharmaceutical cleaning validations; cleaning of glass surfaces; decontamination of sensitive equipment; no-chemistry process cleaning; waterjet cleaning; cleaning with solid carbon dioxide pellet blasting; cleanroom wipers; dust removal from solar panels and spacecraft on Mars; laser cleaning of silicon surfaces; particle removal; implications of surface contamination and cleaning; and future of industrial cleaning and related public policy-making. This volume offers a wealth of information and represents current commentary on the R&D activity taking place in the technologically highly important field of surface contamination and cleaning and should be of value and interest to anyone interested in the fundamental or applied aspects of this topic.


The Veterinary Formulary

The sixth edition of The Veterinary Formulary has been updated and revised by 51 expert contributors and reviewed by an advisory committee of veterinarians and pharmacologists. Features of this edition include: Revision of over 780 drug monographs from the fifth edition Some 55 new drug monographs Over 1650 UK veterinary preparations Preparation and dosage details for over 700 human-authorised products Existing sections re-arranged to reflect current veterinary practice Many new sections, eg Prescribing for rabbits, Canine pheromonatherapy, and Teat sealants New table giving husbandry requirements for common pet terrestrial invertebrates Revised BVA code of practice on medicines - includes essential legislation and information New easy-to-read appendix on Drug interactions.


Controlled Environments - November 2008



Matt Kopecky




Bikash Chatterjee



Barbara Kanegsberg and Ed Kanegsberg








Pharmacotherapy: A Pathophysiologic Approach

The benchmark evidence-based pharmacotherapy text-now in full color!

Additional chapters are available online

When it comes to helping you develop a mastery of evidence-based medicine for optimal patient outcomes, no book can match Pharmacotherapy: A Pathophysiologic Approach. Like the discipline it covers, the scope of this trusted resource goes beyond drug indications and dosages to include the initial selection, proper administration, and monitoring of drugs.

The book also delves into psychosocial issues that affect compliance … topics related to a patient's ability to understand and manage often-complex therapy… and lifestyle changes that may reduce the need for drug therapy or improve pharmacotherapeutic outcomes. Pharmacotherapy delivers everything you need to provide safe, efficacious drug therapy across the full range of therapeutic categories.


  • NEW! Expanded evidence-based recommendations
  • NEW! Extended coverage of the timely issue of palliative care and pain medicine
  • NEW! Important chapters on Pulmonary Hypertension, Disorders of Calcium and Phosphorus Homeostasis, and Multiple Myeloma,
  • Outstanding pedagogy, including:
  • “Key Concepts” highlighted in each chapter
  • “Clinical Presentation” boxes summarize the most common disease signs and symptoms covered in each chapter
  • “Clinical Controversies” boxes-presented in the Treatment sections of the disease-oriented chapters-examine the complicated issues faced by students and clinicians in providing drug therapy
  • Clear therapeutic recommendations in each disease-specific chapter
  • “Evaluation of Therapeutic Outcomes” boxes in each disease-specific chapter, containing key monitoring guidelines that facilitate the development of a pharmaceutical, nursing, or medical care plan

Environmental Risk Assessment

This book gives a broad overview of approaches and experiences on how to assess ecological and human information on health risks. The chapters are targeted to different users. As an example , industrial applications are described, also addressing the need of risk assessments for SMEs. The need of science and policy roles are described. Links to information sources, organisations, software models, EU legislation, and publications are provided.

Gives an overview of approaches and experiences on assessing ecological and human information on health risks.

Industrial applications are described, also addressing the need of risk assessments for SMEs. The needs of science and policy roles are described. Links to information sources, organisations, software models, EU legislation, and publications.

Industrial Water Quality

The classic guide to controlling industrial water pollution–updated with the latest regulations and new technologies

Turn to the Fourth Edition of Industrial Water Quality for guidance on state-of-the-art methods for optimizing or upgrading existing wastewater treatment systems, as well as selecting the best treatment options to solve specific wastewater problems. This hands-on tool reflects today’s more stringent water-quality regulations and the new technologies developed to meet them. Filled with examples and case studies from a variety of industries, the book covers reverse osmosis or alternative membrane processes and discusses Biological Nutrient Removal (BNR) processes.

HVAC Equations, Data, and Rules of Thumb, 2nd Ed.

The Latest Information and “Tricks of the Trade” for Achieving First-Rate HVAC Designs on Any Construction Job!

HVAC Equations, Data, and Rules of Thumb presents a wealth of state-of-the-art HVAC design information and guidance, ranging from air distribution to piping systems to plant equipment. This popular reference has now been fully updated to reflect the construction industry's new single body of codes and standards.

Featuring an outline format for ease of use, the Second Edition of this all-in-one sourcebook contains:

  • Updated HVAC codes and standards, including the 2006 International Building Code
  • Over 200 equations for everything from ductwork to air-handling systems
  • ASME and ASHRAE code specifications
  • Over 350 rules of thumb for cooling, heating, ventilation, and more
  • New material including: coverage of the new single body of construction codes now used throughout the country

Inside This Updated HVAC Design Guide

• Definitions • Equations • Rules of Thumb for Cooling, Heating, Infiltration, Ventilation, Humidification, People/Occupancy, Lighting, and Appliance/Equipment • Cooling Load Factors • Heating Load Factors • Design Conditions and Energy Conservation • HVAC System Selection Criteria • Air Distribution Systems • Piping Systems (General, Hydronic, Glycol, Steam, Steam Condensate, AC Condensate, Refrigerant) • Central Plant Equipment (Air-Handling Units, Chillers, Boilers, Cooling Towers, Heat Exchangers) • Auxiliary Equipment (Fans, Pumps, Motors, Controllers, Variable-Frequency Drives, Filters, Insulation, Fire Stopping) • Automatic Controls/Building Automation Systems • Equipment Schedules • Equipment Manufacturers • Building Construction Business Fundamentals • Architectural, Structural, and Electrical Information • Conversion Factors • Properties of Air and Water • Designer's Checklist • Professional Societies and Trade Organizations • References and Design Manuals • Cleanroom Criteria and Standards.


Dose Optimization In Drug Development

This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.


Intraocular Drug Delivery

This reference studies the most recent advances in the development of ocular drug delivery systems. Covering methods to treat or prevent ocular inflammation, retinal vascular disease, retinal degeneration, and proliferative eye disease, this source covers breakthroughs in the management of endophthalmitis, uveitis, diabetic macular edema, and age-related macular degeneration.


Drug Delivery to the Lung

This book focuses on the aerosol treatment of lung diseases, recent improvements in the understanding of proper dosage, and major innovations in device technology applied to clinical practice. Examines the behavior of inspired spherical particles in the respiratory tract! Featuring over 1300 references, drawings, tables, photographs, and micrographs, Drug Delivery to the Lung · outlines the history of inhaled medications in the treatment of respiratory disease · describes aspects of respiratory structure to inhalation therapy emphasizing developmental changes · compares existing in vitro/in vivo correlations for key aerosol modalities with lung model predictions · discusses particle diameter measurement, particle size statistics, and aerosol test methods · reviews the clinical effects of altering the deposition site of various classes of aerosolized drugs · surveys the development of novel, efficient, and convenient nebulizer systems · details breath-actuated and spacer devices constructed for children · analyzes dry-powder and pressurized metered dose inhalers · considers the transition from CFCs to new environmentally friendly chemical propellants · and more! Giving the clinician an overview of factors essential to understanding drug delivery via nebulization, Drug Delivery to the Lung is a superlative reference for pulmonologists; physiologists; pharmaceutical scientists; immunologists; allergists; analytical, organic, and medicinal chemists and biochemists; chemical, genetic, and process engineers; and medical and graduate school students in these disciplines.


Nanotechnology for Cancer Therapy

Encouraging communication between clinical investigators and nanoscientists, Nanotechnology for Cancer Therapy focuses specifically on effective and promising nanoscience and nanotechnology strategies for imaging and treating cancer. Among the various approaches considered, nanotechnology offers the best promise for the targeted delivery of drugs and genes to a tumor site and for alleviating side effects of chemotherapeutic agents. Renowned industrial and academic researchers describe the advantages of nanoparticles as sensing, delivery, image enhancement agents for cancer treatments, and various types of useful nanoparticles such as polymeric nanoparticles and dendrimers.


Nanoparticulate Drug Delivery Systems

Since the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery. This expertly written guide addresses the scientific methodologies, formulation, processing, applications, recent trends, and emerging technologies in the research of nanoparticulate drug delivery systems (NPDDS). It extensively covers applications of NPDDS, including lipid nanoparticles for dermal applications, nanocarriers for the treatment of restenosis, ocular, central nervous system, and gastrointestinal applications, and use as an adjuvant for vaccine development.


Pharmaceutical Experimental Design

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design · offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books · reviews screening designs for qualitative factors at different levels · presents designs for predictive models and their use in optimization · highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability · discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer · details nonstandard designs and mixtures · analyzes factorial, D-optimal design, and offline quality assurance techniques · reveals how one experimental design evolves from another · and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.


Troubleshooting LC Systems: A Comprehensive Approach to Troubleshooting LC Equipment and Separations

Major advances in instrumentation and technology have made high-performance liquid chromatography (HPLC) a pervasive tool in virtually all areas of chemical and biomedical research today. Despite HPLC's enormous growth, technical problems still bedevil most users at least occasionally.

Based on their immensely successful short courses, Dolan and Snyder's landmark new book --Troubleshooting LC Systems--now makes available to every practicing chromatographer the authors' wealth of expertise from years of hands-on troubleshooting of real-world LC problems--problems that routinely cause crises and unproductive downtime in nearly every lab.

Believing that successful troubleshooting requires an understanding of the basics, Dolan and Snyder open by setting forth all the fundamental principles of LC operation, then move on to a microscopic description of all the elements of LC devices, to lay out their optimal preventive maintenance routines, and ultimately to offer an unprecedentedly thorough treatment of each and every facet of troubleshooting.

Displaying a special tutorial mastery--honed to a fineness during their ongoing teaching and consulting activities, and a well-received feature column in LC Magazine--the book's chapters cover: automation and robotics • approaches to troubleshooting • reactions of samples • basic separation techniques • valves, tubing, syringes • band broadening and tailing • preventive maintenance • column packing and flushing • individual LC modules • troubleshooting principles • reagents and buffering • specific problems in separation • ghost and vacancy peaks • quantitation and calibration • pumps, seals, and pistons • gradient elution problems • column composition • concentration and blockages • sample cleanup • temperature and mixing effects • detectors and recorders • column packing and flushing.

In short, Dolan and Snyder's eminently practical new guide to Troubleshooting LC Systems is an essential laboratory handbook--one that empowers expert and novice chromatographer alike to solve every sort of practical laboratory problem on a day-to-day basis. No one using an LC system should be without it!


Analytical Instrumentation: Performance Characteristics and Quality

There is an increasing need for analysts to understand and be able to quantify the performance of analytical instruments, in particular with respect to the following:

* specifying equipment for purchase
* estimating uncertainties in intrumental measurements
* quantifying and demonstrating performance quality

This text links together an understanding of performance characteristics with an appreciation of the limitations imposed by instrument design, leading to the interplay of the validation and qualification processes within quality assurance systems.
A unique framework of topics covers the major instrumental techniques of spectrophotometry, chromatography, capillary electrophoresis, and atomic emission spectroscopy. The use of over 200 questions and answers, together with cross-referencing, helps to develop a thorough understanding of the various concepts that underpin the different techniques.
This book will appeal to a broad range of professional chemists, technicians and students, weither with reference to specific analytical techniques, or within a general course of study in instrumental performance. Analytical Techniques in the Sciences-This series of books provides coverage of all the major analytical techniques and their application in the most important areas of physical, life and materials sciences. Each text is presented in an open learning/distant learning style, in which the learning objectives are clearly identified. The reader's understanding of the material is constantly evaluated by the use of self-assessment and discussion questions.


Modern Practice of Gas Chromatography

The bible of gas chromatography-offering everything the professional and the novice need to know about running, maintaining, and interpreting the results from GC Analytical chemists, technicians, and scientists in allied disciplines have come to regard Modern Practice of Gas Chomatography as the standard reference in gas chromatography. In addition to serving as an invaluable reference for the experienced practitioner, this bestselling work provides the beginner with a solid understanding of gas chromatographic theory and basic techniques.
This new Fourth Edition incorporates the most recent developments in the field, including entirely new chapters on gas chromatography/mass spectrometry (GC/MS); optimization of separations and computer assistance; high speed or fast gas chromatography; mobile phase requirements: gas system requirements and sample preparation techniques; qualitative and quantitative analysis by GC; updated information on detectors; validation and QA/QC of chromatographic methods; and useful hints for good gas chromatography.
As in previous editions, contributing authors have been chosen for their expertise and active participation in their respective areas. Modern Practice of Gas Chromatography, Fourth Edition presents a well-rounded and comprehensive overview of the current state of this important technology, providing a practical reference that will greatly appeal to both experienced chomatographers and novices.


Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include paper- and peopleless plants, GxP compliance, integrating manufacturing systems, electronic signatures, validating asset management systems, enterprise/manufacturing planning systems, lab information management systems, and Local & Wide Area Networks, compliance for IT Infrastructure, IT system maintenance and support, and auditing suppliers, software Integrators, and hardware manufacturers.


Validating Medical Packaging

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.


Validated Cleaning Technologies for Pharmaceutical Manufacturing

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.