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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general prose style that makes it useful to both students and professionals.

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Introduction to Modern Liquid Chromatography-2 Ed.

This Second Edition incorporates the latest developments in the practical application of LC. Covers the basic of LC, the six LC methods and their applications, and various specialized areas. Provides material for in-depth comprehension of how HPLC is performed, what the necessary materials are, and possible applications. Offers thorough treatment of such areas as quantitative and qualitative analysis by HPLC, preparative scale separations, gradient elution and column-switching, sample pretreatment and reaction detectors, automated systems for high-volume testing and/or samples requiring pretreatment, troubleshooting and sample artifacts, and selection and development of LC method for a particular applications.

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HVAC Systems Design Handbook, 4th edition

The third edition of this practical, hands-on reference is revised and updated to provide HVAC professionals with complete guidance on the design of effective, efficient HVAC systems. Packed with over 300 clear illustrations and tables, the book reflects the latest technological and procedural developments in HVAC systems and components for residential, commercial, and industrial buildings. Readers will find details on the new refrigerants now being used in HVAC equipment--information of new concerns related to indoor air quality--and numerous applications and on-the-job insights that will be helpful in the successful design, operation, and maintenance of peak-performing systems.

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Hvac Fundamentals

This master volume covers the full range of HVAC systems used in today's facilities. Comprehensive in scope, the text is intended to provide the reader with a clear understanding of how HVAC systems operate, as well as how to select the right system and system components to achieve optimum performance and efficiency for a particular application.

You'll learn the specific ways in which each system, subsystem or component contributes to providing the desired indoor environment, as well as what factors have an impact on energy conservation, indoor air quality and cost. Examined in detail are compressors, water chillers, fans and fan drives, air distribution and variable air volume, pumps and water distribution, controls and their components, heat recovery, and energy conservation strategies. Also covered are heat flow fundamentals, as well as heat flow calculations used in selecting equipment and determining system operating performance and costs. 300 pp.

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Fundamentals of HVAC Systems

Heating, Ventilation and Air-Conditioning (HVAC)systems are omnipresent in modern buildings. This book is an introduction for all those involved in the specification, design, manufacture, installation, operation or maintainance of these systems.

Developed jointly with the ASHRAE Learning Institute, the leading and recognised technical experts in the industry. This Inch-Pound edition is primarily for use in US markets. An SI version is also available on ISBN 0123739985.

The book explains:
The objectives to be achieved by a system in terms of environmental control.
The description of a system - including primary equipment, means of distribution, space and load determination, and operating strategy.
The basic function of components that form HVAC systems.
The layout and functioning of common HVAC systems, including all-air systems, air-water systems, and all-water systems.
The strategies for operating systems and their basic means of control.
Identifying the most suitable type of system for different types of application

* Air-conditioning is a major industry and growing. Shows how systems operate and how to select, design and operate them efficiently to minimise installation cost and ongoing energy cost
* Endorsed by, and developed with ASHRAE, the leading trade body and recognised technical experts
* Provides a thorough introduction to how HVAC systems function in controlling temperature, air quality, and air circulation in a controlled space.

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Fundamentals of Analytical Chemistry (with CD-ROM and InfoTrac )

FUNDAMENTALS OF ANALYTICAL CHEMISTRY, EIGHTH EDITION is known for its readability combined with a systematic, rigorous approach that characterizes this classic text. Extensive coverage of the principles and practices of quantitative chemistry ensures suitability for chemistry majors. These award-winning authors include applications throughout industry, medicine, and all the sciences. The text's new design and wealth of new photographs by renowned chemistry photographer Charlie Winters serve to reinforce student learning through dynamic visuals. Reflecting the increased emphasis of spreadsheets as a tool in analytical chemistry, this new edition adds an additional chapter, new problems and a new supplement, EXCEL® APPLICATIONS FOR ANALYTICAL CHEMISTRY, that integrate this important aspect of the study of analytical chemistry into its already rich pedagogy. In addition, the INTERACTIVE ANALYTICAL CHEMISTRY CD-ROM, packaged FREE with every new text, enhances conceptual understanding through hands-on integrated multimedia interactivity.

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Profiles of Drug Substances, Excipients and Related Methodology, Volume 33

Whilst following in the footsteps of previous volumes by presenting comprehensive reviews of drug substances and additional materials, this title also heralds a significant expansion of the scope of the series. Traditional contributions will now also be augmented by publication of critical review chapters that summarize information related to the characterization of drug substances and excipients. This change is required to better meet the needs of the pharmaceutical communtiy and to allow the development of a timely vehicle for publishing review materials on this topic.

The scope of the Profiles series will encompass review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

* Presents comprehensive reviews covering all aspects of drug development and formulation of drugs
* Now encompassing critical review chapters
* Meets the information needs of the drug development community

Drug Delivery to the Oral Cavity

With contributions from recognized authorities in industry, academia, and government, this reference presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market.

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CRC Handbook of Optical Resolutions via Diastereomeric Salt Formation

This handbook has the following distinctions:

• The importance of resolvability (Fogassy’s parameter), which permits the direct comparison of the efficiencies of independent resolution procedures, is emphasized, and its definition is thoroughly explained throughout the text.
• There are clear explanations of the mechanism and kinetics, including the equilibria between a racemate and a resolving agent in a solution and between a solution and a crystal not only for resolutions using an equimolar amount of resolving agents, but also for resolutions employing half the amount of resolving agent and for resolutions under immiscible two-liquid-phase conditions with concrete examples.
• There are very valuable lists of commonly used acidic and basic resolving agents (50 of each), along with their physical data, CA number, and catalog numbers.
• Structural modification of a resolving agent and the correlation between the resolvability and the structures of a racemate and a resolving agent are exemplified.
• The definite methods for the selection of a suitable resolving agent for a given racemate are presented.
• There are explanations on the optimization of parameters (solvent, initial concentration, and temperature), initiation of crystallization, separation of crystals/liquid, improvement of the optical purity of the first-generation salt, recovery of components, and enantiomeric enhancement.
• Several modified methods for optical resolution by diastereomeric salt formation are presented with definite examples.
• There are short summaries of 4000 resolutions by diastereomeric salt formations; these are invaluable for researchers and others who want to resolve an unknown racemate.

Thus, this handbook serves as a companion book for researchers, engineers, and graduates who are working on or who intend to work on the optical resolution of racemates by diastereomeric salt formation. In addition, this handbook will contribute significantly to further progress in the field of optical resolution of racemates by diastereomeric salt formation.

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Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition

This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. Using current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently. Chapters include: Overview of Clinical Research, FDA Regulations and Good Clinical Practice Guidelines, The Study: Planning Stages and Commencement, Interactions with the Sponsor, Interactions Within the Institution; The Role of the Study Subjects, Data Management: Adverse Events, Investigational Agent Management, and Inspection of Clinical Research Sites.

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CRC Handbook of Laboratory Safety, Fifth Edition

Expanded and updated, The CRC Handbook of Laboratory Safety, Fifth Edition provides information on planning and building a facility, developing an organization infrastructure, planning for emergencies and contingencies, choosing the correct equipment, developing operational plans, and meeting regulatory requirements. Still the essential reference tool, the New Edition helps you organize your safety efforts to adhere to the latest regulations and use the newest technology. Thoroughly revised, the CRC Handbook of Laboratory Safety, Fifth Edition includes new OSHA laboratory safety standards, the 1994 NRC radiation safety standards, guidelines for X-ray use in hospitals, enforcement of standards for dealing with blood-borne pathogens, OSHA actions covering hazardous waste operations and emergency response, and the latest CDC guidelines for research with microbial hazards. Every word on every page has been scrutinized, and literally hundreds of changes have been made to bring the material up to date. See what's new in the New Edition o New figures and tables illustrating the new material o Internet references in addition to journal articles o Changes in the Clean Air Act regarding incineration of hospital, medical, and infectious waste o Obsolete articles removed and replaced - over one hundred pages of new material o New information on respiratory protection guidelines.

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Generic Drug Development: Solid Oral Dosage Forms

Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.

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Fate of Pharmaceuticals in the Environment and in Water Treatment Systems

Leading experts cover critical issues regarding the occurrence, persistence, treatment, and transformations of pharmaceuticals in the environment and in water treatment systems. Topics range from field studies documenting the occurrence of pharmaceuticals in environmental compartments, to laboratory studies determining the degradation kinetics and formation of by-products during treatment. The text provides data to help scientists, regulators, and engineers understand the factors that affect the environmental fate of pharmaceuticals in soil and water, to facilitate the development of best management practices, and optimize treatment systems for removal of these compounds from the environment.

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Vogel's Textbook of Quantitative Chemical Analysis, 5th edition

This book is a standard in the field of analytical chemistry, especially wet chemistry. It is not intended to be a textbook for a quant course, unlike Dan Harris's Quantitative Chemical Analysis or Doug Skoog's Fundamentals of Analytical Chemistry, which are both excellent college texts. However, it is an outstanding ready-reference for chemists and chemistry graduate students. It is the authority for all sorts of chemical analyses, and it gives concise, complete background along with exact procedures, including problems likely to be encountered, precautions to be taken, or deficiencies of the method. It is well-indexed and quite complete is breadth and scope.

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HPLC Methods for Pharmaceutical Analysis, Volume 1

Lets you target the specific information you need quickly and easily -so you can stay in the lab and out of the library. This invaluable database -available in print and electronic form -gives you fast, hands-on access to the most significant literature available on HPLC for the analysis of over 150 of the most frequently prescribed pharmaceutical compounds. Combining full descriptions of procedures with specially annotated references, HPLC Methods for Pharmaceutical Analysis helps you to identify the techniques that are relevant to your individual project needs -eliminating hours of tedious, time-consuming library research. Analytical chemists and researchers will find a battery of useful features that make this practical new resource a welcome addition to their reference library: Techniques for each compound are described in detail -enabling replication of a procedure without reference to the original publication
* Detailed procedures for each drug are listed together -making it easy to combine features of different methods into a customized approach
* Drug assay methods are provided for drugs in biological fluids such as blood or urine, as well as for bulk and formulated drugs
* Other key information includes chemical structures, molecular weights and formulas, CAS Registry Numbers, and cross-references to The Merck Index and Chemistry of Drug Synthesis


Pharmaceutical Product Development: In Vitro-In Vivo Correlation

Lets you target the specific information you need quickly and easily -so you can stay in the lab and out of the library.

This invaluable database -available in print and electronic form -gives you fast, hands-on access to the most significant literature available on HPLC for the analysis of over 150 of the most frequently prescribed pharmaceutical compounds. Combining full descriptions of procedures with specially annotated references, HPLC Methods for Pharmaceutical Analysis helps you to identify the techniques that are relevant to your individual project needs -eliminating hours of tedious, time-consuming library research. Analytical chemists and researchers will find a battery of useful features that make this practical new resource a welcome addition to their reference library: Techniques for each compound are described in detail -enabling replication of a procedure without reference to the original publication

* Detailed procedures for each drug are listed together -making it easy to combine features of different methods into a customized approach
* Drug assay methods are provided for drugs in biological fluids such as blood or urine, as well as for bulk and formulated drugs
* Other key information includes chemical structures, molecular weights and formulas, CAS Registry Numbers, and cross-references to The Merck Index and Chemistry of Drug Synthesis

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New Vaccine Development: Establishing Priorities

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Volume - II:

Pharmaceutical Manufacturing Encyclopedia, 3rd Edition

This industry standard encyclopedia on pharmaceutical manufacturing processes has been completely updated in this 3rd Edition with FDA approved drugs up to the summer of 2004. This four volume set gives details for the manufacture of 2,226 pharmaceuticals that are being marketed as a trade-named product somewhere in the world. Each entry includes:

Theraputic Function
Chemical and Common Name
Structural Formula
Chemical Abstracts Number
Trade Name, Manufacturer, Country, and Year Introduced
Raw Materials
Manufacturing Process

In addition, references are also cited to major pharmaceutical works where additional information can be obtained on synthesis and the pharmacology of the individual products.

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Pharmaceutical Dosage Forms-volume 2

This outstanding Second Edition of an indispensable reference text concentrates on specific types of disperse system dosage forms, including methods of formulation and stability test procedures.

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Encyclopedia of Controlled Drug Delivery, 2 Volume Set

Covers all aspects of controlled drug delivery, including human, agricultural and animal applications. The 70 entries, written by an international team of renowned experts, offers A-to-Z coverage of controlled drug delivery systems for researchers in the pharmaceutical and biotechnology industries, agriculture companies, medical device companies, clinical research organizations and medical schools.

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Analysis of Cosmetic Products

Analysis of Cosmetic Products advises the reader from an analytical chemistry perspective on the choice of suitable analytical methods for production monitoring and quality control of cosmetic products. In the format of an easy-to-understand compendium of published literature on the subject, this book will enable people working in the cosmetic industry or in research laboratories to:

* become familiar with the main legislative and analytical literature on this subject and
* learn about and choose suitable analytical procedures for production monitoring and control of cosmetic products, according to their composition.

The first section of Analysis of Cosmetic Products covers various definitions and concepts relating to cosmetic products, current legislation in different countries and specific legislation on ingredients. The central body of the book addresses analytical methods for monitoring and quality control of cosmetic products with the fundamental objective being to enable reader's access to scientific reviews carried out by experts in analytical chemistry. The final section contains a small review of the alternative methods to using animals for cosmetic product evaluation.
* An essential resource for those in the cosmetic industry and research laboratories, allowing you to become familiar with the main analytical literature
* Up-to-date and exhaustive overviews of current knowledge dealing with cosmetic analysis, general concepts and legislation
* Including tables and figures, designed to graphically communicate important information in an easy-to-understand format

Validation of Toxicogenomic Technologies

Toxicogenomics has been described as a discipline combining ex-pertise in toxicology, genetics, molecular biology, and environmental health to elucidate the response of living organisms to stressful environ-ments. It includes the study of how genomes respond to toxicant expo-sures and how genotype affects responses to toxicant exposures. As the technologies for monitoring these responses rapidly develop, it is critical that scientists and regulators are confident that the technologies are reliable and reproducible and that the data analyses have been validated. To discuss these issues in a public forum, the Committee on the Validation of Toxicogenomic Technologies designed a workshop to consider the current practice and advances in the validation of toxicogenomic tech-nologies. The workshop focused on the technical aspects of validation, recognizing it as a prerequisite for considering other important issues, such as biological validation (e.g., validating the use of microarray “sig-natures” to describe a toxic effect).

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Fiedler Encyclopedia of Excipients: For Pharmaceuticals, Cosmetics and Related Areas

The two-volume encyclopedia offers a detailed description of properties, analyses and characteristic data for more than 17,000 excipients used in the manufacture of pharmaceuticals, cosmetics and related products. In addition, pharmacological and toxicological properties as well as allergy-inducing reactions are evaluated. Information on manufacturers is given in a directory at the end of the second volume.


Good Manufacturing Practices and Inspection (Quality Assurance of Pharmaceuticals)

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control, and in the pharmaceutical industry.


Raman Spectroscopy for Chemical Analysis

Owing to its unique combination of high information content and ease of use, Raman spectroscopy, which uses different vibrational energy levels to excite molecules (as opposed to light spectra), has attracted much attention over the past fifteen years. This book covers all aspects of modern Raman spectroscopy, including its growing use in both the laboratory and industrial analysis.

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ISO 14001 - The World's EMS Standard [Vedio]

A Concise Introduction to the ISO 14001 Environmental Management System standard...ISO 14001 environment environmental management standard


Pharmaceutical Dosage Forms: Disperse Systems, Volume 3

This third volume of the second edition offers information on specialized products such as emulsions, liposomes, polymers and polymeric pharmaceutical excipients. It explains the requirements for conducting clinical research and obtaining marketing approval for new drug products.

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Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation

Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. It offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute manufacturing APIs.

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Advanced Drug Formulation Design to Optimize Therapeutic Outcomes

This title demonstrates how advanced formulation designs and delivery technologies can be used to improve drug efficacy and treatment outcomes in particular therapeutic categories or disease states. It discusses nanoparticle systems for cancer treatments, and also presents cutting edge immono-regulation agents for transplantation and the local targeting of drugs, especially poorly water soluble drugs to provide enhanced therapeutic outcomes. In addition, this title highlights areas of therapy showing the most promise for improvement in clinical outcomes via advanced formulation design.

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Analytical Profiles of Drug Substances and Excipients, Volume 29 (APDSE)

Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Analytical Profiles of Drug Substances and Excipients, brings the latest information together in one source.

· Represents a very important contribution to the practice of pharmaceutical analysis
· Presents an excellent overview of physical, chemical, and biomedical properties of some regularly prescribed drugs
· Each volume in the series contains a cumulative index

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Risk-sharing in the Pharmaceutical Industry: The Case of Out-licensing (Contributions to Management Science)

The costs of developing a new drug have reached record levels in the pharmaceutical industry. As any failure of a new drug candidate can lead to significant losses, many pharmaceutical companies are looking for new approaches to reduce their exposure to R and D risks. In this context, the book deals with the topic of out-licensing as a novel form of risk-sharing collaborations. The phenomenon of out-licensing is illustrated by three major case studies of Novartis, Schering and Roche as well as several smaller case studies. In addition, the Noble Prize awarded economic theory of Adverse Selection is applied to analyze the topic theoretically. The gained insights allow identifying the critical parameters of out-licensing collaborations and thereby provide R and D managers with recommendations on how to conclude and manage this type of deals more effectively.

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Optimizing the "Drug-Like" Properties of Leads in Drug Discovery

Traditionally, incorporating optimal drug-like properties into a structural lead was not considered by medicinal chemists to be their responsibility. Instead, medicinal chemists felt that the undesirable drug-like properties in their drug candidates would be fixed by preclinical development scientists. However, that view has changed in the past 510 years, resulting in another significant paradigm shift in drug discovery. The most significant aspect of this latest paradigm shift is the recognition by medicinal chemists that the drug-like properties of structural hits, structural leads, and drug candidates are intrinsic properties of the molecules and that it is the responsibility of the medicinal chemist to optimize not only the pharmacological properties but also the drug-like properties of these molecules. Therefore, assessment of these drug-like properties is now done early in the drug discovery process on structural hits and structural leads as well as the design of screening libraries. Optimization of these drug-like properties is done through an iterative process in close collaboration with preclinical development scientists. This process is analogous to the process used by the medicinal chemist to characterize and optimize the pharmacological activity of their structural hits, leads and drug candidates.

Recognizing these changes in the paradigm by which drugs are discovered, the American Association of Pharmaceutical Scientists (AAPS) has recently organized and sponsored two focused workshops in the area of profiling drug-like properties during drug discovery.

The first workshop, entitled "Pharmaceutical Profiling in Drug Discovery for Lead Selection", took place in Whippany, NJ on May 19-21, 2003. This workshop, which was co-sponsored by the American Chemical Society-Medicinal Chemistry Division and the Society for Biomolecular Screening, was focused on prediction, measurement, and utilization of drug-like properties during lead selection. From this workshop arose the book entitled Pharmaceutical Profiling in Drug discovery for Lead Selection, which was edited by Ronald T. Borchardt, Edward H. Kerns, Christopher A. Lipinski, Dhiren R. Thakker and Binghe Wang and published by AAPS Press (Arlington, VA) in 2004.

The second workshop entitled "Optimizing the Drug-Like Properties of Leads in Drug Discovery" took place in Parsippany, NJ on September 19-22, 2004. This workshop, which was co-sponsored by the American Chemical Society-Medicinal Chemistry Division, American Chemical Society-North Jersey Section, American Society for Clinical Pharmacology and Therapeutics, European Federation for Pharmaceutical Sciences, International Society for the study of Xenobiotics, and the Society of Toxicology, was focused on the optimization of the drug-like properties of leads in drug discovery. If the strategies and the methodologies presented at this workshop were to be adopted by pharmaceutical and biotechnology companies, it is the belief of the workshops organizers that more higher quality drug candidates would be advancing into preclinical and clinical development resulting in more efficacious and safer drugs.

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Nanoparticulates As Drug Carriers

Written by key experts in the field of nanomedicine, this book provides a broad introduction to the important field of nanomedicine and application of nanotechnology for drug delivery. It covers up-to-date information regarding various nanoparticulate drug delivery systems, describes the various opportunities for the application of nanoparticular drug carriers in different areas of clinical medicine, and analyzes already available information on their clinical applications. This book can be used as an advanced textbook by graduate students and young scientists and clinicians at the early stages of their career. It is also suitable for non-experts from related areas of chemistry, biochemistry, molecular biology, biomedical engineering, physiology, experimental and clinical medicine, and pharmaceutical sciences, who are interested in general problems of drug delivery and drug targeting, as well as in more specialized topics of using nanoparticulate-mediated drug delivery approaches in the individual areas of clinical medicine. Prof Torchilin is an expert in Nanomedicine and a recipient of numerous awards including the Lenin Prize in Science Technology of the former USSR, membership in the European Academy of Sciences, and AAPS Research Achievement Award in Pharmaceutics and Drug Delivery. He served as an Associate Professor of Radiology at Harvard Medical School before joining Northeastern University as the Chairman of the Department of Pharmaceutical Sciences.

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