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Pharmaceutical Suspensions: From Formulation Development to Manufacturing

The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues to be a challenge on many fronts.

A good understanding of fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical active dispersed in a suitable vehicle.

After discussing various disperse systems, the theory of disperse systems and commonly used excipients, the remaining chapters in this textbook systematically detail the development of pharmaceutical suspensions, from pre-formulation stage to clinical development, regulatory submission and commercial manufacturing. Additionally, the emerging area of nano-suspensions as applied to pharmaceutical filed is also discussed. Each of the chapters in Pharmaceutical Suspensions was written independently by scientists skilled in their specific areas. Contributing authors represent a cross-sections of scholars from Academic Institutions, Pharmaceutical Industries and Regulatory Agency.


Cell Therapy: cGMP Facilities and Manufacturing

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.

Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…

Standard operating procedures
Supply management
Facility equipment
Product manufacturing, review, release and administration
Facility master file


Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories

Offers guidance for the implementation of a quality management system in drug testing laboratories: a commitment to quality and continuous improvement.
The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.


Handbook of Pharmaceutical Excipients, 6th Edition

"The Handbook of Pharmaceutical Excipients" is internationally recognised as the authoritative source of information on pharmaceutical excipients. "The Handbook of Pharmaceutical Excipients" is a comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential reference for those involved in the development, production, control or regulation of pharmaceutical preparations. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity. All monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.

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Martindale: The Complete Drug Reference, 36th Edition

This book provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale" contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust "Martindale".

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Wilson & Gisvold's Textbook of Organic Medicinal and Pharmaceutical Chemistry 11th Ed.

Oregon State Univ., Corvallis. Blends the chemical and pharmaceutical principles necessary for understanding structure-activity relationships and molecular mechanisms of drug action. Offers new information on emerging trends and advances and the challenges posed by new diseases. Features a new chapter on combinatorial chemistry.

USP NF 2009 (United States Pharmacopeia 32 / National Formulary 27)

The United States Pharmacopeia–National Formulary and its Supplements become official six months after being released to the public. The USP–NF, which is released on November 1 of each year, becomes official on May 1 of the following year.

This change was adopted to give users more time to bring their methods and procedures into compliance with new and revised USP–NF requirements.

The table below describes the new official dates. The 2008 USP31–NF26, and the Supplements and Interim Revision Announcements (IRAs) to that edition, will be official until May 1, 2009, at which time the USP32–NF27 becomes official.

Pharmaceutical Microbiology

The textbook on `Pharmaceutical Microbiology` has been adequately developed and expanded according to the AICTE- Approved Syllabus-2000 meant for the Pharmacy Degree Programme across all the Indian Universities, and others abroad offering similar curricula.

Specific attention has been duly paid to the presentation of each chapter that essentially includes: brief introduction, theoretical aspects, classification, neat and vivid diagrammatic illustrations of figures-graphics-equipments, lucid explanations, supportive classical examples, and profusely supplemented with explanatory`foot notes`-references in addition to further reading bibliography.

The text content runs over ten chapters that may prove to be of paramount interest and enormous readability not only confined to the B.Pharm., students but also to various M.Sc., academic curricula in such disciplines as: Food Microbiology, Environmental Science, Microbiology etc.

Key Features IncludeConcise and exhaustive presentation of scientific informations from several sources.A wealth of theoretical information that opens newer possibilities.Detailed classification of various microbial aspects.Pharmaceutical assays and methodologies.Comprehensive index includes significant terminologies.Well documented statement of facts.


Non-Prescription Medicines 2nd Edition

This revised edition assesses the range of non-prescription, over-the-counter medicines that can be recommended for the most frequently encountered minor illnesses. The first edition has been updated to reflect changes in the legal status and availability of products and new opinions on and approaches to treatment. A new section on emergency hormonal contraception is also included. The information is presented in a structured formulary format with products described both generically and by brand name along with supplier details. Each chapter also contains a summary of key points with suggestions regarding the most appropriate products. The book should enable pharmacists, GPs, nurses and other healthcare professionals to make well-informed recommendations and to give patients and customers sound advice on non-prescription medicines.

Drug-Drug Interactions: Scientific and Regulatory Perspectives, Volume 43 (Advances in Pharmacology)

Drug–Drug Interactions is a comprehensive review of the scientific and regulatory perspectives of drug–drug interactions from the point-of-view of academia, industry, and government regulatory agencies. This book is intended for professionals in the pharmaceutical industry, health care, and governmental regulatory agencies. Topics of interest include the mechanistic understanding of drug–drug interactions, the prediction of drug–drug interaction potential of new drugs, and the avoidance of clinically significant drug–drug interaction in patients.

Key Features

* Provides useful references on the science of drug-drug interactions
* Describes in a basic and comprehensive manner drug-drug interactions from the mechanistic viewpoint
* Contains original data from academic and industrial laboratories
* Presents an overview of regulatory agency positions

Pharmaceutical Drug Analysis

During the past two decades, there have been magnificent and significant advances in both analytical instrumentation and computerized data handling devices across the globe. In this specific context the remarkable proliferation of windows-based computer software stretched overwhelmingly towards instrument control, real time data handling abilities and the ultimate usage of Laboratory Information Management Systems (LIMS) are surprisingly noteworthy.

Pharmaceutical Drug Analysis in its present form essentially comprises six parts containing in all 32 well-elaborated chapters predominantly dealing with the set of descriptive analytical methodologies developed to control and assure the quality of the final marketed product; and, therefore, includes both qualitative and quantitative methods of analysis to help in the identification as well as purity of the product.

The main purpose of this textbook is to discuss in an explicit and lucid manner several of the newer methods that now find rather wider application in the domain of pharmaceutical analysis. The basic principle of each technique is critically treated with emphasis on factors that directly affect its proper and judicious application to various analytical problems. An in-depth knowledge of these principles, instrumentations, modus operandi, experimental parameters, and sample preparation procedures in order to optimize the performance procedure of typical assay of pharmaceutical secondary products i.e., dosage forms, calculations etc., along with cognate assays from the Official Compendia have been included profusely.

Undergraduate and postgraduate students of pharmaceutical drug analysis, quality assurance chemists, industrial trainees, bulk-drug professionals and those in related disciplines earnestly requiring a substantial fundamental understanding and knowledge of the subject will certainly find this a much needed suitable compilation for reading and reference.

The broad coverage included in each of the selected analytical techniques would render Pharmaceutical Drug Analysis to be an useful source of ideas, inspiration for research, and developing newer practical solutions to problems in the ever expanding field of pharmaceutical analysis.

Pharmacy Student Survival Guide

The book every pharmacy student must own!

Pharmacy Student Survival Guide is a one-of-a-kind roadmap for excelling in pharmacy practice courses. A combination calculations, kinetics, drug information, medical terminology, and laboratory data book all in one, the Guide helps you organize case information, improve problem-solving skills, learn terminology, and impress faculty during rounds.

Pharmacy Student Survival Guide is presented in three sections that span the entire pharmacy curriculum:

Systems and Expectations covering ethics, communication, monitoring drug therapy, and regulatory agencies, Patient Care Tool Box covering medical terminology, pharmacokinetics, laboratory data, and physical assessment, Topics in Pharmacy Practice covering Drug Information and Drug Literature Evaluation, Community/Ambulatory Care, Institutional Pharmacy Practice, Public Health, Reducing Health Disparities Through Domestic and Global Outreach to the Undeserved, Valuable for both introductory and advanced practice course, Pharmacy Student Survival Guide is a book you will turn to throughout your entire pharmacy education.

Basic Pharmacokinetics

This is the essential guide to the study of absorption, distribution, metabolism and elimination of drugs in the body. Pharmacokinetics and biopharmaceutics courses have been included in pharmacy curricula in the USA and Europe for several years. Pharmacokinetics is the study of absorption, distribution, metabolism and elimination of drugs in the body. Pharmacists must understand this to ensure appropriate drug regimen for patients. The scope and the intent of this textbook is to provide the reader with a basic intuitive understanding of the principles of pharmacokinetics and biopharmaceutics and how these principles, along with the equations presented in each chapter, can be applied to achieve successful drug therapy. The application of pharmacokinetics principles and equations are illustrated by providing the reader with data available in the literature. As pharmacokinetics is basically mathematical in nature, a chapter has been included to provide the reader with a basic review of the mathematical principles and graphing techniques necessary to understand pharmacokinetics. At the start of each chapter, important objectives are listed to accentuate and identify the key points of the chapter. When an important and clinically applicable equation appears in the text, a paragraph will follow explaining the significance and therapeutic applications of that equation. Additionally, this paragraph includes and explains relevant factors influencing parameters in an equation. When applicable, at the end of an important equation, a general profile illustrating the relationship between the two variables of an equation will be presented. This approach should make the subject matter much more accessible to the student. Each chapter concludes with related problem sets and problem solving exercises for the student to work through. This should enable the reader to become more adept at solving pharmacokinetic problems arising in drug therapy and understanding the applications and utility of equations in clinical pharmacokinetics and practice. As you can see from the contents, the book is organised into eighteen chapters, the first consists of mathematical principles necessary to understand pharmacokinetics and an overview of the subject matter. The remaining chapters are organised in an order which should be easy for the reader to follow. Clearance and other essential fundamental pharmacokinetic parameters are introduced early in the book as the student will need to apply these concepts in subsequent chapters. A uniform set of notation will be adopted throughout the textbook (a table of which will be at start of the book).

MCQs in Pharmaceutical Calculations

This is a revision guide in calculations for pharmacy students and registration trainees. This text is part of the RPS "Tomorrow's Pharmacist" series. The pharmaceutical societies of Great Britain and Northern Ireland (RPSGB and PSNI) have introduced compulsory calculations elements into the registration examinations. These sections must be passed independently of the rest of the examination with a mark of 70 per cent. The authors of this text actually set the calculation questions for the PSNI preregistration exam and are therefore aware of the standards required and the type of questions asked; making this an essential revision textbook for students taking this exam. This text is part of the RPS "Tomorrow's Pharmacist" series following the same style/design as these texts, which are all aimed at graduating students and preregistration trainees (titles currently include: "Registration Exam Questions", "The Preregistration Interview" and "Hospital Preregistration Training").

Modern Pharmaceutics, Fifth Edition, Volume 2: Applications and Advances

Volume 2 discusses the applications and approaches in advanced drug delivery systems, including transdermal, pulmonary, and ocular routes. In addition, it describes the impact of the shift to personalized medicines in the fields of pharmaceutical biotechnology, pharmacogenomics, and nanotechnology.

DELIVERY OF DRUGS BY THE PULMONARY ROUTE - Covers the interaction between the physical chemistry of the formulations and administered particles with the anatomy of the bronchial and alveolar regions

PEDIATRIC AND GERIATRIC PHARMACEUTICS - Addresses the physiological changes, design, and production of formulations for each of these patient populations

BIOEQUIVALENCE EVALUATION - Covers how to measure the bioequivalence of the same drug in quick-release tablet, capsule, or sustained-release form, as well as branded and generic systems

TARGET-ORIENTED DELIVERY SYSTEMS - Explores the challenges of designing delivery systems that target specific sites in the body and cause fewer side effects through interaction with non-diseased tissues.

Solving Problems in Food Engineering

* Allows those with little or no background in engineering to grapple with food engineering problems
* Includes supplemental text that covers the basics of food engineering problem solving
* Carefully graded practice problems progress from easy to complex

Solving Problems in Food Engineering is a step by step workbook intended to enhance students' understanding of complicated concepts and to help them practice solving food engineering problems. The book covers problems in fluid flow, heat transfer, mass transfer, and the most common unit operations that have applications in food processing, such as thermal processing, cooling and freezing, evaporation, psychrometrics and drying. Included are theoretical questions in the form of true or false, solved problems, semi-solved problems, and problems solved using a computer. The semi-solved problems guide students through the solution. Some of the problems progress from elementary level increasing difficulty so that the book is useful to food science as well as food engineering students.

Control Systems for Heating, Ventilating, and Air Conditioning

Control Systems for Heating, Ventilating and Air Conditioning, Sixth Edition contains a comprehensive treatment of heating and air conditioning system controls. This book was originally written to provide fundamentals of HVAC control to practitioners who were designing new control systems or maintaining existing control systems. Emphasis on fundamental control system principles along with the psychrometrics of air conditioning processes has remained a focus of the new edition. While control system technology has changed drastically over the years, the fundamentals of controlling heating and air conditioning systems have changed only modestly.

Readers will find that fundamentals of existing control systems remain in this book so that those who need to maintain or troubleshoot systems that are twenty or thirty years old will be able to see what practitioners did during that time frame. In addition the ubiquitous application of digital control technology in very recent times is also described. Note that the fundamental control principles once implemented pneumatically are now being implemented in modern digital computers - software now replaces hardware. Another change since the last addition is a new emphasis on controlling minimum fresh air for validation purposes. New techniques for doing this have been developed in response to ASHRAE Standard 62, "Ventilation for Acceptable Indoor Air Quality," and these methods are included.

Control Systems for Heating, Ventilating and Air Conditioning, Sixth Edition is complete and covers both hardware control systems and modern control technology. The material is presented without bias and without prejudice toward particular hardware or software. Readers with an engineering degree will be reminded of the psychrometric processes associated with heating and air conditioning as they learn of the various controls schemes used in the variety of heating and air conditioning system types they will encountered in the field. Maintenance technicians will also find the book useful because it describes various control hardware and control strategies that were used in the past and are prevalent in most existing heating and air conditioning systems.

Designers of new systems will find the fundamentals described in this book to be a useful starting point, and they will also benefit from descriptions of new digital technologies and energy management systems. This technology is found in modern building HVAC system designs.

ABC Transporters and Multidrug Resistance

A comprehensive review of the most current scientific research on ABC transporters and multidrug resistance

ATP-binding cassette transporter genes (ABC transporters) are known to play a crucial role in the development of multidrug resistance (MDR). MDR is the ability of pathologic cells, such as tumors, to withstand chemicals designed to target and destroy such cells. In MDR, patients who are on medication eventually develop resistance to not only the drug they are taking, but to several different types of drugs.

ABC Transporters and Multidrug Resistance offers an essential resource for pharmaceutical researchers who are working to discover drugs to counteract multidrug resistance in diseases such as cancer. In one comprehensive volume, this book contains a collection of the most current knowledge on the involvement of ABC transporters in drug transport and resistance.

This comprehensive volume provides an overview on the description of the structure, the genome, normal tissue expression, physiological aspect, and mechanism of action of the ABC protein. The expert contributors explore the expression, detection, and implications of ABC proteins in hematological malignancies and solid tumors and ABC proteins and pathogenic microorganisms. This volume also explains MDR modulation through inhibition of ABC transporters and the design of inhibitors and mechanism of action. In addition, the book offers essential information on the biological and clinical aspect of multidrug resistance.

Advances in Pharmacology and Chemotherapy: v. 7


Advances in Pharmacology, Volume 3


Oral Delivery of Macromolecular Drugs: Barriers, Strategies and Future Trends

Recent and rapid progress in the field of biotechnology has resulted in an increasing number of novel macromolecular drugs with great promise for further advanced research and clinical application. However, the delivery of these macromolecular drugs by routes other than the parenteral route is difficult. The pipeline of macromolecular drugs derived from biotechnology presents a challenging opportunity to develop practical dosage forms that could be dosed via the oral route. Given this, the successful oral delivery of macromolecular drugs presents an enormous opportunity. Oral Delivery of Macromolecular Drugs will provide an overview of the innovative oral delivery technologies that have demonstrated success in human testing and will go on to cite the challenges, strategies, and future trends that are to be expected.

Pharm Phlash!: Pharmacology Flash Cards

A classroom-developed, student-tested system that increases pharmacology test scores…decreases and prevents medication errors in the clinical setting…improves NCLEX pharmacology scores…and expands understanding of pharmacological agents! Inside a practical, flip-top box are 189 illustrated, test yourself review cards that cover critical clinical information for nearly 400 of the top generic medications, color-coded by body system and cross referenced by drug classification. These flash cards are not only the ideal supplement to any pharmacology or medical-surgical course, but also handy for care planning and exam prep. And, you can count on them for accuracy, because each card is based on content from Davis's Drug Guide for Nurses.


A color-coded, body-system organization reflects the information common to classes of medications—knowledge crucial to NCLEX success and to reducing medication errors.

- Each card features a single generic drug or a medication group, and details…action • use • pre-administration vital signs • laboratory data assessment • drug levels • patient teaching • and more.
- Drugs are cross-referenced to potential nursing diagnosis and other indications at the bottom of each card.
- Common abbreviations appear on each card, with a summary of the abbreviations on separate, introductory cards.
- A comprehensive alphabetical Index makes it easy to locate drugs within the deck by trade, generic, or Canadian brand name.

European Pharmacopoeia 5th Ed. Main Volume 5.0, 2005

The purpose of the Pharmacopoeia is to promote public health, by the provision of recognised common standards for use by healthcare professionals and others concerned with the quality of medicines.

The monographs and other texts are designed to be appropriate to the needs of regulatory authorities, those engaged in the control of quality, and the manufacturers of starting materials and medicinal products.

Pharmacology: Principles and Practice

This unique and much needed textbook meets the rapidly emerging needs of programs training pharmacologic scientists seeking careers in basic research and drug discovery rather than such applied fields as pharmacy and medicine. While the market is crowded with many clinical and therapeutic pharmacology textbooks, the field of pharmacology is booming with the prospects of discovering new drugs, and virtually no extant textbook meets this need at the student level. The market is so bereft of such approaches that many pharmaceutical companies will adopt Hacker, et al. to help train new drug researchers.

The boom in pharmacology is driven by the recent decryption of the human genome and enormous progress in controlling genes and synthesizing proteins, making new and even custom drug design possible. This book makes use of these discoveries in presenting its topics, moving logically from drug receptors to the target molecules drug researchers seek, covering such modern topics along the way as side effects, drug resistance, Pharmacogenomics, and even nutriceuticals, one in a string of culminating chapters on the drug discovery process.

*Uses individual drugs to explain molecular actions
*Full color art program explains molecular and chemical concepts graphically
*Logical structure reflecting the current state of pharmacology and translational research, starting with receptors and finishing with target molecules
*Covers such intricacies as drug resistance and cell death
*Consistent format across chapters and pedagogical strategies make this textbook a superior learning tool

Good Pharmacovigilance Practice Guide

Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions.The MHRA has identified a need for writing and publishing a guide to "Good Pharmacovigilance Practice". This text complements current legislation and guidance, and provides practical advice about achieving an appropriate system of pharmacovigilance.

Pericyclic Reactions (Oxford Chemistry Primers, 67)

Pericyclic reaction - the third type of organic reaction mechanism along with ionic and radical reactions - include some of the most powerful synthetically useful reactions, like the Diels - Alder reaction, 1,3- dipolar cycloadditions, the Alder ene reaction, Claisen rearrangements, the 2,3-Wittig rearrangement, diimide reduction, sulfoxide elimination and many others. These reactions are characterised by having cyclic transition structures, and also have highly predictable stereochemical features. Every organic chemist must be able to recognise the various types of pericyclic reaction and know something of their mechanisms and the factors that affect how well they work in organic synthesis. This book identifies the four main classes of pericyclic reaction, and discusses the main characteristics of the most important class, cycloadditions - providing a working knowledge, based on real examples, of their scope, patterns of reactivity, and stereochemistry. Then it explains the main features using ideas based in molecular orbital theory, but ( as in the companion book by A. J. Kirby on Stereoelectronic Effects ) without mathematics. It presents the Woodward - Hoffmann rules in the form of two all-encompassing rules, one for thermal reactions and its opposite for photochemical reactions. These rules are explained in detail and carefully illustrated, so that you will be able to predict the stereochemical outcome for any pericyclic reaction. The remaining chapters use this theoretical framework to show how the rules work with the other three classes of pericyclic reactions - electrocyclic reactions, sigmatropic rearrangements and group transfer reactions. By the end of the book, you will be able to recognise any pericyclic reaction and predict with confidence whether it is allowed, and with what stereochemistry, and you will have a working knowledge of the range of pericyclic reactions available to the synthetic organic chemist.

Drug-like Properties: Concepts, Structure Design and Methods: from ADME to Toxicity Optimization

Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a tool and resource for scientists engaged in, or preparing for, the selection and optimization process.

The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays. Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability and metabolic stability, with regard to fundamental understanding, applications of property data in drug discovery and examples of structural modifications that have achieved improved property performance. The authors also review various methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties.

* Serves as an essential working handbook aimed at scientists and students in medicinal chemistry
* Provides practical, step-by-step guidance on property fundamentals, effects, structure-property relationships, and structure modification strategies
* Discusses improvements in pharmacokinetics from a practical chemist's standpoint.

Stockley's Drug Interactions 2009 Pocket Companion

This new edition continues to provide the busy health care professional with a small and conveniently sized quick reference "Stockley" text. "Stockley's Drug Interactions Pocket Companion 2009" draws on the wealth of clinically evaluated, evidence-based information on drug-drug, drug-herb and drug-food interactions that is presented in the full reference work, "Stockley's Drug Interactions".

Stockley’s Drug Interactions Pocket Companion 2009 provides busy healthcare professionals with a small and conveniently sized, quick-reference Stockley text. It draws on the wealth of clinically evaluated, evidence-based information on drug-drug, drug-herb and drug-food interactions that is presented in the full reference work, Stockley’s Drug Interactions .: Follows the familiar format of the Stockley products; Includes over 1500 interaction monographs pertaining to specific drugs or drug groups; Arranged alphabetically for ease of searching; Contains a comprehensive index; Easy-to-use severity rating symbols offer guidance to the user on the clinical significance of the interaction; An essential clinical reference for physicians, pharmacists, nurses and other healthcare professionals. Due to the wide international appeal of this content, the text is now translated into Spanish, Italian and Japanese.

Pharmaceutical Manufacturers: An International Directory

This international directory of pharmaceutical manufacturers includes 1,046 firms in 50 countries. They are arranged alphabetically by country and company name.

In addition to name and address, other information such as telephone and fax number, and key personnel are also listed, where available.

Completing the directory, is a listing of 124 Contract Manufacturers in 19 countries of ethical and/or non-prescription pharmaceuticals. These are arranged alphabetically by country and company name.


Name Reactions and Reagents in Organic Synthesis

This Second Edition is the premier name resource in the field. It provides a handy resource for navigating the web of named reactions and reagents. Reactions and reagents are listed alphabetically, followed by relevant mechanisms, experimental data (including yields where available), and references to the primary literature. The text also includes three indices based on reagents and reactions, starting materials, and desired products. Organic chemistry professors, graduate students, and undergraduates, as well as chemists working in industrial, government, and other laboratories, will all find this book to be an invaluable reference.


Sterilization Validation and Routine Operation Handbook: Radiation

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook, Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical Justify Fullmaterials, drugs and devices.


Pharmaceutics: The Science of Dosage Form Design

A comprehensive textbook covering the design of dosage forms and all aspects of drug delivery systems. 'Pharmaceutics' in its broadest sense is the 'art of the apothecary' or, in simple terms, pharmaceutical preparations. It remains a diverse subject in the pharmacy curriculum, encompassing design of drugs, their manufacture, and the elimination of micro-organisms from the products. This books encompasses all those areas and pays particular attention to the design of dosage forms and their manufacture.


Clinical Pharmacology Made Incredibly Easy!

Clinical Pharmacology Made Incredibly Easy! Third Edition contains everything the health care practitioner needs to review and the student needs to learn about how drugs act and interact in the treatment of disease. The book focuses on mechanisms of drug action; details specific drugs by pharmacologic class for all body systems, plus pain medications, anti-infective drugs, and cancer drugs; and highlights potentially dangerous interactions, including drug-herb interactions. The book pulls together all the necessary facts about drug actions and interactions and presents them with the lighthearted Incredibly Easy! style and tone that makes intimidating concepts thoroughly approachable, easily grasped, and readily retained.


MCQs in Biochemistry

Competitive Examinations are the order of the day. All Colleges conducting professional courses at PG level are admitting students based on common entrance examination, which is of objective type. In Pharmacy, M.Pharm admissions are based on qualifying the GATE enterance examination conducted by Govt. of India. In this book, The author has done good work in preparing several objective questions which help the students to face the subject in the examination with poise and confidence. The book is well balanced and consists of multiple choice questions from all the important topics like carbohydrate metabolism and other important Biochemical aspects. The typesetting and quality of printing is good. The author is also well experienced in taking up this type of work. I recommend this book to all the students preparing for GATE examination and also for Medical and Pharmacy College libraries.


Air Quality, 4th Edition

Ozone-destroying chemicals, greenhouse gases, and dangerous airborne substances that were once thought to be benign are the most urgent issues facing air pollution control experts. Students need a thorough, updated reference that explores these current trends while also covering the fundamental concepts of this emerging discipline. A new revision of a bestseller, Air Quality, Fourth Edition provides a comprehensive overview air quality issues, including a better understanding of atmospheric chemistry, the effects of pollution on public health and the environment, and the technology and regulatory practices used to achieve air quality goals. New sections cover toxicological principles and risk assessment. The book also contains revised discussions on public policy concerns, with a focus on air quality standards for ozone depletion and global warming, and the health effects of particulate air pollutants. This edition continues to serve as a very readable text for advanced level undergraduate and early graduate study in environmental science, environmental management, and in programs related to the study of public health, industrial hygiene, and pollution control.

Powder and Bulk Engineering International July 2009


Pharmaceutical Product Branding Strategies: Simulating Patient Flow and Portfolio Dynamics, Second Edition

This updated Second Edition details how marketers, forecasters, and brand planners can achieve optimal success by building internally consistent simulation models to project future behavior of patients, physicians, and R&D processes. By introducing the reader to the complexities facing many pharmaceutical firms, specifically issues around cross-functional coordination and knowledge integration, this guide provides a framework for dynamic modeling of interest to several pharmaceutical markets, including epidemiology, market definitions, compliance/persistency, and revenue generation in the context of patient flows or movements.

Design and Analysis of Animal Studies in Pharmaceutical Development

This practical resource provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products! Clarifying detailed presentations with real-world examples, Design and Analysis of Animal Studies in Pharmaceutical Development furnishes definitions, background information, and regulatory requirements discusses statistical designs and methods for bioassay describes techniques for estimating drug efficacy and lethal doses illustrates statistical concepts as well as design and analysis principles for toxicology studies shows how to assess carcinogenicity and teratology for drugs under development details methods of analysis for in vitro Ames tests and Chinese hamster ovary cell mutagenesis studies and more!

The Clinical Audit in Pharmaceutical Development

MORIAH Consultants, Yorba Linda, CA. Addresses current issues and trends in the validation and auditing of a clinical study. Covers the concepts of clinical studies and data verification and validation, including the general concept of Good Clinical Practice (GCPs), monitoring, and the role of agencies.

New Drug Approval Process: The Global Challenge

"This text [is] a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." -- Journal of Medicinal Chemistry

"…very valuable…
"…should be a required reading….highly recommended." -- Guarino

"…very valuable… "…should be a required reading for anyone entering the strait-jacket world of modern pharmaceutical development….highly recommended. -- Pharmaceutical Development and Technology

Oxford Pharmaceutical Resources, Inc., Totowa, NJ. Covers the new emphasis on over-the-counter drugs, latest techniques of institutional review boards, Good Clinical Practice standards set by the FDA, adverse drug reaction standards, and more. For professionals in pharmaceutical industry.

Filtration in the Biopharmaceutical Industry

This timely resource offers comprehensive examinations of the most recent developments in the field, from prefiltration methods to final, gas, and tangential flow filtration techniques. Delineates filtration in a host of applications, including virus removal, protein binding, and sterility testing and introduces new, membrane-based technologies for the biopharmaceutical industry! Addressing quality, security, economic, process development, and regulatory topics, Filtration in the Biopharmaceutical Industry presents pre- and sterility grade filters, charge-modified filter media, and aids to filtration discusses filter quality assurance, pore size, extractables, and compatibilities in various filters examines filter design and construction analyzes integrity testing, test sensitivity, and automation furnishes novel filtration flow methods explains filter validation summarizes the U.S. Food and Drug Administration regulations governing filtration and more!


Pharmaceutical Dosage Forms: Parenteral Medication (Volume 3)

University of Tennessee, Memphis. Third and final volume of the second edition of an in-depth text on parenteral medications, for graduate and undergraduate students, and industrial or hospital pharmacists. 17 U.S. contributors. DNLM: Infusions, Parenteral.

Public Relations for Pharmacists

Equips pharmacy professionals with the tools necessary to advance their practice through public relations. The first book designed specifically for pharmacists, it explains how to work with the media; how to write news releases, public service announcements, and op-ed pieces; how to prepare for media interviews; how to work with PR agencies; and how to become involved in the community. The book contains lists of public relations do's and don'ts, points to consider, and tips for succeeding. Examples of successful PR activities and campaign and sample news release, public service announcement, op-ed article, and media pitch letter are also included.

Healthcare Management Dictionary

A comprehensive reference book to help understand clinical and management terms, acronyms and jargon commonly used within the NHS. It includes terms used throughout Primary, Secondary and Social Health Care, and general management terms used throughout the public and private sectors. Website links are provided for further information. This book is aimed at all healthcare professionals and everyone is contact with the NHS and health industry, including academics, pharmaceutical company staff, social services managers and journalists.

Dictionary for Clinical Trials

As a result of the expansion in the area of pharmaceutical medicine there is an ever-increasing need for educational resources. The Dictionary of Clinical Trials, Second Edition comprehensively explains the 3000 words and short phrases commonly used when designing, running, analysing and reporting clinical trials.

This book is a quick, pocket reference tool to understand the common and less well-used terms within the discipline of clinical trials, and provides an alternative to the textbooks available. Terms are heavily cross-referenced, which helps the reader to understand how terms fit into the broad picture of clinical trials.

Wide ranging, brief, pragmatic explanations of clinical trial terminology
Scope includes medical, statistical, epidemiological, ethical, regulatory and data management terminology
Thoroughly revised and expanded - increase of 280 terms from First Edition, reference to Cochrane included
From the reviews of the First Edition:

"This invaluable text explains the majority of clinical trial terms, in alphabetical order, that are likely to be found in clinical trial protocols, reports, regulatory guidelines, and published manuscripts... Fully comprehensive - provides definitions of clinical trial terms in one complete volume... Includes extensive use of graphs throughout." LA DOC STI

"...covers a range of subject matter, with emphasis on medical, statistical, epidemiological and ethical terms... a useful adjunct to standard clinical trial texts... a reference source to keep within easy reach." TALANTA

The Dictionary of Clinical Trials, Second Edition is a ‘must-have’ for all pharmaceutical companies who conduct a lot of clinical trials, in all or one therapeutic area. The book is also of interest for public health and health science workers, and for contract research organisations and departments of medicine, where medics are involved with clinical trials.

Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products (Volume 3 of 6)

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 2 - Regulations, Standards, and Guidelines)

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is presented in an convenient, easy-to-read format, organized to provide fast access to the guidelines and regulations of interest.

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis)

Volume 1 of this three-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

The Japanese Pharmacopoeia Fifteenth Edition (JP XV)

This is the English version of the 15th edition of the "Japanese Pharmacopoeia". It provides the official Japanese standard for the description and quality of drug substances and products. It contains over 1,300 articles regarding: general rules for preparations; processes and apparatus; monographs on drugs; and infrared reference spectra and ultraviolet-visible reference spectra.

Official Monographs provides 1483 articles, including 102 articles newly added and 8 articles deleted. Comprises the following items in order: The Ministry of Health, Labour and Welfare Ministerial Notification; Contents; Preface; General Notices; General Rules for Crude Drugs; General Rules for Preparations; General Tests, Processes and Apparatus; Official Monographs, including Monographs for Crude Drugs; Infrared Reference Spectra; Ultraviolet-visual Reference Spectra; General Information; Atomic Weight Table (2004) and Standard Atomic Weights 2004 as Appendix ; and Cumulative Index (English, Latin and Japanese titles).