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Pharmaceutical Coating Technology

This book is the definitive work on the theory and practice of pharmaceutical tablet and pellet coating. It describes both the practical and theoretical aspects of tablet coating, including the equipment and methods used in laboratory development, scale-up and production systems, as well as automation and validation. This book also discusses the problems of conforming to world-wide regulations, and the hazards of environmental pollution.

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Controlled Environments May 2008


Controlled Environments - a monthly magazine focused on clean room requirements for aspectic/sterile pharmaceutical & microelectronics manufacturing detailing latest developments in the technology, vista on the scientific background and much more.

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Standardizing Medication Labels

Medications are an important component of health care, but each year their misuse results in over a million adverse drug events that lead to office and emergency room visits as well as hospitalizations and, in some cases, death. As a patient's most tangible source of information about what drug has been prescribed and how that drug is to be taken, the label on a container of prescription medication is a crucial line of defense against such medication safety problems, yet almost half of all patients misunderstand label instructions about how to take their medicines. Standardizing Medication Labels: Confusing Patients Less is the summary of a workshop, held in Washington, D.C. on October 12, 2007, that was organized to examine what is known about how medication container labeling affects patient safety and to discuss approaches to addressing identified problems.

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Oral Drug Absorption: Prediction and Assessment

A practical, hands-on guide for successfully developing oral drug products, this comprehensive reference runs the gamut from theoretical stages of computer-based calculations to practical guidelines for establishing in vitro/in vivo correlations. Coverage details the interrelationship between the physiology of the gastrointestinal tract and oral drug formulations and absorption, and progresses to the latest applications of pharmacokinetic analysis. Includes chapters by the innovators of the Biopharmaceutical Classification Scheme (BCS), human perfusions, and biorelevant dissolution testing! With over 600 literature references, equations, drawings, and photographs, Oral Drug Absorption · offers multiple methods for predicting permeability, solubility, and dissolution for oral bioavailability and bioequivalence · facilitates selection of appropriate drug candidates for development · fully elaborates on the experimental and data analysis techniques of in vitro/in vivo correlations · provides guidance to the Federal Drug Administration's BCS and its applications · appends helpful case studies to the concepts discussed · and much more! Contributions by more than 20 international specialists on the latest research make Oral Drug Absorption an invaluable tool and useful reference in the hands of pharmaceutical scientists, medicinal chemists, pharmacists, pharmacologists, toxicologists, biochemists, gastroenterologists, regulatory personnel, and graduate school students in these disciplines.

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http://rapidshare.com/files/123754625/Oraldrug_absor_preass.zip

Absorption and Drug Development: Solubility, Permeability, and Charge State

Many times drugs work fine when tested outside the body, but when they are tested in the body they fail. One of the major reasons a drug fails is that it cannot be absorb by the body in a way to have the effect it was intended to have. Permeability, Solubility, Dissolution, and Charged State of Ionizable Molecules:
  • Helps drug discovery professionals to eliminate poorly absorbable molecules early in the drug discovery process, which can save drug companies millions of dollars.
  • Extensive tabulations, in appendix format, of properties and structures of about 200 standard drug molecules.

Liquid Filtration

This book is a state-of-the-art review of liquid filtration in the chemical process and allied industries. Interpretations of the phenomenological observations of the hydrodynamics of filtration are given in the hopes of establishing more theoretical and generalized bases of design methodology. Specific design and selection criteria are reviewed, and typical industrial problems and their solutions are presented.

Liquid Filtration is a fundamental unit operation extensively practiced throughout the chemical process, petroleum, and allied industries. It involves the separation, removal, and collection of a discrete phase of matter existing in a dispersed or colloidal state in suspension. This separation is most often performed in the presence of a complex media structure in which physical, physiochemical and/or electrokinetic forces interact.

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http://rapidshare.com/files/123744554/Liq__filt_2Ed.zip

Cellular Drug Delivery: Principles and Practice

An authoritative and up-to-date survey of the fundamental principles, and practice of drug delivery at the cellular level. On the principles side, the authors discuss the broad spectrum of cellular delivery, ranging from coverage of cell-mediated immunity, gene delivery, and protein targeting, to cellular drug transport, cellular drug permeability, and a variety of carrier system related to targeted drug delivery. On the practice side, the authors focus on technological developments in cellular drug delivery, including novel formulations for the delivery of DNA and antisense oligonucleotides ,as well as drug targeting with immunoglobulin formulations and antibody-mediated approaches.

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http://rapidshare.com/files/123260862/Cell_drg_dly.zip


Who Expert Committee on Biological Standardization 55th Report

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterization and establishment of international and other biological reference standards. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.

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Who Expert Committee on Biological Standardization: Fifty-sixth Report

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on quality, safety and effi cacy of live attenuated rotavirus vaccines; DNA vaccines; a biosafety risk assessment for production and quality control of human infl uenza pandemic vaccines; recommendations for inactivated rabies vaccines produced in cell substrates and embryonated eggs; for whole cell pertussis vaccine; and for production, control and regulation of human plasma for fractionation. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.

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Sample Preparation in Chromatography

Sample preparation is an essential step in many analyses. This book approaches the topic of sample preparation in chromatography in a methodical way, viewing it as a logical connection between sample collection and analytical chromatography. Providing a guide for choosing the appropriate sample preparation for a given analysis, this book describes various ways to process the sample, explaining the principle, discussing the advantages and disadvantages, describing the applicability to different types of samples, and showing the fitness to specific chromatographic determinations.

The first part of the book contains an overview of sample preparation showing its relation to sample collection and to the core chromatographic analysis. The second part covers procedures that do not use chemical modifications of the analyte and includes methods for sample dissolution, concentration and cleanup designed mainly for modifying the initial matrix of the sample. This part starts with conventional separations such as filtration and distillation and finishes with more advanced techniques such as solid phase extraction and electroseparations. The third part gives a description of the chemical modifications that can be performed on a sample either for fractionation purposes or to improve a specific property of the analyte. This part includes derivatizations, polymer chemical degradations, and pyrolysis.

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http://rapidshare.com/files/122767475/Sam_pre_chrom.zip

Photostability Of Drugs And Drug Formulations, 2nd Edition

Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features · Assists non-experts in this field design a test protocol and interpret the results · Covers in vitro and in vivo aspects of interactions between drugs and light · Explores the kinetic and chemical aspects of drug photodecomposition · Discusses the problems frequently encountered in photochemical stability testing · Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs · Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint · Offers specific guidance in photostability testing and screening of drug photoreactivity

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http://rapidshare.com/files/122308854/Photost_drugs_formu.zip

Raman and SERS Investigations of Pharmaceuticals

Over the last several years it has become apparent to most researchers that interdisciplinary research is the key to success in the sciences’ future. The present book exemplifies such interdisciplinary work. Thus, some new derivatives have been prepared by chemists and consecutively analyzed by physicists in order to better understand their physical-chemical properties for future tests to be performed by pharmacists. The book consists of an introductory section and other eight chapters. First, the fundamentals of infrared, Raman and surface-enhanced Raman spectroscopy and those of the theoretical methods employed for the vibrational prediction modes are highlighted. The SERS investigations illustrated in the following chapters are focused on different kinds of drugs: tranquilizers and sedatives, anti-inflammatory drugs, vitamins, drugs with anti-bacterial properties, etc. Since there is an increased interest in designing highly effective and controllable SERS-active substrates, a few newly developed substrates that could contribute to a deeper understanding and knowledge of the adsorption behavior of various types of molecules of pharmaceutical and medical interest are also presented.

Lactoferrin: Natural - Multifunctional - Antimicrobial

Lactoferrin is emerging as one of the effective natural antimicrobial intervention in food safety and preservation. Explored in-depth, Lactoferrin: Natural - Multifunctional - Antimicrobial provides you with an introduction to microbial blocking technology and explores its potential as a novel antimicrobial intervention in the multi-hurdle approach to food safety. This book consolidates the science and technological developments in the fast growing area of lactoferrin research.

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http://rapidshare.com/files/121600338/Lactoferrin.zip

Drugs-From Discovery to Approval

Statistics show that out of five thousand compounds with initial promise, five will go into human clinical trials, and only one will become an approved drug. This tiny fraction illustrates the huge complexities involved in bringing a drug to market, a process that brings together scientific research, medical ethics, business, and various regulatory agencies.
Drugs-From Discovery to Approval presents a clear, step-by-step overview of the entire process. Using simple language, this comprehensive guide introduces basic concepts, then moves on to discuss disease target selection and the discovery processes for both small and large molecule drugs. Subsequent chapters explain preclinical studies, clinical trials, regulatory issues, good manufacturing practices (GMPs), and perspectives on the future. Coverage also includes:
* A helpful listing of current FDA and European guidelines
* A special section on regulatory authorities and processes in Japan and China
* Rich illustrations throughout, including more than ninety figures and tables
* Useful appendices on the history of drug discovery and development
* Representative examples of drug mechanisms in action
Written for professionals in the pharmaceutical industry, and readily accessible for students of pharmacy or medicine and others interested in drug discovery, Drugs-From Discovery to Approval represents a practical and approachable reference on this important process.

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http://rapidshare.com/files/121131306/Drgs_fr_disco_appr.zip


The International Pharmacopoeia, Third Edition

Presents an historical account of the Pharmacopoeia and describes methods and procedures for the quality control of pharmaceutical substances and dosage forms, including a special section on quality control of anti-malarials.

Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists

This introductory text highlights the most important aspects of a wide range of techniques used in the control of the quality of pharmaceuticals. Written with the needs of the student in mind, this clear, practical guide includes self-testing sections with arithmetical examples and tests to help students brush up on their arithmetical skills in an applied context.
  • Covers all of the most important analysis techniques in one book.
  • Concentrates on the most important points with just the right level of detail.
  • Summarizes the relevant theory but avoids becoming too esoteric.
  • Features chapter summaries, key points and self-assessment boxes.
  • Includes arithmetical calculations of results in the self-assessment exercises.
  • Additional section on basic calculations in pharmaceutical analysis
  • More detail on the capillary electrophoresis of proteins
  • A discussion of some of the new types of HPLC column and on solvent selectivity in HPLC
  • Additional material inserted on the control of the quality of analytical methods, mass spectrometry and high pressure liquid chromatography
  • Additional self-assessment exercises

Biopharmaceutics Applications in Drug Development

In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics.

Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.