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Quality (Pharmaceutical Engineering Series), Volume 2

The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership.

Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry
Find the answers you are looking for quickly and easily with clear indexing and referencing
Reference to international standards and practice mean this book will be useful wherever you are working.

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ISPE Good Practice Guide - HVAC

The Guide aims to provide a common understanding of critical HVAC issues and a set of common practices to address these issues, gathering together information which is currently included in appendices of the various Baseline Guides into a single resource. The Guide will provide supporting information and HVAC practices and will explore critical and non-critical HVAC issues for the production of pharmaceuticals, biopharmaceuticals, and medical devices.

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Drug Discovery and Development, Drug Development

From first principles to real-world applications-here is the first comprehensive guide to drug discovery and development

Modern drug discovery and development require the collaborative efforts of specialists in a broadarray of scientific, technical, and business disciplines-from biochemistry to molecular biology, organic chemistry to medicinal chemistry, pharmacology to marketing. Yet surprisingly, until now, there were no authoritative references offering a complete, fully integrated picture of the process.

The only comprehensive guide of its kind, this groundbreaking two-volume resource provides an overview of the entire sequence of operations involved in drug discovery and develop-?ment-from initial conceptualization to commercialization to clinicians and medical practitioners.

Volume 1: Drug Discovery describes all the steps in the discovery process, including conceptualizing a drug, creating a library of candidates for testing, screening candidates for in vitro and in vivo activity, conducting and analyzing the results of clinical trials, and modifying a drug as necessary.

Volume 2: Drug Development delves into the nitty-gritty details of optimizing the synthetic route, drug manufacturing, outsourcing, and marketing-including drug coloring and delivery methods.

Featuring contributions from a world-class team of experts, Drug Discovery and Development:

  • Features fascinating case studies, including the discovery and development of erythromycin analogs, Tagamet, and Ultiva (remifentanil)
  • Discusses the discovery of medications for bacterial infections, Parkinson's disease, psoriasis, peptic ulcers, atopic dermatitis, asthma, and cancer
  • Includes chapters on combinatorial chemistry, molecular biology-based drug discovery, genomics, and chemogenomics

Drug Discovery and Development is an indispensable working resource for industrial chemists, biologists, biochemists, and executives who work in the pharmaceutical industry.

High Throughput Bioanalytical Sample Preparation

High Throughput Bioanalytical Sample Preparation: Methods and Automation Strategies is an authoritative reference on the current state-of-the-art in sample preparation techniques for bioanalysis. This book focuses on high throughput (rapid productivity) techniques and describes exactly how to perform and automate these methodologies, including useful strategies for method development and optimization. A thorough review of the literature is included within each of these chapters describing high throughput sample preparation techniques: protein removal by precipitation; equilibrium dialysis and ultrafiltration; liquid-liquid extraction; solid-phase extraction; and various on-line techniques.

The text begins with an introductory overview of the role of bioanalysis in pharmaceutical drug development. Fundamental understanding of the strategies for sample preparation is reinforced next, along with essential concepts in extraction chemistry. Several chapters introduce and discuss microplates, accessory products and automation devices. Particular strategies for efficient use of automation within a bioanalytical laboratory are also presented. The subject material then reviews protein precipitation, liquid-liquid extraction, solid-phase extraction and various on-line sample preparation approaches. The book concludes with information on recent advances in sample preparation, such as solid-phase extraction in a card format and higher density extraction plates.

Important objectives that can be accomplished when the strategies presented in this book are followed include: improved efficiency in moving discovery compounds to preclinical status with robust analytical methods; return on investment in automation for sample preparation; and improved knowledge and expertise of laboratory staff.

· Shows the reader exactly how to perform modern bioanalytical sample preparation techniques, complete with detailed strategies
· Thorough literature review and summary of published information
· Detailed discussion and examples of the method development process

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Microencapsulation: Methods and Industrial Applications, Second Edition

Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of nanotechnology.

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Pharmaceutical Process Scale-Up, Second Edition

Keeping pace with the increased influence of PAT in the pharmaceutical industry, this completely updated reference spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up-clearly introducing readers to the theoretical concept of dimensional analysis to quantify similar processes on varying scales.

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Thermal Analysis of Pharmaceuticals

As a result of the Process Analytical Technologies (PAT) initiative launched by the U.S. Food and Drug Administration (FDA), analytical development is receiving more attention within the pharmaceutical industry. Illustrating the importance of analytical methodologies, Thermal Analysis of Pharmaceuticals presents reliable and versatile characterization tools for the successful development of pharmaceutical products. It draws attention to the most widely applicable methods and demonstrates how to interpret the associated data.

The book opens with the first three chapters devoted to differential scanning calorimetry (DSC), the most commonly used thermal method. These chapters cover the principles, optimal use, and pharmaceutical applications of the method. Subsequent chapters explore modulated temperature DSC, thermogravimetric analysis, thermal microscopy, microcalorimetry, high sensitivity DSC, dynamic mechanical analysis, and thermally stimulated current, all of which have attracted great interest within the pharmaceutical field. The chapters include theoretical background, measurement optimization, and pharmaceutical applications of each technique.

Exploring important techniques for characterizing the physical structure and properties of pharmaceutical materials, Thermal Analysis of Pharmaceuticals achieves an ideal balance in the depth, relevance, and accessibility of topics presented. The book provides an excellent overview of this key area in pharmaceutical development.

Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-Soluble Drugs

Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem of major significance, the pharmaceutical industry has been slow to apply and further develop this technology. This title provides a comprehensive summary of the theoretical and practical aspects of oral lipid-based formulations for use in industry, and provides further insights into a developing technology expected to assume increasing prominence in years to come.

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Elsevier's Dictionary of Vitamins and Pharmacochemistry

The dictionary will contain terms covering the following fields and subfields: Vitamin Technology: Vitamin biochemistry / Physiology; Origin of vitamins: natural, synthetic; Fat-soluble vitamins; Water-soluble vitamins; Vitamins as antioxidants; Vitamin deficiencies / Hypervitaminosis - Enzymes/Proteins: Biotechnology as applied biological science aimed at industrial exploitation - Hormones: Biochemistry; Physiology - Pharmaceutical Chemistry / Pharmaceutical Technology / Pharmaceutical Processes: Conception of the active principles; Structural analysis; Antibiotics and their way of action; Biochemistry; The Drug / The Medicament: Definition, origin, way of action; Biochemistry - Medical Aspects in the languages English, German, French and Portuguese.

*An important resource for pharmacologists, pharmaceutists and medical doctors
*Includes definitions in several prominent languages (English, German, French, Portuguese)
*Covers subfields of Vitamin Technology, Enzymes/Proteins, Hormones, Pharmaceutical Chemistry, Pharmaceutical Technology, Pharmaceutical Processes, and more.

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Basic & Clinical Pharmacology

The current science of pharmacology-and its clinical applications-at your fingertips

Now in its 25th year of publication, Basic and Clinical Pharmacology is the most up-to-date and complete pharmacology textbook available. Through nine previous editions it has set the standard for concise and easy-to-read, yet comprehensive coverage of pharmacology. The text's integration of basic with clinical science makes it well suited for an integrated organ-system-based curricula as well as the more traditional curricula.

Features

  • In-depth coverage of key pharmacology topics, from basic principles to pharmacologic considerations for autonomic, cardiovascular-renal, smooth muscle, CNS, endocrine, antimicrobial, and chemotherapeutic and immunotherapeutic drugs
  • Updated with dozens of new, recently approved drugs, including monoclonal antibodies
  • Detailed review of the mechanism of action and toxicities of traditional and newer drugs
  • Critical discussions of treatment strategies and recommended drugs for all major diseases
  • Valuable section on toxicology that provides an introduction to occupational and environmental toxicology; heavy metal intoxication and chelators; and management of the poisoned patient
  • Ready-to-use, study-enhancing features, including special interest boxes, lists of common preparations, and dosage information
  • Unique evidence-based chapters on abused drugs; special aspects of perinatal, pediatric, and geriatric pharmacology; and over-the-counter drugs, herbal medications, and nutritional supplements
  • More than 500 concept-clarifying illustrations and tables throughout
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  • Clinical Studies Management - A Practical Guide to Success

    A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R&D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development processes and trends that are driving change. It is a resource for anyone who wishes to sharpen their study management skills.

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    A Manager's Guide to the Design and Conduct of Clinical Trials

    This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.

    Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards.

    This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-includethe following material:

    * Should the trials be conducted?
    * Put it in the computer and keep it there
    * Staffing for success
    * Designing trials and determining sample size
    * Budgeting
    * Recruiting and retaining patients and physicians
    * Data management
    * Monitoring the trials
    * Data analysis
    * After action review
    * Exception handling

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

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

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

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

    Future of Glycerol: New Usages for a Versatile Raw Material

    This book aims to inform chemistry professionals, including managers and technologists, on the large potential of glycerol as versatile biofeedstock for the production of a variety of chemicals, polymers and fuels. Whilst filling a gap in the current literature, this nicely illustrated book is written in a clear, concise style and presents the numerous uses of glycerol as a new raw material which are starting to have an impact on industry worldwide. Elucidation of the principles governing the new chemistry of glycerol goes along with updated industrial information that is generally difficult to retrieve.

    Through its 10 chapters, the monograph tells the story of a chemical success that of converting glycerol into value added products and highlights the principles that made it possible. Whether as solvent, antifreeze, detergent, monomer for textiles or drug, new catalytic conversions of glycerol have been discovered that are finding application for the synthesis of products whose use range from everyday's life to the fine chemical industry.

    Readers are also shown how a number of practical limitations posed by glycerol chemistry, such as the low selectivity encountered employing traditional stoichiometric and older catalytic conversions, were actually solved based on the understanding of the fundamental chemistry of glycerol and by application of catalysis science and technology.

    Readers also find a thorough discussion on the sustainability issues of bioglycerol production covering societal, environmental and economic dimensions to reflect the needs of politicians and citizens of today who require cross border research. By explaining the advantages and problems as well as offering solutions the book aids understanding as to whether biodiesel and glycerol refineries are convenient and economically sound.

    Pharmaceutical and Medical Device Validation by Experimental Design

    This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational approach to use, using realistic case studies, illustrations, and where appropriate, step-by-step protocols and procedures.

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    Pharmacy Law and Practice

    This textbook explains what pharmacy students and practicing pharmacists need to know about pharmacy and the law, including recent changes in the National Health Service. The book provides easy accessibility amd concise, yet comprehensive information. There have been many changes in the NHS and in the law relating to pharmacy since the first edition was written. Therefore, the book has been thoroughly revised, and the text re-organized.

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    Handbook of Membrane Separations: Chemical, Pharmaceutical, Food, and Biotechnological Applications

    The Handbook of Membrane Separations: Chemical, Pharmaceutical, and Biotechnological Applications provides detailed information on membrane separation technologies as they have evolved over the past decades. To provide a basic understanding of membrane technology, this book documents the developments dealing with these technologies. It explores chemical, pharmaceutical, food processing and biotechnological applications of membrane processes ranging from selective separation to solvent and material recovery. This text also presents in-depth knowledge of membrane separation mechanisms, transport models, membrane permeability computations, membrane types and modules, as well as membrane reactors.

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    Mechanisms of Transdermal Drug Delivery

    Provides an up-to-date and critical examination of biophysical techniques used in the analysis of molecular mechanisms underlying transdermal drug delivery as well as a physical and chemical evaluation of the stratum corneum necessary for the enhancement of percutaneous drug transport. Reflects the hands-on experience of established and novel researchers in the field.

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    Advanced Drug Design And Development: A Medicinal Chemistry Approach

    This volume, entitled Advanced Drug Design and Development: A Medicinal Chemistry Approach, is a collection of lectures by most of the invited speakers in The Department of Pharmaceutical-Medicinal Chemistry, School of Pharmacy, Aristotelian University of Thessaloniki.about the new trends in our science, through the presentations of renowned invited speakers. It is also aimed to create a forum for exchange of ideas in medicinal chemistry, in a different informal environment, bringing internationally recognized medicinal chemists closer to their Greek colleagues.

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    Validation of Pharmaceutical Processes, 3rd Edition

    Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title · provides an in-depth discussion of recent advances in sterilization · identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions · explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results · blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

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    Combination Products: Regulatory Challenges and Successful Product Development

    The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality issues that arise when combining drugs, biologics, and medical devices into a single product. It takes a practical, readily applicable approach to discussing the challenges, victories, and pitfalls associated with merging technologies and systems and how to implement these products into the market successfully and in a timely manner. Specifically, this text explores the process from start to finish, establishing a workable design and development plan complete with relevant definitions. It reviews FDA and other regulatory expectations and covers resource requirements, manufacturing pitfalls, post-launch compliance requirements, and agency audits and challenges. Drawing on the experience and expertise of two leaders in their respective fields, Combination Products boasts the credentials of Dr. Smita Gopalaswamy, a 20 year veteran of technical consulting responsibilities in medical device, biologics, and pharmaceutical industries as well as combination products, along with the support of Dr. Venky Gopalaswamy, an expert in business improvement methodologies such as six sigma, lean, and change management, to provide a comprehensive assessment of the field and an efficient and effective approach to the creation and implementation of combination products.

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    Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition

    Thoroughly updated and expanded, this new 3rd edition provides the latest information on dosage, forms, film defects, and polymer characterization. Written by renowned leaders in the field, Aqueous Polymeric Coatings for Pharmaceutical Dosage Formsis easily the most comprehensive book available on the market today.

    New to the 3rd Edition:

    · the interaction of drugs with functional polymers

    · the influence of processing parameters on coating quality

    · the stabilization of polymeric film coats

    · plastisizers and their applications in pharmaceutical coatings

    · adhesion of polymeric films to solid substrates

    · basic properties of latex and pseudolatex colloidal dispersions

    Key topics included:

    · polymer interactions with drugs and excipients

    · physical aging of polymeric films.

    · A complete overview and in-depth analysis of recent advances in the field, which includes information on the latest equipment used to apply polymers to a pharmaceutical system

    · illustrated examples explaining the appropriate steps to be taken in order to solve formulation, processing and stability problems to achieve an optimized dosage form.

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    Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

    This Second Edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.

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    HPLC Methods for Pharmaceutical Analysis, Volumes 2-4

    The most commonly used method for analyzing substances, and the first method most researchers turn to, is high performance liquid chromatography (HPLC). Following up on a best-seller, volumes 2-4 continue to provide an easily-accessible collection of procedures for analyzing pharmaceuticals using HPLC.

    Download Links:

    http://rapidshare.com/files/136972018/tHPLCMet_pharmaana_v2-4.part1.rar
    http://rapidshare.com/files/136980254/tHPLCMet_pharmaana_v2-4.part2.rar
    http://rapidshare.com/files/136984873/tHPLCMet_pharmaana_v2-4.part3.rar

    Medicines, 6th ed

    This is the sixth edition of Medicines: The Comprehensive Guide – the most popular and best-selling dictionary-style reference source-book for the range of medicines, along with possible side-effects, that is available in the UK today. Previous editions of this book have sold almost two million copies. The text has been extensively revised – to take account of the many new drugs, both generic and proprietary, as well as entire new drug groups, that have been developed and marketed since publication of the fifth edition in 2000. Changes in details of those medicines that remain on the market are also included. Requests from the public have led to the inclusion in this edition of expanded warnings about possible interactions between drugs with other medicines – especially those that can be obtained without a prescription –herbal remedies and nutritional supplements. There is also an expanded glossary of medical terms, which hopefully readers will find useful in understanding some of the more technical terms.

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    http://rapidshare.com/files/136460846/tmedicines6ed.zip

    Pharmacovigilance, 2nd edition


    Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. .

    • The editors and contributors are of excellent standing within the pharmacovigilance community
    • The text provides exemplary coverage of all the relevant issues
    • The definitive book on the subject
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    Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition

    Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity.

    Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.

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    http://rapidshare.com/files/136438447/Micro_cont_pharma2ed.zip


    Analytical Profiles of Drug Substances and Excipients, Volume 27

    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.

    Edited by the Associate Director of Analytical Research and Development for the American Association of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together in one source. The scope of the series has recently been expanded to include profiles of excipient materials.

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    http://rapidshare.com/files/136435803/tanaprodrug_Subs_exp_vol27.zip

    Methods of Analysis for Functional Foods and Nutraceuticals

    Written by experts at the forefront of phytochemical analysis, this book covers the important classes of bioactive components of functional foods and nutraceuticals. It also includes some components for which no acceptable methods of analysis are yet available. Organized by compound class, Methods of Analysis for Functional Foods and Nutraceuticals provides a central resource and a valuable reference for the analysis of well known functional food components, such as carbohydrates, lipids, and vitamins, and a unique resource for descriptions of the analytical methodology for non-nutritive food ingredients.

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    http://rapidshare.com/files/135973357/tmoa_food_nutra.zip

    Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition

    Thoroughly acquainting the reader with freeze-drying fundamentals-including water properties critical to the process and mechanisms and means of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures-ensuring the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation.

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    http://rapidshare.com/files/135770884/Tfreeze_DryingLyop2Ed.zip

    Handbook of Pharmaceutical Granulation Technology, Second Edition

    Applying basic theories to industrial practices in pharmaceutical development, this Second Edition explains how new and emerging technologies are utilized in the production of pharmaceutical granulation-demonstrating cost-effective strategies to manufacture solid-dosage forms with consistent physical properties while complying with current regulatory requirements. New chapters cover process modeling, scale-up considerations, rapid release granulation techniques, melt granulation and pelletization, effervescent granulation, rapid release, and process analytical technology. Updated sections cover the theory of granulation from an engineering perspective and the regulatory standards.

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    http://rapidshare.com/files/135475717/tpharma_granu_tech2ed.zip

    Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Patkage Integrity Testing: Third Edition

    Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.

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    http://rapidshare.com/files/135471632/tparenteralqc.zip

    Neonatal Formulary: Drug Use in Pregnancy and the First Year of Life

    The Neonatal Formulary is a unique book providing advice on the safe use of drugs during pregnancy, labour and throughout the first year of life. Thoroughly updated, this fifth edition draws on the experience of an increasingly international group of neonatologists and is now a well established reference on prescribing in infancy. It covers all the drugs commonly used in the perinatal period, including those used for fetal treatment, and summarizes how the prescribing of each has to adapt to changes in drug elimination during the first year of life.

    Key features for the fifth edition include:

    • fully updated monographs and references
    • 20 full monographs for diseases more commonly seen in the tropics
    • invaluable information on dose sizes and administration for babies
    • further inclusion of evidence from relevant RCTs and systematic reviews from the Cochrane database
    • a free access website with regular updates and links to other useful information.

    Pharmaceutical Project Management, Second Edition

    Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through manufacturing and launch.

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    http://rapidshare.com/files/135443232/tpharmap_projmgmt2ed.zip

    Interpretation of Mass Spectra - 4Ed

    This book covers the basics of mass spectra, and how to interpret them by hand. While it doesn't really go into modern developments, its certainly a great way to get started thinking about mass spectroscopy in general. Probably most useful for an undergraduates course in spectroscopy, which is where I first came across it. The nice thing is it has lots of exercises for the reader that are actually alot of fun. Does not, unfortunately, address protein identification and sequencing by mass spec at al, so while I recommend this book as a starting point, a biologically oriented reader would best use this book in conjunction with a more protein-specific reference.

    Download Link:

    http://rapidshare.com/files/135220391/Interpr_mspectra4Ed.zip