Drugs and the Pharmaceutical Sciences (Informa Healthcare) 35±¾

Category: Medical

Tag: Medical/Medicine

Posted on 2007-07-08, updated at 2008-08-20. By anonymous.


Drugs and the Pharmaceutical Sciences (Informa Healthcare) 35±¾

Drugs and the Pharmaceutical Sciences, Series (Informa Healthcare) 35±¾

Dose Optimization In Drug Development (Drugs and the Pharmaceutical Sciences 161)
Krishna ed. (2006)
This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.


Spectroscopy of Pharmaceutical Solids (Drugs and the Pharmaceutical Sciences 160)
Brittain ed. (2006)
Selecting illustrative examples from the recent literature, this reference studies the underlying principles and physics of a wide range of spectroscopic techniques utilized in the pharmaceutical sciences and demonstrates various applications for each method analyzed in the text-showing how knowledge of the mechanisms of spectroscopic phenomena may facilitate more advanced technologies in the field.

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Nanoparticle Technology for Drug Delivery (Drugs and the Pharmaceutical Sciences 159)
Gupta and Kompella eds. (2006)
Nanoparticles, products of nanotechnology, are of increasing interest to the pharmaceutical community. They can increase drug solubility, enhance bioavailability, allow tissue targeting, offer decreased side-effects, and improve therapeutic efficacy. Presenting the most pertinent and practical issues in the manufacturing and biological application of nanoparticles, this source presents state-of-the-art scientific contributions by seasoned authorities in the field.


Pharmacogenomics, Second Edition (Drugs and the Pharmaceutical Sciences 156)
Kalow et al., eds. (2005)
Reflecting the shift from genetics to genomics in the pharmaceutical sphere, this Second Edition traces the evolution of the science of pharmacogenetics and gathers research from the forefront of the field-spanning the most influential breakthroughs in molecular diagnostics, metabonomics, proteomics, bioinformatics, disease mapping, pharmacodynamics, and disease gene identification.


Handbook of Pharmaceutical Granulation Technology, Second Edition (Drugs and the Pharmaceutical Sciences 154)
Parikh ed. (2005)
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.

32 MB

Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences 153)
Baertschi ed. (2005)
The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.


Preclinical Drug Development (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 152)
Rogges (2005)
This reference discusses in detail the broad realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to the regulatory expectations that support clinical trials. Providing chapters on pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling, this guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.


Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences 151)
Nusim ed. (2005)
Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. It offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute manufacturing APIs.



Injectable Dispersed Systems: Formulation, Processing and Performance (Drugs and the Pharmaceutical Sciences 149)

Burgess ed. (2005)
This authoritative guide will serve as the most current source on the design and manufacturing of parenteral dispersed systems-showcasing the utility of dispersed systems in drug delivery, drug targeting, and pharmaceutical engineering.


Drug Delivery to the Oral Cavity: Molecules to Market (Drugs and the Pharmaceutical Sciences 145)
Ghost and Pfister eds. (2005)
With contributions from recognized authorities in industry, academia, and government, this reference presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market.


The Pharmaceutical Regulatory Process (Drugs and the Pharmaceutical Sciences 144)
By Berry (2004)
Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.

12.6 MB rar¡¯d folder of pdf

12.31 MB zip

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition, (Drugs and the Pharmaceutical Sciences 137)
Rey and May (eds.) (2004)
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.


Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 136)
Medina ed. (2003)
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.


Pharmaceutical Inhalation Aerosol Technology, Second Edition, (Drugs and the Pharmaceutical Sciences 134)
Hickey ed. (2003)
This thoroughly revised and expanded reference provides authoritative discussions on the physiologic, pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosol. It analyzes the latest science and developments in the generation, administration and characterization of these compounds, showcasing current clinical applications, the efficiency and limitations of major aerosol products and emerging aerosol therapies impacting the field.

8.8 MB
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Pharmaceutical Extrusion Technology (Drugs and the Pharmaceutical Sciences 133)
Sellassie and Martin (2003)
Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.

10.43 MB pdf
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Pharmaceutical Gene Delivery Systems (Drugs and Pharmaceutical Sciences, 131)
Rolland and Sullivan (eds.) (2003)
This volume examines the advantages and limitations of the major gene delivery systems and offers guidelines to select the most appropriate viral or synthetic delivery system for specific therapeutic applications. It discusses advances in the design, optimization, and adaptation of gene delivery systems for the treatment of cancerous, cardiovascular, pulmonary, genetic, and infectious diseases.

8.73 MB pdf
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Ophthalmic Drug Delivery Systems, Second Edition (Drugs and the Pharmaceutical Sciences 130)
Mitra ed. (2003)
Extensively revised and updated, this second edition compares conventional and innovative drug delivery systems. The book covers significant ophthalmic advances and breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery. It examines procedures in pharmacokinetic/pharmacodynamic modeling for the determination of appropriate dosing regimens, covers new developments in animal modeling, and discusses current regulations governing patenting, commercial product release, and human testing. This in-depth reference lays the groundwork for overcoming constraints on the delivery of ophthalmic drugs.

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Affinity Capillary Electrophoresis in Pharmaceutics and Biopharmaceutics (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 128)
Neubert and Ruttinger eds. (2003)
This volume presents breakthroughs and techniques in affinity capillary electrophoresis to measure and determine the physicochemical and thermodynamic parameters of drug compounds. It discusses strategies to explore and characterize interactions to facilitate developments in controlled drug delivery and targeting.

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Modified-Release Drug Delivery Technology (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 126)
Rathbone et al., eds. (2002)
Describing formulation challenges and their solutions in the design, development, and commercialization of modified-release drugs delivery systems, this book contains eighty papers that review recent developments in design and manufacturing techniques. It includes detailed descriptions of extended release drug products for the oral, nasal, ophthalmic, pulmonary, vaginal, dermal and transdermal pathways. With the exception of the final section addressing regulatory issues, each section covers a particular route for drug delivery and opens with an overview of the anatomical, physiological, and pharmaceutical basics of each route before moving on to cover specific technologies.

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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Patkage Integrity Testing: Third Edition, (Drugs and the Pharmaceutical Sciences 125)
By Michael K. Akers, Dan Larrimore, Dana Guazzo (eds.) (2002)
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.


Good Laboratory Practice Regulations, Third Edition, (Drugs and the Pharmaceutical Sciences 124)
By Sandy Weinberg ed. (2002)
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.


Surfactants and Polymers in Drug Delivery (Drugs and the Pharmaceutical Science 122)
Melmsten ed. (2002)
This reference features the latest findings surrounding the physicochemical aspects of surfactant and polymer systems to facilitate the design and understanding of novel and advanced drug delivery formulations. It covers the basics of surfactant and polymer surface activity and self-assembly, the various types of structures formed by such compounds, and how they may be used in drug delivery. It also discusses solubilization of drugs in micellar systems, liquid crystalline phases formed by PEO-PPO-PEO block copolymers and other copolymers and surfactants, triggered drug-release from liposome formulations, microemulsions formed by ionic and nonionic surfactants, and much more.

Modern Pharmaceutics (Drugs and the Pharmaceutical Sciences, 121)
Banker and Rhodes eds. (2002)
Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration.


Clinical Drug Trials and Tribulations, Second Edition, (Drugs and the Pharmaceutical Sciences 120)
Cato et al. eds. (2002)
Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on¡­ ¡¤ international regulation and deregulation ¡¤ venture capitalist investment ¡¤ the IND process ¡¤ informed consent ¡¤ changes in manufacturing and updated and extended coverage of¡­ ¡¤ pediatric drug trial design ¡¤ the advantages and disadvantages of orphan drug designations ¡¤ the maximization of package inserts for marketing ¡¤ post approval safety surveillance ¡¤ withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.


Dermatological and Transdermal Formulations (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 119)
Walters ed. (2002)
Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems. Recognized international experts discuss the bioequivalence of dermatological and transdermal dosage forms. They explore the biochemistry and treatment of skin diseases, the structure and function of the skin, adverse dermal responses to drug formulations, mechanisms of drug transport through barrier membranes, and methods for measuring and modulating percutaneous permeation.


Handbook of Pharmaceutical Analysis (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 117)
edited by Lena Ohannesian and Anthony J. Streeter (2001)
Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.

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Drug Targeting Technology: Physical, Chemical and Biological Methods (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 115)
Schreier ed. (2001)
Demonstrates how substitution of a variety of ligands can render albumin a versatile targeting tool for selective drug accumulation in various cell populations of the liver! This book discusses physical, chemical, and biological approaches to drug targeting technology, focusing on oral, dispersed system, topical, dermal, transdermal, and inhalation delivery, and the development of original formulations that are matched by innovative device design. Considers the efforts in biotechnology and molecular biology to produce intelligent drug delivery devices by exploiting biological pathways! Containing over 1100 references to facilitate further study, Drug Targeting Technology ¡¤ updates recent progress in oral and colonic targeting technology using pH- and enzyme-sensitive coating materials and novel polymer systems ¡¤ shows how the systemic distribution of drugs can be modulated by lipid-based carriers taking alternative routes of transport, particularly lymph flow ¡¤ details soft drugs that are rapidly metabolized to inactive and nontoxic metabolites and removed efficiently from the body ¡¤ includes successful designs of virus-like liposomal delivery systems that offer the advantages of viral carriers ¡¤ supplies examples of how viral delivery systems can be directed to cancer sites ¡¤ and more! Suggesting harnessing biological processes as the ultimate approach to the delivery or expression of pharmacologically active agents, Drug Targeting Technology is a top-shelf reference for pharmacists, pharmacologists, and pharmaceutical scientists; analytical, surface, physical, and colloid chemists and biochemists; and upper-level undergraduate and graduate students in these disciplines.


Pharmaceutical Process Engineering (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 112)
By Anthony J. Hickey (2001)
Summarizing fundamental engineering principles and operations critical to converting bulk pharmaceutical products into patient-ready and appropriate drug delivery dosage forms, Pharmaceutical Process Engineering facilitates comprehensive understanding of the practical aspects of drug production in an accessible, step-by-step format. It provides a pharmaceutical perspective on unit operations that improves communication among diverse professionals in the field-from pharmaceutical researchers to chemical and industrial engineers-and fully covers the relationship of pharmaceutical development to the application of key concepts and major unit operations in pharmaceutical engineering.


International Pharmaceutical Registration
The increasing globalization of pharmaceutical markets and continuing consolidation within the pharmaceutical industry have highlighted the challenges of rapidly evolving regulatory requirements and created a much greater appreciation of the need for regulatory awareness throughout the industry. This book provides a practical overview and guide to the complexities of international pharmaceutical registration. With individual country chapters written by experts within that country drawn from regulatory authorities, international pharmaceutical companies, and regulatory consultants, the book comprehensively covers regulations across the globe.
International Pharmaceutical Registration has been prepared in response to numerous requests to provide a practical overview and guide to the complexities of pharmaceutical registration internationally. With the increasing globalisation of pharmaceutical markets and continuing consolidation within the pharmaceutical industry, the challenges of rapidly evolving regulatory requirements, including the opportunities presented by increased harmonisation of regulatory guidelines in ternationally have forged a much greater appreciation of the need for regulatory awareness.Individual country chapters are written by national experts from regulatory authorities, international pharmaceutical companies and regulatory consultants. This was an intentional approach to emphasise the partnership involved in regulatory affairs between the regulators and the industry in the spirit of cooperation as reflected in such endeavours as the International Conference on Harmonisation (ICH). Whereas the ICH has focused on the major centres of pharmaceutical research and development, namely the European Union (EU), Japan and the United States, which led to many harmonised guidelines covering these areas (and recognised also in many other countries), the wider international pharmaceutical regulatory world remains much more diverse.

40 MB pdf

Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 109)
Willig ed. (2000)
Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.


Drug Stability: Principles and Practices (Drugs and the Pharmaceutical Sciences 107)
By Carstensen and Rhodes eds. (2000)
Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.

91 MB

Transport Processes in Pharmaceutical Systems (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 102)
Amidon et al., (2000)
This cutting-edge reference clearly explains pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes, whole body kinetics, and drug release from polymer reservoirs and matrices to heat and mass transport in freeze-drying and hygroscopicity. Focuses on practical applications of drug delivery from a physical and mechanistic perspective, highlighting biological systems. Written by more than 30 international authorities in the field, Transport Processes in Pharmaceutical Systems ¡¤ discusses the crucial relationship between the transport process and thermodynamic factors ¡¤ analyzes the dynamics of diffusion at liquid-liquid, liquid-solid, and liquid-cultured cell interfaces ¡¤ covers prodrug design for improving membrane transport ¡¤ addresses the effects of external stimuli in altering some natural and synthetic polymer matrices ¡¤ examines properties of hydrogels, including synthesis, swelling degree, swelling kinetics, permeability, biocompatibility, and biodegradability ¡¤ presents mass transfer of drugs and pharmacokinetics based on mass balance descriptions ¡¤ and more! Containing over 1000 references and more than 1100 equations, drawings, photographs, micrographs, and tables, Transport Processes in Pharmaceutical Systems is a must-read resource for research pharmacists, pharmaceutical scientists and chemists, chemical engineers, physical chemists, and upper-level undergraduate and graduate students in these disciplines.


Peptide and Protein Drug Analysis (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 101)
Reid ed. (1999)
Furthering efforts to simulate the potency and specificity exhibited by peptides and proteins in healthy cells, this remarkable reference supplies pharmaceutical scientists with a wealth of techniques for tapping the enormous therapeutic potential of these molecules-providing a solid basis of knowledge for new drug design. Provides a broad, comprehensive overview of peptides and proteins as mediators of cell movement, proliferation, differentiation, and communication. Written by more than 50 leading international authorities, Peptides and Protein Drug Analysis ¡¤ discusses strategies for dealing with the complexity of peptides and proteins in conformational flexibility and amino acid sequence variability ¡¤ analyzes drug formulations facilitated by solid-phase peptide synthesis and recombinant DNA technology ¡¤ examines chemical purity analysis by high-pressure chromatographic, capillary electrophoretic, gel electrophoretic, and isoelectric focusing methods ¡¤ highlights drug design elements derived from protein folding, bioinformatics, and computational chemistry ¡¤ demonstrates uses of unnatural mutagenesis and combinatorial chemistry ¡¤ explores mass spectrometry, protein sequence, and carbohydrate analysis ¡¤ illustrates bioassays and other new functional analysis methods ¡¤ surveys spectroscopic techniques such as ultraviolet, fluorescence, Fourier transform infrared, and nuclear magnetic resonance (NMR) ¡¤ addresses ways of distinguishing between levels of therapeutic and endogenous agents in cells ¡¤ reviews structural analysis tools such as ultracentrifugation and light, X-ray, and neutron scattering ¡¤ and more! Featuring over 3400 bibliographic citations and more than 500 tables, equations, and illustrations, Peptide and Protein Drug Analysis is a must-read resource for pharmacists; pharmacologists; analytical, organic, and pharmaceutical chemists; cell and molecular biologists; biochemists; and upper-level undergraduate and graduate students in these disciplines.


Protein Formulation and Delivery (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs 99)by Mcnally (1999)
This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development. Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stability!

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Polymorphism in Pharmaceutical Solids (Drugs and the Pharmaceutical Sciences 95)
Brittain ed. (1999)
Presents a comprehensive examination of polymorphic behavior in pharmaceutical development-demonstrating with clear, practical examples how to navigate complicated crystal structures. Edited by the recipient of the American Association of Pharmaceutical Scientists' 1998 Research Achievement Award in Analysis and Pharmaceutical Quality.

3.7 MB pdf file in rar archive

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