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Friday, February 11, 2011

High Resolution NMR: Theory and Chemical Applications, 3rd Edition

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High Resolution NMR provides a broad treatment of the principles and theory of nuclear magnetic resonance (NMR) as it is used in the chemical sciences. It is written at an "intermediate" level, with mathematics used to augment, rather than replace, clear verbal descriptions of the phenomena. The book is intended to allow a graduate student, advanced undergraduate, or researcher to understand NMR at a fundamental level, and to see illustrations of the applications of NMR to the determination of the structure of small organic molecules and macromolecules, including proteins. Emphasis is on the study of NMR in liquids, but the treatment also includes high resolution NMR in the solid state and the principles of NMR imaging and localized spectroscopy.

Careful attention is given to developing and interrelating four approaches - steady state energy levels, the rotating vector picture, the density matrix, and the product operator formalism. The presentation is based on the assumption that the reader has an acquaintance with the general principles of quantum mechanics, but no extensive background in quantum theory or proficiency in mathematics is required. Likewise, no previous background in NMR is assumed, since the book begins with a description of the basic physics, together with a brief account of the historical development of the field.
This third edition of High Resolution NMR preserves the "conversational" approach of the previous editions that has been well accepted as a teaching tool. However, more than half the material is new, and the remainder has been revised extensively. Problems are included to reinforce concepts in the book.

Key Features

* Uses mathematics to augment, not replace, verbal explanations
* Written in a clear and conversational style
* Follows the successful format and approach of two previous editions
* Revised and updated extensively--about 70 percent of the text is new
* Includes problems and references to additional reading at the end of each chapter

NMR-MRI, µSR and Mössbauer Spectroscopies in Molecular Magnets

In the last years, after the discovery of molecular nanomagnets showing novel quantum effects, a renewed interest for the study of molecular magnetism and multifunctional molecular materials has emerged. These materials have triggered an intense research activity also in view of their possible applicabilities as, for example, as nanosized information storage units and as magnetic nanoparticles for bio-medicine. Several fundamental aspects of the microscopic static and dynamic properties of these molecular materials have been obtained by means of spectroscopies using local probes, as nuclei and muons.

In this book an extensive overview on the results obtained during the last decade and on recent achievements in the study of molecular magnets by means of Nuclear Magnetic Resonance, Muon Spin Rotation, Magnetic Resonance Imaging and Mossbauer techniques is presented. The aim is to introduce the reader to these techniques and to give a general background on their application to molecular spin systems.

Carbon-13 NMR Spectroscopy: High-Resolution Methods and Applications in Organic Chemistry and Biochemistry

NMR Spectroscopy in Pharmaceutical Analysis

For almost a decade, quantitative NMR spectroscopy (qNMR) has been established as valuable tool in drug analysis. In all disciplines, i. e. drug identification, impurity profiling and assay, qNMR can be utilized.
Separation techniques such as high performance liquid chromatography, gas chromatography, super fluid chromatography and capillary electrophoresis techniques, govern the purity evaluation of drugs. However, these techniques are not always able to solve the analytical problems often resulting in insufficient methods. Nevertheless such methods find their way into international pharmacopoeias. Thus, the aim of the book is to describe the possibilities of qNMR in pharmaceutical analysis.
Beside the introduction to the physical fundamentals and techniques the principles of the application in drug analysis are described: quality evaluation of drugs, polymer characterization, natural products and corresponding reference compounds, metabolism, and solid phase NMR spectroscopy for the characterization drug substances, e.g. the water content, polymorphism, and drug formulations, e.g. tablets, powders. This part is accompanied by more special chapters dealing with representative examples. They give more detailed information by means of concrete examples. combines theory, techniques, and concrete applicationsall of which closely resemble the laboratory experience considers international pharmacopoeias, addressing the concern for licensing features the work of academics and researchers, appealing to a broad readership.

Methods for Structure Elucidation by High-Resolution NMR

Nuclear Magnetic Resonance Spectroscopy (NMR) is now widely regarded as having evolved into a subscience. The field has become immensely diverse, ranging from medical use through solid state NMR to liquid state applications, with countless books and scientific journals devoted to these topics. Theoretical as well as experimental advance continues to be rapid, and has in fact accelerated by many novel innovations. This multi-authored book focuses on the latest developments in the rapidly evolving field of high resolution NMR, specifically with a view to applications on the structure elucidation of organic molecules of moderate molecular weight. Conceptually it differs from basic educational texts, hard-core scientific papers and regular review articles in that each chapter may be regarded as the authors' personal account of their special insights and results that crystallised after several years of research into a given topic. The book revolves around several themes and offers a handful of scientific "gems" of various colors, reflecting the great diversity of NMR. It contains 16 loosely connected chapters written by some of today's most accomplished NMR scientists in the world. Each chapter is a unique synthesis of the authors' previous research results in the given field, and thus projects special insights. Much emphasis has been given to the latest developments in NMR, in particular to selective pulses and pulsed field gradients. As a part of the series "Analytical Spectroscopy Library", with subsequent editions coming along this book should provide a platform for future research accounts of similar flavor. The material is presented in a mostly non-mathematical fashion, and is intended mainly for chemists, application NMR scientists and students with already some background in NMR. Some of the chapters slightly overlap in the discussed topics, which is particularly exciting in terms of gaining insight into the same area from different angles.

Structure Elucidation by NMR in Organic Chemistry

Structure Elucidation by NMR
in Organic Chemistry: A Practical Guide by Eberhard Breitmaier

amazone review

Structure Elucidation by NMR in Organic Chemistry
Publisher: Wiley | 3 edition (December 3, 2002) | ISBN: 0470850078 | Pages: 270 | PDF | 8.7 MB

This text provides the graduate student with a systematic guide to unravelling structural information from the NMR spectra of unknown synthetic and natural compounds. A brief introduction gives an overview of the basic principles and elementary instrumental methods of NMR. This is followed by instructional strategy and tactical advice on how to translate spectra into meaningful structural information. The book provides the student with 55 sets of spectra of graduated complexity. These are designed to challenge the student's problem-solving abilities by the introduction of new concepts with each group of problems, followed by possible solutions and full explanations. A formula index of solutions is provided at the end of the text. This third edition, following on from the second (a reprint of the first edition with corrections), presents significant new material. Thus, actual methods of two-dimensional NMR such as some inverse techniques of heteronuclear shift correlation, as well as the detection of proton-proton connectivities and nuclear Overhauser effects are included. To demonstrate the applications of these methods, new problems have replaced those of previous editions.

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Monday, February 7, 2011

Testing Computers Systems for FDA/MHRA Compliance

There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment. David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.

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Laboratory Auditing For Quality and Regulatory Compliance

Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance

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

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition
focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

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HVAC Equations, Data, and Rules of Thumb, 2nd Ed.

The Latest Information and “Tricks of the Trade” for Achieving First-Rate HVAC Designs on Any Construction Job!

HVAC Equations, Data, and Rules of Thumb presents a wealth of state-of-the-art HVAC design information and guidance, ranging from air distribution to piping systems to plant equipment. This popular reference has now been fully updated to reflect the construction industry's new single body of codes and standards.

Featuring an outline format for ease of use, the Second Edition of this all-in-one sourcebook contains:

Updated HVAC codes and standards, including the 2006 International Building Code
Over 200 equations for everything from ductwork to air-handling systems
ASME and ASHRAE code specifications
Over 350 rules of thumb for cooling, heating, ventilation, and more
New material including: coverage of the new single body of construction codes now used throughout the country

Inside This Updated HVAC Design Guide

• Definitions • Equations • Rules of Thumb for Cooling, Heating, Infiltration, Ventilation, Humidification, People/Occupancy, Lighting, and Appliance/Equipment • Cooling Load Factors • Heating Load Factors • Design Conditions and Energy Conservation • HVAC System Selection Criteria • Air Distribution Systems • Piping Systems (General, Hydronic, Glycol, Steam, Steam Condensate, AC Condensate, Refrigerant) • Central Plant Equipment (Air-Handling Units, Chillers, Boilers, Cooling Towers, Heat Exchangers) • Auxiliary Equipment (Fans, Pumps, Motors, Controllers, Variable-Frequency Drives, Filters, Insulation, Fire Stopping) • Automatic Controls/Building Automation Systems • Equipment Schedules • Equipment Manufacturers • Building Construction Business Fundamentals • Architectural, Structural, and Electrical Information • Conversion Factors • Properties of Air and Water • Designer's Checklist • Professional Societies and Trade Organizations • References and Design Manuals • Cleanroom Criteria and Standards.

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HVAC: Systems and Equipment (SI Edition)

The 2008 ASHRAE Handbook—HVAC Systems and Equipment discusses various systems and the equipment (components or assemblies) that comprise them, and describes features and differences. This information helps system designers and operators in selecting and using equipment.

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All ICH Guidelines

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

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AHFS Drug Information 2008

First published in 1959, the "Big Red Book," as it's come to be known, has gone the extra mile for pharmacists and healthcare professionals seeking answers to the most detailed questions. It provides more extensive evidence-based data than any other drug reference. AHFS DI is the only reference free from the influence of manufacturers, insurers, regulators, and other special interests, giving you an unbiased source of drug information.

if messages about scripts error bother you try this:first define the drug you want, than click on + to open all subfolder which lie in the medicine name direction, than click on + near folder Document Body Date - and choose AFHS Drug InformationB(2008) - if you will work in such way you will recieve only one message about error.

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Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products

Hardbound. In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given.

Features of this book:

• Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry

• Illustrates the different approaches available to attain robustness

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Pharmacokinetics: Regulatory, Industrial, Academic Perspectives

Offering a unique, multidisciplinary approach, this state-of-the-art Second Edition details the rapidly changing role that clinical and non-clinical pharmacokinetics and drug metabolism play in the discovery and development of drug therapies -- emphasizing often overlooked regulatory, scientific, and economic issues.

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The Pharmaceutical Regulatory Process, Second Edition

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

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ISO 14001 Environmental Certification Step by Step: Revised Edition

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The do-it-yourself manual, with steps to success and simple explanatory notes, designed for real companies. ISO 14001 Environmental Certification Step by Step has been written with smaller companies especially in mind.

Dr. A.J. Edwards explains how to achieve the ISO 14001 standard aided by resources freely available from the accompanying website, including a sample manual and detailed sample registers and procedures. Together, these provide a quick and straightforward guide to achieving the requirements of ISO 14001 Environmental Certification.

This revised edition has been updated to cover the latest developments in the interpretation of the standard, plus changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), Control of Pollution regulations, Dangerous Substances and Explosive Atmospheres Regulations, Landfill charges, Pollution Prevention and Control, and Asbestos Regulations. In addition, the new ISO 19011:2002 standard for auditing is reflected in the book, as are approaches to phased introduction of ISO 14001.

Many organisations working towards ISO 14001 already possess ISO 9000 registration, or choose to achieve ISO 14001 and ISO 9000 simultaneously as an integrated system.To prevent duplication, ISO 14001 Environmental Certification Step by Step includes cross-referencing of ISO 14001 requirements to the relevant procedures in the Quality System.

* A do-it-yourself manual, with steps to success and simple explanatory notes

* Revised and updated to cover developments in the interpretation of the standard, changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), new standards and standards

* Supported by downloadable forms and procedures

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

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

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FDA Administrative Enforcement Manual

A self-contained single source complete with pertinent references and practical outlines for policies and procedures, this book covers how to understand and comply with U.S. drug development and manufacturing regulations. It explores the control of drug research and the manufacturing industry, introduces basic industry experience and techniques, and presents tried and true methods for applying the theory to everyday problems. The author discusses the 10 critical administrative enforcement areas, including recall, application integrity, injunction, seizure, and more, then supplements the topics with regulations, lawsuit case studies, enforcement information, and reference material.

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ORA Quality Manual, January 2007

The ORA Quality Manual contains the required policy elements to structure the Office of Regulatory Affairs (ORA) Quality Management System (QMS). The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and FDA who wish to understand the ORA QMS. Use of this manual presumes some understanding of quality system principles and standards.

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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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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.

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 21^stCentury, 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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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 Productsincludes 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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Regulatory Focus - September 2008

Where is our profession headed?

A Seat at the Table:Regulatory in Corporate Health care

Managing Global Business Risk:The New Role of Regulatory Leaders

Mergers, Acquisitions and Operational Risk

The Regulatory Professional:A Jack of All Trades

Regulating Nanotechnology in the US & EU

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Sunday, February 6, 2011

In Silico Technologies in Drug Target Identification and Validation

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The pharmaceutical industry relies on numerous well-designed experiments involving high-throughput techniques and in silico approaches to analyze potential drug targets. These in silico methods are often predictive, yielding faster and less expensive analyses than traditional in vivo or in vitro procedures. In Silico Technologies in Drug Target Identification and Validation addresses the challenge of testing a growing number of new potential targets and reviews currently available in silico approaches for identifying and validating these targets. The book emphasizes computational tools, public and commercial databases, mathematical methods, and software for interpreting complex experimental data. The book describes how these tools are used to visualize a target structure, identify binding sites, and predict behavior. World-renowned researchers cover many topics not typically found in most informatics books, including functional annotation, siRNA design, pathways, text mining, ontologies, systems biology, database management, data pipelining, and pharmacogenomics. Covering issues that range from prescreening target selection to genetic modeling and valuable data integration, In Silico Technologies in Drug Target Identification and Validation is a self-contained and practical guide to the various computational tools that can accelerate the identification and validation stages of drug target discovery and determine the biological functionality of potential targets more effectively.

New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

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Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than forty respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.

Design of Controlled Release Drug Delivery Systems

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The goal of every drug delivery system is to deliver the precise amount of a drug at a pre-programmed rate to the desired location in order to achieve the drug level necessary for the treatment. An essential guide for biomedical engineers and pharmaceutical designers, this resource combines physicochemical principles with physiological processes to facilitate the design of systems that will deliver medication at the time and place it is most needed.

Nanoparticulates As Drug Carriers

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

Encyclopedia of Controlled Drug Delivery, 2 Volume Set

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

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