Q.C. & ANALYTICAL PROFILES
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Analytical Profiles of Drug Substances and Excipients , vol 28
Analytical Profiles of Drug Substances and Excipients
Academic Press ISBN: 0122608267 1999-10-05 PDF 508 pages 12 Mb
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 into one source. The scope of the series has recently been expanded to include profiles of excipient materials.
Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)
By Richard J. Smith, Michael L. Webb
Publisher: Wiley-Blackwell
Number Of Pages: 288
Publication Date: 2007-05-04
ISBN-10 / ASIN: 1405133589
ISBN-13 / EAN: 9781405133586
Binding: Hardcover
The presence of impurities, even in small amounts, may affect the efficacy and safety of pharmaceuticals. The methods for detecting and controlling them are subject to continuous review and improvement. Characterisation of impurities is a crucial aspect of drug development and approval, and is central to quality control.
This book provides a source of reference on the techniques available for accurate identification and quantification of drug impurities, and it brings together all the relevant disciplines within one volume for the first time.
Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including:
- Acute toxicity testing in pharmaceutical safety evaluation
- Genotoxicity
- Safety assessment of inhalant drugs
- Immunotoxicology in pharmaceutical development
- Large animal studies
- Evaluation of human tolerance and safety in clinical trials
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The second volume of the Compendium on quality assurance of pharmaceuticals has been updated to include all new and revised texts published by WHO through the end of 2003 in the area of good manufacturing practices (GMP), inspection and the use of risk analysis in production of pharmaceuticals. All together it includes 15 different guidance texts which were all adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The texts have been developed, revised and reviewed in a consultative process through participation of members of WHO expert panels, specialists, international professional associations , institutions, international organizations, NGOs and other third parties recognized as being competent in this field. The texts cover good manufacturing practices and inspection of production sites and distribution channels, as well as the quality system requirements of national GMP inspectorates. The good manufacturing practices include main principles as well as supplementary texts for a number of specific types of products. There are in total six new guidance texts ; two guidelines have been updated.
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Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
Publisher: Informa Healthcare 2007-08-22 ISBN 0849303958 Pages: 550 PDF 17 MB
Publisher: Informa Healthcare 2007-08-22 ISBN 0849303958 Pages: 550 PDF 17 MB
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.
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Quality Control Methods For Medicinal Plant Materials
WHO ISBN: 9241545100 1998 PDF 123 pages 1.61 Mb RS
Steven A. Haney “High Content Screening: Science, Techniques and Applications"
Wiley-Interscience 2008-01-18 ISBN: 047003999X 424 pages PDF 11,3 Mb
Wiley-Interscience 2008-01-18 ISBN: 047003999X 424 pages PDF 11,3 Mb
This book provides comprehensive coverage of high content screening (HCS) and serves as an important reference for researchers in academics, biotechnology, and pharmaceutical companies. It covers varied and important subjects like: assay development, applications for drug discovery and development, cell culture, image processing, database architecture and management, and model systems for analysis.
Handbook of Modern Pharmaceutical Analysis (Separation Science and Technology)
Academic Press 2001-07-27 ISBN: 0120455552 600 pages PDF 9,2 Mb
This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories.
No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.
 Publisher: Wiley-VCHLanguage: english ISBN: 3527310959 Paperback: 386 pages Data: March 10, 2006 Format: PDF Description: Edited by one of the leading experts in the field, this book fills the need for a book presenting the most important methods for high-throughput screenings and functional characterization of enzymes. It adopts an interdisciplinary approach, making it indispensable for all those involved in this expanding field, and reflects the major advances made over the past few years. For biochemists, analytical, organic and catalytic chemists, and biotechnologists. Скачать Download - (3 Mb) |
Raman and SERS Investigations of Pharmaceuticals
Springer 2008 ISBN: 3540782826 214 pages PDF 2 MB
Over the last several years it has become apparent to most researchers that interdisciplinary research is the key to success in the sciences’ future. The present book exemplifies such interdisciplinary work. Thus, some new derivatives have been prepared by chemists and consecutively analyzed by physicists in order to better understand their physical-chemical properties for future tests to be performed by pharmacists. The book consists of an introductory section and other eight chapters. First, the fundamentals of infrared, Raman and surface-enhanced Raman spectroscopy and those of the theoretical methods employed for the vibrational prediction modes are highlighted. The SERS investigations illustrated in the following chapters are focused on different kinds of drugs: tranquilizers and sedatives, anti-inflammatory drugs, vitamins, drugs with anti-bacterial properties, etc. Since there is an increased interest in designing highly effective and controllable SERS-active substrates, a few newly developed substrates that could contribute to a deeper understanding and knowledge of the adsorption behavior of various types of molecules of pharmaceutical and medical interest are also presented.
Quality Assurance in Analytical Chemistry: Applications in Environmental, Food and Materials Analysis, Biotechnology, and Medical Engineering
 Paperback: 300 pages Data: January 9, 2007 Format: PDF Description: This best-selling title both in German and English is now enhanced by a new chapter on the important topical subject of measurement uncertainty, plus a CD-ROM with interactive examples in the form of Excel-spreadsheets. These allow readers to gain an even better comprehension of the statistical procedures for quality assurance while also incorporating their own data. Following an introduction, the text goes on to elucidate the 4-phase model of analytical quality assurance: establishing a new analytical process, preparative quality assurance, routine quality assurance and external analytical quality assurance. Besides updating the relevant references, the authors took great care to incorporate the latest international standards in the field. Download - (2 Mb) | ||
Hardcover: 418 pages
Publisher: Wiley-VCH (May 6, 2005) English ISBN-10: 3527312552 ISBN-13: 978-3527312559
File type : PDFFile
size : 2.9 MB
Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
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(Drugs and the Pharmaceutical Sciences)
Pharmaceutical Stress Testing (Drugs and the Pharmaceutical Sciences)
Author: Steven W. Baertschi (Editor)
Publisher: Informa Healthcare
PDF 504 pages 7,7mb English language ISBN 0824740211The 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.
Pharmaceutical Stress Testing (Drugs and the Pharmaceutical Sciences)
Author: Steven W. Baertschi (Editor)
Publisher: Informa Healthcare
PDF 504 pages 7,7mb English language ISBN 0824740211The 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.
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