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Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
Published: 2008-11-16
Total Pages: 389
ISBN-13: 0387856277
DOWNLOAD EBOOK →This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Author: Steven W. Baertschi
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 626
ISBN-13: 1439801800
DOWNLOAD EBOOK →The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability
Author: Steven W. Baertschi
Publisher: CRC Press
Published: 2005-06-24
Total Pages: 504
ISBN-13: 9780824740214
DOWNLOAD EBOOK →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.
Author: Steven W. Baertschi
Publisher: CRC Press
Published: 2005-06-24
Total Pages: 504
ISBN-13: 9780824740214
DOWNLOAD EBOOK →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.
Author: Tiziano Bellini
Publisher: Academic Press
Published: 2016-11-26
Total Pages: 316
ISBN-13: 0128036117
DOWNLOAD EBOOK →Stress Testing and Risk Integration in Banks provides a comprehensive view of the risk management activity by means of the stress testing process. An introduction to multivariate time series modeling paves the way to scenario analysis in order to assess a bank resilience against adverse macroeconomic conditions. Assets and liabilities are jointly studied to highlight the key issues that a risk manager needs to face. A multi-national bank prototype is used all over the book for diving into market, credit, and operational stress testing. Interest rate, liquidity and other major risks are also studied together with the former to outline how to implement a fully integrated risk management toolkit. Examples, business cases, and exercises worked in Matlab and R facilitate readers to develop their own models and methodologies. Provides a rigorous statistical framework for modeling stress test in line with U.S. Federal Reserve FRB CCAR (Comprehensive Capital Analysis Review), U.K. PRA (Prudential Regulatory Authority), EBA (European Baning Authorithy) and comply with Basel Accord requirements Follows an integrated bottom-up approach central in the most advanced risk modelling practice Provides numerous sample codes in Matlab and R
Author: Joseph Dumit
Publisher: Duke University Press
Published: 2012-09-03
Total Pages: 277
ISBN-13: 0822348713
DOWNLOAD EBOOK →Challenges our understanding of health, risks, facts, and clinical trials [Payot]
Author: Almir Badnjevic
Publisher: Springer
Published: 2017-03-14
Total Pages: 806
ISBN-13: 9811041660
DOWNLOAD EBOOK →This volume presents the proceedings of the International Conference on Medical and Biological Engineering held from 16 to 18 March 2017 in Sarajevo, Bosnia and Herzegovina. Focusing on the theme of ‘Pursuing innovation. Shaping the future’, it highlights the latest advancements in Biomedical Engineering and also presents the latest findings, innovative solutions and emerging challenges in this field. Topics include: - Biomedical Signal Processing - Biomedical Imaging and Image Processing - Biosensors and Bioinstrumentation - Bio-Micro/Nano Technologies - Biomaterials - Biomechanics, Robotics and Minimally Invasive Surgery - Cardiovascular, Respiratory and Endocrine Systems Engineering - Neural and Rehabilitation Engineering - Molecular, Cellular and Tissue Engineering - Bioinformatics and Computational Biology - Clinical Engineering and Health Technology Assessment - Health Informatics, E-Health and Telemedicine - Biomedical Engineering Education - Pharmaceutical Engineering
Author: Sandeep Nema
Publisher: CRC Press
Published: 2010-08-26
Total Pages: 1168
ISBN-13: 1482281783
DOWNLOAD EBOOK →Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products
Author: Joachim Ermer
Publisher: John Wiley & Sons
Published: 2006-03-06
Total Pages: 418
ISBN-13: 3527604472
DOWNLOAD EBOOK →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.
Author: David J. Mazzo
Publisher: CRC Press
Published: 2020-08-26
Total Pages: 354
ISBN-13: 1000161668
DOWNLOAD EBOOK →In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.
