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Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
Published: 2008-11-16
Total Pages: 389
ISBN-13: 0387856277
DOWNLOAD EBOOKThis 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: 2005-06-24
Total Pages: 504
ISBN-13: 9780824740214
DOWNLOAD EBOOKThe 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: 318
ISBN-13: 0128036117
DOWNLOAD EBOOKStress 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: Almir Badnjevic
Publisher: Springer
Published: 2017-03-14
Total Pages: 806
ISBN-13: 9811041660
DOWNLOAD EBOOKThis 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: Kim Huynh-Ba
Publisher: John Wiley & Sons
Published: 2022-04-19
Total Pages: 420
ISBN-13: 1119120918
DOWNLOAD EBOOKProvides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Author: Andrew Teasdale
Publisher: John Wiley & Sons
Published: 2017-09-29
Total Pages: 624
ISBN-13: 1118971132
DOWNLOAD EBOOKExamining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author: Joseph Dumit
Publisher: Duke University Press
Published: 2012-09-03
Total Pages: 277
ISBN-13: 0822348713
DOWNLOAD EBOOKChallenges our understanding of health, risks, facts, and clinical trials [Payot]
Author: David C Lee
Publisher: John Wiley & Sons
Published: 2009-02-12
Total Pages: 384
ISBN-13: 1405172991
DOWNLOAD EBOOKThe use of analytical sciences in the discovery, development andmanufacture of pharmaceuticals is wide-ranging. From the analysisof minute amounts of complex biological materials to the qualitycontrol of the final dosage form, the use of analytical technologycovers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drugdevelopment and manufacture, focusing on the analysis of the activeingredient or drug substance. It provides those joining theindustry or other areas of pharmaceutical research with a source ofreference to a broad range of techniques and their applications,allowing them to choose the most appropriate analytical techniquefor a particular purpose. The volume is directed at analytical chemists, industrialpharmacists, organic chemists, pharmaceutical chemists andbiochemists.
Author: Joachim Ermer
Publisher: John Wiley & Sons
Published: 2006-03-06
Total Pages: 418
ISBN-13: 3527604472
DOWNLOAD EBOOKAdopting 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: Mark Gibson
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 562
ISBN-13: 1420073184
DOWNLOAD EBOOKPharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne
