Document number 3313-P-3901-PS. Document number C-2- through C-195. Document number D-39 through D-281 PDF Download
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Author: United States. Office of Chief of Counsel for the Prosecution of Axis Criminality
Publisher:
ISBN:
Category : Germany
Languages : en
Pages : 1132
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Author: United States. Office of Chief of Counsel for the Prosecution of Axis Criminality
Publisher:
ISBN:
Category : Germany
Languages : en
Pages : 1132
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Author:
Publisher:
ISBN:
Category : Germany
Languages : en
Pages :
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Author: United States. Congress. House. Post Office and Civil Service
Publisher:
ISBN:
Category :
Languages : en
Pages : 36
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Author:
Publisher:
ISBN:
Category : Science
Languages : en
Pages : 31
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Vols. for 1964- have guides and journal lists.
Author: Dennis Jenke
Publisher: John Wiley & Sons
ISBN: 1119605075
Category : Medical
Languages : en
Pages : 468
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Book Description
EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Author: William Frederick Doolittle
Publisher: Franklin Classics
ISBN: 9780342952328
Category :
Languages : en
Pages : 102
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This work has been selected by scholars as being culturally important and is part of the knowledge base of civilization as we know it. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. To ensure a quality reading experience, this work has been proofread and republished using a format that seamlessly blends the original graphical elements with text in an easy-to-read typeface. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Author: Allen B. Downey
Publisher: "O'Reilly Media, Inc."
ISBN: 1492089435
Category : Computers
Languages : en
Pages : 338
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Book Description
If you know how to program, you're ready to tackle Bayesian statistics. With this book, you'll learn how to solve statistical problems with Python code instead of mathematical formulas, using discrete probability distributions rather than continuous mathematics. Once you get the math out of the way, the Bayesian fundamentals will become clearer and you'll begin to apply these techniques to real-world problems. Bayesian statistical methods are becoming more common and more important, but there aren't many resources available to help beginners. Based on undergraduate classes taught by author Allen B. Downey, this book's computational approach helps you get a solid start. Use your programming skills to learn and understand Bayesian statistics Work with problems involving estimation, prediction, decision analysis, evidence, and Bayesian hypothesis testing Get started with simple examples, using coins, dice, and a bowl of cookies Learn computational methods for solving real-world problems
Author: United States. Environmental Protection Agency. Office of Toxic Substances
Publisher:
ISBN:
Category : Chemical industry
Languages : en
Pages : 580
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Author: Cheng Few Lee
Publisher: World Scientific
ISBN: 9811202400
Category : Business & Economics
Languages : en
Pages : 5053
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Book Description
This four-volume handbook covers important concepts and tools used in the fields of financial econometrics, mathematics, statistics, and machine learning. Econometric methods have been applied in asset pricing, corporate finance, international finance, options and futures, risk management, and in stress testing for financial institutions. This handbook discusses a variety of econometric methods, including single equation multiple regression, simultaneous equation regression, and panel data analysis, among others. It also covers statistical distributions, such as the binomial and log normal distributions, in light of their applications to portfolio theory and asset management in addition to their use in research regarding options and futures contracts.In both theory and methodology, we need to rely upon mathematics, which includes linear algebra, geometry, differential equations, Stochastic differential equation (Ito calculus), optimization, constrained optimization, and others. These forms of mathematics have been used to derive capital market line, security market line (capital asset pricing model), option pricing model, portfolio analysis, and others.In recent times, an increased importance has been given to computer technology in financial research. Different computer languages and programming techniques are important tools for empirical research in finance. Hence, simulation, machine learning, big data, and financial payments are explored in this handbook.Led by Distinguished Professor Cheng Few Lee from Rutgers University, this multi-volume work integrates theoretical, methodological, and practical issues based on his years of academic and industry experience.
Author: United States. Office of Armed Forces Information and Education
Publisher:
ISBN:
Category : Guided missiles
Languages : en
Pages : 64
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Book Description
