Statistical Design and Analysis in Pharmaceutical Science, Chow, Shein-Chung
Автор: Trevor Hastie; Robert Tibshirani; Jerome Friedman Название: The Elements of Statistical Learning ISBN: 0387848576 ISBN-13(EAN): 9780387848570 Издательство: Springer Рейтинг: Цена: 10480.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This major new edition features many topics not covered in the original, including graphical models, random forests, and ensemble methods. As before, it covers the conceptual framework for statistical data in our rapidly expanding computerized world.
Автор: Chow, Shein-Chung , Liu, Jen-pei Название: Statistical Design and Analysis in Pharmaceutical Science ISBN: 0367401878 ISBN-13(EAN): 9780367401870 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: "Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals
Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates--especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors--into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry.
This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book.
Topics covered include:
Drug Approval Process and Regulatory Requirements (private standards)
Pharmacopeias and Compendial Approval Process (public standards)
Common methods in pharmaceutical analysis (typically compendial)
Common Calculations for assays and impurities and other specific tests
Analytical Method Validation, Verification, Transfer
Specifications including how to handle out of specification (OOS) and out of trend (OOT)
Impurities including organic, inorganic, residual solvents and elemental impurities
Good Documentation Practices for regulatory environment
Management of Analytical Laboratories
Analytical Instrument Qualifications including IQ, OQ, PQ and VQ
Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted.
Pharmaceutical Analysis for SmallMolecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
Автор: Zolfaghari, Behrouz, Название: Statistical trend analysis of physically unclonable functions : ISBN: 036775455X ISBN-13(EAN): 9780367754556 Издательство: Taylor&Francis Рейтинг: Цена: 7654.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Statistical Trend Analysis of Physically Unclonable Functions first presents a review on cryptographic hardware and hardware-assisted cryptography. Afterwards, the authors present a combined survey and research work on PUFs using a systematic approach.
Автор: Lewis, Gareth A. , Mathieu, Didier , Phan-Tan-Lu Название: Pharmaceutical Experimental Design ISBN: 0367447746 ISBN-13(EAN): 9780367447748 Издательство: Taylor&Francis Рейтинг: Цена: 9492.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book presents an integrated approach to statistical experimental design to pharmaceutical development, covering all important methods applied to solve the more usual pharmaceutical formulation problem while avoiding mathematical difficulties.
Автор: Berry, D. A. Название: Statistical Methodology in the Pharmaceutical Sciences ISBN: 0367403307 ISBN-13(EAN): 9780367403300 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate
Автор: Thall Peter F. Название: Statistical Remedies for Medical Researchers ISBN: 3030437132 ISBN-13(EAN): 9783030437138 Издательство: Springer Рейтинг: Цена: 11179.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book illustrates numerous statistical practices that are commonly used by medical researchers, but which have severe flaws that may not be obvious.
Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities.
Автор: De Muth, James E. Название: Basic Statistics and Pharmaceutical Statistical Applications ISBN: 0367576163 ISBN-13(EAN): 9780367576165 Издательство: Taylor&Francis Рейтинг: Цена: 7501.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Tsiatis Название: An Introduction To Dynamic Treatmen ISBN: 1498769772 ISBN-13(EAN): 9781498769778 Издательство: Taylor&Francis Рейтинг: Цена: 13779.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Precision medicine seeks to use data to construct principled, i.e., evidence-based, treatment strategies that dictate where, when, and to whom treatment should be applied. This book provides an accessible yet comprehensive introduction to statistical methodology for dynamic treatment regimes.
Описание: Clinical trials require strategic thinking and innovative methods since some traditional methods are not adequate for the 21st century.To solve these problems requires good methodological skills, but also an in-depth knowledge of the practical problems we are dealing with and a strategic vision of the pig picture.
Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
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