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Pharmaceutical Analysis for Small Molecules : Wiley.- ISBN 9781119121114 СОЕДИНЕННОЕ КОРОЛЕВСТВО, Davani, Behnam


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Автор: Davani, Behnam   (Давани, Бехнам)
Название:  Pharmaceutical Analysis for Small Molecules : Wiley.- ISBN 9781119121114 СОЕДИНЕННОЕ КОРОЛЕВСТВО
Перевод названия: Фармацевтический анализ малых молекул
ISBN: 9781119121114
Издательство: Wiley
Классификация:

ISBN-10: 1119121116
Обложка/Формат: Hardback
Страницы: 256
Вес: 0.67 кг.
Дата издания: 03.10.2017
Серия: Chemistry,Biology, life sciences
Язык: English
Размер: 238 x 161 x 19
Читательская аудитория: Professional & vocational
Ключевые слова: Chemistry,Biology, life sciences
Основная тема: Analytical Chemistry
Ссылка на Издательство: Link
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Поставляется из: Англии
Описание:

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 Small Molecules 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.




An Introduction to Multivariate Statistical Analysis, Third Edition

Автор: T. W. Anderson
Название: An Introduction to Multivariate Statistical Analysis, Third Edition
ISBN: 0471360910 ISBN-13(EAN): 9780471360919
Издательство: Wiley
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Цена: 27712.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: Uses the method of maximum likelihood to a large extent to ensure reasonable, and in some cases optimal procedures. This work treats the basic and important topics in multivariate statistics.

Design and Analysis of Clinical Trials for Predictive Medicine

Автор: Matsui Shigeyuki
Название: Design and Analysis of Clinical Trials for Predictive Medicine
ISBN: 1466558156 ISBN-13(EAN): 9781466558151
Издательство: Taylor&Francis
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Цена: 17609.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание:

Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics--from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.

The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving.

This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.

Workbook for Radiographic Image Analysis

Автор: Kathy McQuillen Martensen
Название: Workbook for Radiographic Image Analysis
ISBN: 0323280714 ISBN-13(EAN): 9780323280716
Издательство: Elsevier Science
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Цена: 9283.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: The companion workbook for Radiographic Analysis, 3rd Edition, provides you with ample opportunities to practice and apply information from the text. With study questions, additional suboptimal images for analysis, and an answer key to guide you through the problems, you'll have all the tools you need to hone your imaging and evaluation skills. Positioning and technique exercises prepare you for success in radiography practice.

Suboptimal images with questions ensure you know and understand what features need to be visible in an image and how to adjust when the images are incorrect or poor. Extra images offer additional practice with identifying poor quality images and recognizing how they are produced. Study questions reinforce text material and prepare you for certification.

NEW! More suboptimal images for analysis and correction help you hone your evaluation skills. NEW! Expansion of pediatric, obesity, and trauma sections provide pertinent information needed for clinical success.

Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition BABE-Solution bundle version

Автор: Chow
Название: Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition BABE-Solution bundle version
ISBN: 1439813582 ISBN-13(EAN): 9781439813584
Издательство: Taylor&Francis
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Цена: 34605.00 р.
Наличие на складе: Поставка под заказ.

Описание: Containing four new chapters, along with several new and updated sections, this third edition reviews the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. It presents the current status of regulations on bioavailability and bioequivalence, including guidelines/guidances issued by the FDA, EMEA, and WHO. This edition addresses frequently asked questions and explores sample size determination, meta-analysis, and pharmacokinetics. It also offers a basic version of PharmaSoftware Solutions, Inc.’s BABE Solution 2008, with bioequivalence assessment for in vivo bioequivalence studies.

Public Policy: Art and Craft of Policy Analysis - 2/E

Автор: SAPRU, R. K.
Название: Public Policy: Art and Craft of Policy Analysis - 2/E
ISBN: 8120344383 ISBN-13(EAN): 9788120344389
Издательство: Mare Nostrum (Eurospan)
Рейтинг:
Цена: 3188.00 р.
Наличие на складе: Нет в наличии.

Описание: Public policy has assumed considerable importance in response to the complexity of economic downturns, social upheavals, political crises, institutional weaknesses and technology. It is concerned not only with the description but also with the developing scientific knowledge about the forces shaping public policy.This textbook, now in its second edition, provides an in-depth study of the various approaches for policy formulation, implementation and evaluation. It addresses issues in policy analysis, and explains the forces that influence the functioning of executive, legislature, judiciary, civil society and administration. The book reviews and evaluates the public policy literature.It is primarily intended for postgraduate students of Political Science and Public Administration for their courses in Public Policy and Policy Analysis. It will be equally useful for policymakers, planners and bureaucrats concerned with policy management.


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