Statistical Design and Analysis in Pharmaceutical Science, Chow, Shein-Chung , Liu, Jen-pei
Автор: Burdick Richard K., Leblond David J., Pfahler Lori B. Название: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 3319843389 ISBN-13(EAN): 9783319843384 Издательство: Springer Рейтинг: Цена: 74530.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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.
Автор: Hildebert Wagner; Stefanie P?ls; Talee Barghouti; Название: Chromatographic Fingerprint Analysis of Herbal Medicines Volume V ISBN: 3319883720 ISBN-13(EAN): 9783319883724 Издательство: Springer Рейтинг: Цена: 139750.00 T Наличие на складе: Поставка под заказ. Описание: Volume V of this manual provides an overview of the analytical investigation of numerous additional Chinese herbal drugs that are commonly used in Traditional Chinese Medicine (TCM).
Автор: Watson, David G. (Senior Lecturer in Pharmaceutical Sciences, Strathclyde Institute of Pharmaceutical and Biomedical Sciences, University of Strathcly Название: Pharmaceutical and Medicinal Chemistry. Elsevier,2011 ISBN: 9780443072321\Давид Уотсон:Фармацевтическая и лекарственная химия, Элзивир,2011 ISBN: 0443072329 ISBN-13(EAN): 9780443072321 Издательство: Elsevier Science Рейтинг: Цена: 49390.00 T Наличие на складе: Поставка под заказ. Описание: Intends to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. This book emphasizes on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target.
Автор: Lal, H. Название: Essentials of Pharmaceutical Biochemistry: CBS Publishers & Distributrors, 2019.- ISBN: 9789386478580 /Основы фармацевтической биохимии, включая практические упражнения ISBN: 9386478587 ISBN-13(EAN): 9789386478580 Издательство: CBS India Рейтинг: Цена: 31350.00 T Наличие на складе: Нет в наличии. Описание: This book includes all of the theory as well as the practical side of pharmaceutical biochemistry, presented in a simple, yet comprehensive, way. It includes chapters on topics such as biomolecules, biogeneratics, energy rich compounds, biological oxidation, the catalytic role of enzymes, the importance of enzyme inhibitors in the design of new drugs, and therapeutic and diagnostic applications of enzymes.
Автор: Burdick Название: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 3319501844 ISBN-13(EAN): 9783319501840 Издательство: Springer Рейтинг: Цена: 79190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities.
Автор: Berry, D. A. Название: Statistical Methodology in the Pharmaceutical Sciences ISBN: 0367403307 ISBN-13(EAN): 9780367403300 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T 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: Niazi Название: Handbook Bioequivalence Testing 2E ISBN: 1482226375 ISBN-13(EAN): 9781482226379 Издательство: Taylor&Francis Рейтинг: Цена: 193950.00 T Наличие на складе: Невозможна поставка. Описание: This year`s session was marked by substantial steps forward to support the reform process launched in 2009 with the aim to modernise the institutional framework and ensure a more efficient functioning of the commission. In addition the session adopted guidelines on precautionary conservation measures aimed at minimizing undesirable effects on stocks and improving fisheries economic profitability.
Название: Method Validation in Pharmaceutical Analysis: A Guide to Best Practice ISBN: 3527335633 ISBN-13(EAN): 9783527335633 Издательство: Wiley Рейтинг: Цена: 154120.00 T Наличие на складе: Невозможна поставка. Описание: The second edition of the best-selling practical guide to pharmaceutical analytics has been completely redesigned to take account of the Quality by Design (QbD) concept that has become the gold standard in pharmaceutical manufacturing. Two real-life case studies are included.
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: Pandey, Ravindra Kumar (associate Professor, Department Of Natural Products, Columbia Institute Of Pharmacy, India) Shukla, Shiv Shankar (associate Pr Название: Fingerprinting analysis and quality control methods of herbal medicines ISBN: 1138036943 ISBN-13(EAN): 9781138036949 Издательство: Taylor&Francis Рейтинг: Цена: 117390.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing the quality of herbal medicines. Fingerprinting has emerged as a suitable technique for quality estimation. Chemical markers are used for evaluation of herbal medicines. Identification and quantification of these chemical markers are crucial for quality control of herbal medicines. This book provides updated knowledge on methodology, quality assessment, toxicity analysis and medicinal values of natural compounds.
Автор: Ozkan, Sibel Название: Ozkan-New Developments in Nan. in Pharmaceutical Analysis ISBN: 0128161442 ISBN-13(EAN): 9780128161449 Издательство: Elsevier Science Рейтинг: Цена: 129130.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
New Developments in Nanosensors in Pharmaceutical Analysis presents an overview of developments in nanosensor usage in pharmaceutical analysis, thereby helping pharmaceutical companies attain reliable, precise, and accurate analysis of pharmaceuticals.
This book presents very simple, precise, sensitive, selective, fast, and relatively inexpensive methods for pre-treatment, prior to analysis. These methods may be considered for further application in clinical studies and assays. The book includes the manufacturing of sensors for pharmaceutical analysis at nano- or smaller scales, and gives simple and relatable designs for the fabrication of sensors. Twelve chapters cover an introduction to the topic, immobilization techniques, mechanism effect of nanomaterials on structure, optical nanosensors for pharmaceutical detection, chemical nanosensors in pharmaceutical analysis, noble metal nanoparticles in electrochemical analysis of drugs, photo-electrochemical nanosensors for drug analysis, molecularly imprinted polymer based nanosensors for pharmaceutical analysis, nanomaterials for drug delivery systems, nanomaterials enriched nucleic acid-based biosensors, nanosensors in biomarker detection, and nanomaterials-based enzyme biosensors for electrochemical applications.
Presents nanosensor types, synthesis, immobilizations and applications in different fields
Gives simple repeatable designs for the fabrication of sensors for pharmaceutical analysis
Details how to carry out sensitive analysis of pharmaceuticals using nanosensors
Describes how to synthesize and immobilize nanosensors, and how nanosensors can be applied in drug assay
Proposes innovative ways to optimize pharmaceutical processes with nanosensors
Автор: Bond Andrew Название: Pharmaceutical Crystallography: A Guide to Structure and Analysis ISBN: 1782629661 ISBN-13(EAN): 9781782629665 Издательство: Royal Society of Chemistry Рейтинг: Цена: 63360.00 T Наличие на складе: Невозможна поставка. Описание: Taking an intuitive and informal approach to solid-state structure and crystallographic concepts, this book is written for anyone who needs a clear understanding of modern crystallography
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