Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis PDF Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780123759818
Category : Medical
Languages : en
Pages : 598

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Book Description
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis PDF Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780123759818
Category : Medical
Languages : en
Pages : 598

Get Book

Book Description
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis PDF Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780123756800
Category : Science
Languages : en
Pages : 582

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Book Description
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Handbook Of Modern Pharmaceutical Analysis (Hb)

Handbook Of Modern Pharmaceutical Analysis (Hb) PDF Author: Ahuja
Publisher:
ISBN: 9788181479815
Category :
Languages : en
Pages : 566

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Book Description


Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis PDF Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080488927
Category : Medical
Languages : en
Pages : 566

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Book Description
This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC PDF Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 9780080455181
Category : Medical
Languages : en
Pages : 600

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Book Description
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules PDF Author: Behnam Davani
Publisher: John Wiley & Sons
ISBN: 1119425018
Category : Science
Languages : en
Pages : 256

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Book Description
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.

Handbook of Regression and Modeling

Handbook of Regression and Modeling PDF Author: Daryl S. Paulson
Publisher: CRC Press
ISBN: 1420017381
Category : Mathematics
Languages : en
Pages : 520

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Book Description
Carefully designed for use by clinical and pharmaceutical researchers and scientists, Handbook of Regression Analysis and Modeling explores statistical methods that have been adapted into biological applications for the quickly evolving field of biostatistics. The author clearly delineates a six-step method for hypothesis testing using data that mimics real life. Relying heavily on computer software, he includes exploratory data analysis to evaluate the fit of the model to the actual data. The book presents a well-defined procedure for adding or subtracting independent variables to the model variable and covers how to apply statistical forecasting methods to the serially correlated data characteristically found in clinical and pharmaceutical settings. The stand alone chapters allow you to pick and choose which chapter to read first and home in on the information that fits your immediate needs. Each example is presented in computer software format. The author uses MINITAB in the book but supplies instructions for SAS and SPSSX, making the book easily adaptable to individual situations. Although written with the assumption that the reader has knowledge of basic and matrix algebra, the book supplies a short course on matrix algebra in the appendix for those who need it. Covering more than just statistical theory, the book provides advanced methods that you can put to immediate use.

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES

MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES PDF Author: Dr. Venkata Suresh Jilakara , Dr. Har Govind Garg, Mr. P. S. Minhas , Mrs. Bhanupriya Bhrigu , Dr. Anuja Chopra
Publisher: Shashwat Publication
ISBN: 936087048X
Category : Medical
Languages : en
Pages : 412

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Book Description
In the ever-evolving landscape of pharmaceutical sciences, the role of analytical techniques cannot be overstated. The quality, safety, and efficacy of pharmaceutical products hinge upon the precision and reliability of analytical methods employed throughout their development, manufacturing, and regulatory approval processes. The past few decades have witnessed remarkable strides in analytical instrumentation, methodologies, and data analysis, catalyzing a paradigm shift in pharmaceutical analytics. This book is conceived as a comprehensive guide to modern pharmaceutical analytical techniques, aiming to bridge the gap between theoretical knowledge and practical application in the dynamic pharmaceutical industry. It is designed to serve as an invaluable resource for students, researchers, and professionals engaged in pharmaceutical analysis, providing a systematic overview of the state-of-the-art analytical tools and strategies employed in drug discovery, development, and quality control. Each chapter is meticulously crafted to deliver comprehensive insights into the theoretical foundations, practical considerations, and recent advances pertinent to the respective analytical technique, supplemented with illustrative examples, case studies, and critical discussions. Moreover, special attention is devoted to emerging trends, such as nanotechnology-enabled analytical platforms, microfluidic-based assays, and in silico predictive modeling, underscoring the transformative potential of cutting-edge technologies in reshaping the landscape of pharmaceutical analytics. It is our fervent hope that this book will serve as a catalyst for fostering interdisciplinary collaboration, driving innovation, and advancing best practices in pharmaceutical analytical sciences. We extend our sincere gratitude to the contributors for their scholarly contributions and dedication, as well as to the readers for their interest and engagement in this endeavor.

Handbook of Analysis of Oligonucleotides and Related Products

Handbook of Analysis of Oligonucleotides and Related Products PDF Author: Jose V. Bonilla
Publisher: CRC Press
ISBN: 1439819947
Category : Medical
Languages : en
Pages : 502

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Book Description
Oligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders. The Handbook of Analysis of Oligonucleotides and Related Products is an essen

Handbook of Pharmaceutical Analysis

Handbook of Pharmaceutical Analysis PDF Author: Lena Ohannesian
Publisher: CRC Press
ISBN: 0824741943
Category : Medical
Languages : en
Pages : 605

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Book Description
Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.