Novel Developments in Pharmaceutical and Biomedical Analysis - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Novel Developments in Pharmaceutical and Biomedical Analysis write by Atta-ur- Rahman. This book was released on 2018-04-24. Novel Developments in Pharmaceutical and Biomedical Analysis available in PDF, EPUB and Kindle. Recent Advances in Analytical Techniques is a series of updates in techniques used in chemical analysis. Each volume presents information about a selection of analytical techniques. Readers will find information about developments in analytical methods such as chromatography, electrochemistry, optical sensor arrays for pharmaceutical and biomedical analysis. Novel Developments in Pharmaceutical and Biomedical Analysis is the second volume of the series and covers the following topics: o Chromatographic assays of solid dosage forms and their drug dissolution studies o UHPLC method for the estimation of bioactive compounds o HILIC based LC/MS for metabolite analysis o In vitro methods for the evaluation of oxidative stress o Application of vibrational spectroscopy in studies of structural polymorphism of drugs o Electrochemical sensors based on conductive polymers and carbon nanotubes o Optical sensor arrays for pharmaceutical and biomedical analyses o Chemical applications of ionic liquids o New trends in enantioanalysis of pharmaceutical compounds
Development and Validation of Analytical Methods
Development and Validation of Analytical Methods - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Development and Validation of Analytical Methods write by Christopher M. Riley. This book was released on 1996-05-29. Development and Validation of Analytical Methods available in PDF, EPUB and Kindle. The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
High Throughput Bioanalytical Sample Preparation
High Throughput Bioanalytical Sample Preparation - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook High Throughput Bioanalytical Sample Preparation write by David A. Wells. This book was released on 2003-01-28. High Throughput Bioanalytical Sample Preparation available in PDF, EPUB and Kindle. High Throughput Bioanalytical Sample Preparation: Methods and Automation Strategies is an authoritative reference on the current state-of-the-art in sample preparation techniques for bioanalysis. This book focuses on high throughput (rapid productivity) techniques and describes exactly how to perform and automate these methodologies, including useful strategies for method development and optimization. A thorough review of the literature is included within each of these chapters describing high throughput sample preparation techniques: protein removal by precipitation; equilibrium dialysis and ultrafiltration; liquid-liquid extraction; solid-phase extraction; and various on-line techniques. The text begins with an introductory overview of the role of bioanalysis in pharmaceutical drug development. Fundamental understanding of the strategies for sample preparation is reinforced next, along with essential concepts in extraction chemistry. Several chapters introduce and discuss microplates, accessory products and automation devices. Particular strategies for efficient use of automation within a bioanalytical laboratory are also presented. The subject material then reviews protein precipitation, liquid-liquid extraction, solid-phase extraction and various on-line sample preparation approaches. The book concludes with information on recent advances in sample preparation, such as solid-phase extraction in a card format and higher density extraction plates. Important objectives that can be accomplished when the strategies presented in this book are followed include: improved efficiency in moving discovery compounds to preclinical status with robust analytical methods; return on investment in automation for sample preparation; and improved knowledge and expertise of laboratory staff. · Shows the reader exactly how to perform modern bioanalytical sample preparation techniques, complete with detailed strategies · Thorough literature review and summary of published information · Detailed discussion and examples of the method development process
Pharmaceutical Analysis E-Book
Pharmaceutical Analysis E-Book - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Pharmaceutical Analysis E-Book write by David G. Watson. This book was released on 2015-12-24. Pharmaceutical Analysis E-Book available in PDF, EPUB and Kindle. Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of chemical, physical and microbiological analyses. It is reckoned that over £10 billion is spent annually in the UK alone on pharmaceutical analysis, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. This is the key textbook in pharmaceutical analysis, now revised and updated for its fourth edition. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on Biotech products. New chapter on electrochemical methods in diagnostics. Greatly extended chapter on molecular emission spectroscopy to accommodate developments and innovations in the area. Now on StudentConsult
Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences
Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences write by Andrei A. Bunaciu. This book was released on 2020-07-26. Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences available in PDF, EPUB and Kindle. Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences synthesizes the latest research on the applications of vibrational spectroscopy in biomedical, pharmaceutical and food analysis. Suitable for graduate-level students as well as experienced researchers in academia and industry, this book is organized into five distinct sections. The first deals with the fundamentals of vibrational spectroscopy, with the second presenting the most important sampling methodology used for infrared and Raman spectroscopy in various fields of interest. Since spectroscopy is the study of the interaction of electromagnetic radiation with matter, this section deals with the characteristics, properties and absorption of electromagnetic radiation. Final sections describe the analytical studies performed all over the world in biomedical, pharmaceutical and in the food sciences. - Presents a critical discussion of many of the applications of vibrational spectroscopy - Covers details of the analytical methodologies used in pharmaceutical and biomedical applications - Discusses the latest developments in pharmaceutical and biomedical analysis of both small and large molecules
