Download or read book Development of Analytical Methods for the Determination of Drug Substances in Biological Fluids written by E. T. Lin and published by . This book was released on 1983 with total page 21 pages. Available in PDF, EPUB and Kindle. Book excerpt: A high performance liquid chromatographic (HPLC) procedure for the analysis of pyridostigmine in plasma has been developed. Only 0.5 ml of plasma is required for the analysis. The clean-up procedure involves a protein precipitation step and a column elution step prior to separation by HPLC. The assay is quite sensitive, with a detection limit of 2 ng/ml for pyridostigmine bromide in plasma. Assay precision was evaluated from blind samples in the range of 0 - 50 ng/ml and the difference was 8 to 12%. Stability was also determined for pyridostigmine in plasma at -20 C and -80 C. The results showed no degradation for pyridostigmine at -80 C for up to two months. In a preliminary study with one human volunteer, the drug was detected up to 8 hours following oral doses of syrup solution of 0.4 to 0.9 mg/kg. This assay is suitable for pharmacokinetic studies involving pyridostigmine in human subjects.
Download or read book The Analysis of Drugs in Biological Fluids written by Joseph Chamberlain and published by CRC Press. This book was released on 2018-02-06 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition focuses on a variety of techniques available for the analysis of drugs in biological fluids. Over 150 figures and tables help to describe the latest advances and give examples of their applications. Current chiral analysis methods as well as discussions on the impact of chirality are described. Practical aspects of bioanalytical work, including many examples of laboratory problems not often reported in the scientific literature, are examined in depth.
Download or read book Handbook of Drug Monitoring Methods written by Amitava Dasgupta and published by Springer Science & Business Media. This book was released on 2007-10-23 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a handbook style with specific methods and tips on eliminating false positive and false negative results, this book is a practical guide to the detailed mechanisms of such occurrences.
Download or read book Introduction to Pharmaceutical Chemical Analysis written by Steen Hansen and published by John Wiley & Sons. This book was released on 2011-12-12 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples
Download or read book Development of Analytical Methods for Determination of Drugs Used Against Tropical Diseases in Biological Fluids written by and published by . This book was released on 2006 with total page 33 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Analytical Techniques for Clinical Chemistry written by Sergio Caroli and published by John Wiley & Sons. This book was released on 2012-06-26 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover how analytical chemistry supports the latest clinical research This book details the role played by analytical chemistry in fostering clinical research. Readers will discover how a broad range of analytical techniques support all phases of clinical research, from early stages to the implementation of practical applications. Moreover, the contributing authors' careful step-by-step guidance enables readers to better understand standardized techniques and steer clear of everyday problems that can arise in the lab. Analytical Techniques for Clinical Chemistry opens with an overview of the legal and regulatory framework governing clinical lab analysis. Next, it details the latest progress in instrumentation and applications in such fields as biomonitoring, diagnostics, food quality, biomarkers, pharmaceuticals, and forensics. Comprised of twenty-five chapters divided into three sections exploring Fundamentals, Selected Applications, and Future Trends, the book covers such critical topics as: Uncertainty in clinical chemistry measurements Metal toxicology in clinical, forensic, and chemical pathology Role of analytical chemistry in the safety of drug therapy Atomic spectrometric techniques for the analysis of clinical samples Biosensors for drug analysis Use of X-ray techniques in medical research Each chapter is written by one or more leading pioneers and experts in analytical chemistry. Contributions are based on a thorough review and analysis of the current literature as well as the authors' own firsthand experiences in the lab. References at the end of each chapter serve as a gateway to the literature, enabling readers to explore individual topics in greater depth. Presenting the latest achievements and challenges in the field, Analytical Techniques for Clinical Chemistry sets the foundation for future advances in laboratory research techniques.
Download or read book Pharmaceutical Analysis written by David C Lee and published by John Wiley & Sons. This book was released on 2009-02-12 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of analytical sciences in the discovery, development andmanufacture of pharmaceuticals is wide-ranging. From the analysisof minute amounts of complex biological materials to the qualitycontrol of the final dosage form, the use of analytical technologycovers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drugdevelopment and manufacture, focusing on the analysis of the activeingredient or drug substance. It provides those joining theindustry or other areas of pharmaceutical research with a source ofreference to a broad range of techniques and their applications,allowing them to choose the most appropriate analytical techniquefor a particular purpose. The volume is directed at analytical chemists, industrialpharmacists, organic chemists, pharmaceutical chemists andbiochemists.
Download or read book Bioanalysis of Pharmaceuticals written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications. It discusses the chemical structures and properties of low- and high-molecular drug substances; the different types of biological samples and fluids that are used; how to prepare the samples by extraction, and how to perform the appropriate analytical measurements by chromatographic and mass spectrometric methods. Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry: Is an introductory student textbook discussing the different principles and concepts clearly and comprehensively, with many relevant and educational examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents both the basic principles that are regularly taught in universities, along with the practical use of bioanalysis as carried out by researchers in the pharmaceutical industry and in hospital laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The book includes multiple examples to illustrate the theory and application, with many practical aspects including calculations, thus helping the student to learn how to convert the data recorded by instruments into the real concentration of the drug substances within the biological sample.
Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2020-07-23 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. - Presents a critical assessment of the application of ICH guidelines on method validation and specification setting - Written by subject-matter experts involved in the development and application of the guidelines - Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products - Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Download or read book Analytical Method Development by Liquid Chromatography written by Prafulla Kumar Sahu and published by LAP Lambert Academic Publishing. This book was released on 2011-10 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The current good manufacturing practice (cGMP) and Food Drug Administration (FDA) Guidelines insist for adoption of sound methods of analysis with greater sensitivity and reproducibility. This thesis describes analytical methods developed for drug determination in pharmaceutical dosage forms and biological matrixes including Chromatography (RP-HPLC) and Hyphenated Techniques (LC-MS/MS). Methods have been developed for separation and quantification of selected drugs from categories like Antihypertensive, Antihyperlipidemic, Skeletal Muscle Relaxant, Non-Steroidal Anti-inflammatory Drug (NSAID), Antibiotic, Anticonvulsant, Antiviral, and Analeptic.
Download or read book Analysis of Investigational Drugs in Biological Fluids Method Development and Routine Assay written by Emil T. Lin and published by . This book was released on 1987 with total page 15 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report describes the status of method developement and routine analytical work. The purpose of this work is to develop and routinely use analytical methods for the determination of the concentration in biological specimens of investigational drugs in support of pharmacokinetic and bioavailability studies undertaken for the purpose of new drug development for the US military establishment. Accepted scientific procedures including normal and reversed phase high-performance liquid chromatographic methods, post column derivatization, and protein precipitation and cartridge elution sample clean up procedures were employed in development and routine work. Six methodologies (for the assay of samples for WR 2721 in plasma, WR 3689 in plasma, pyridostigmine in urine, mefloquine in plasma, physostigmine in plasma and WR 6026 in blood) are currently under development, three routine analyses(for determination of the concentrations of pyridostigmine in urine, WR 6026 in plasma, and halofantrine in plasma) have been performed in support of bioavailability and pharmacokinetic studies, and routine analyses (for mefloquine in plasma and pyridostigmine in plasma) are in progress in support of other studies.
Download or read book HPLC Methods for Recently Approved Pharmaceuticals written by George Lunn and published by John Wiley & Sons. This book was released on 2005-05-06 with total page 743 pages. Available in PDF, EPUB and Kindle. Book excerpt: An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library. Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceutical compounds * Various procedures for each drug listed together-making it easy to mix and match for customized approaches * Methods for drugs in biological fluids and for bulk and formulated drugs * Chemical structures, molecular weights and formulas, and CAS Registry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the same methods
Download or read book Analytical Methods for Therapeutic Drug Monitoring and Toxicology written by Q. Alan Xu and published by John Wiley & Sons. This book was released on 2011-04-12 with total page 913 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a compilation of summarized analytical methods designed to serve the needs of pharmacologists, toxicologists, and other allied health professionals involved the development, use, or monitoring of pharmaceuticals. The summaries are structured monographs on 511 different drug entities detailing 964 different analytical methods, providing the reader with a thorough description of method validation. These analytical methods include not only high performance liquid chromatography (HPLC), but also gas chromatography (GC), immunoassay, electrophoresis, ultra performance liquid chromatography (UPLC) coupled with UV (UPLC-UV) detection and mass spectrometry (UPLC-MS/MS). With more detailed and complete summaries than sketchy and abbreviated formats used in the other books, this book provides a thorough description of method validation and results, as well as the operating parameters.
Download or read book Pharmaceutical and Biomedical Applications of Liquid Chromatography written by W.J. Lough and published by Newnes. This book was released on 2013-10-22 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume reflects the changes that have taken place in the pharmaceutical industry over the last ten years, most notably the increased importance attached to the question of chirality, the growing influence of biotechnology and the need for more rigorous documentation and validation of analytical methods and procedures. The first part of this book deals with the application of new technology to pharmaceutical and biomedical analysis, reflecting the present needs for increased speed, sensitivity and selectivity in the analysis of drugs. The second chapter provides an overview of capillary electophoresis, which represents one of the most inportant analytical developments to impact directly on pharmaceutical development in recent years. Although not a chromatographic technique, capillary electrophoresis was considered too important to be ignored. Over the last 25 years, liquid chromatography has grown into a mature analytical technique and many of the fundamental issues concerned with retention and separation are well defined. The practitioners of modern liquid chromatography spend as much time in the development of techniques for sampling handling and automation as they do in the development of the separation. Therefore, Part Two of this book describes some of the recent advances in the areas of sample handling and the isolation of compounds from biological samples, including solid phase extraction, restricted access media for direct injection, coupled column technology and microdialysis. Similarily, Part Three contains two chapters concerned with liquid chromatographic methods for the isolation of drug substances, peptides and proteins from other complex media. The pharmaceutical industry and the process of drug development are highly regulated and the increasing importance that the regulatory authorities attach to validation has had a significant impact on the analytical techniques used for the analysis of drugs. Although this has increased the workload of analysts in the pharmaceutical industry, it has also improved the quality of analytical methods used in the support of investigational and new drug applications as well as the quality of methods published more recently in the literature. Consequently, Part Four of this volume describes approaches to the optimization and validation of liquid chromatography methods for the analysis of drugs in the bulk form, in pharmaceutical formulations and biological fluids.
Download or read book NMR Spectroscopy in Drug Development and Analysis written by Ulrike Holzgrabe and published by John Wiley & Sons. This book was released on 2008-07-11 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the development of the NMR spectrometer in the 1950s, NMR spectra have been widely used for the elucidation of the 2D structure of newly synthesized and natural compounds. In the 1980s, the high-resolution NMR spectrometer (> 300 Mhz) and 2D experiments were introduced, which opens up the possibility to determine the 3D structure of large molecules, especially biomolecules. However, NMR spectroscopy has been rarely applied to drug analysis. This book illustrates the power and versatility of NMR spectroscopy in the determination of impurities in and the content of drugs, the composition of polymer excipients, the characterization of isomeric drug mixtures, the complexity of drugs with small-size components or ions, and the behavior of drugs in acid and basic solution. In addition, NMR spectroscopy and especially the hyphenated technique with HPLC is shown to be a powerful tool to measure a drug and its metabolites in various body fluids. The solid state NMR technique can give information on the structure, especially the conformation of drugs and excipients in drug formulations. Recently, SAR by NMR, introduced by Fesik, impressively demonstrated the potential of NMR spectroscopy in drug development and in the characterization of the interaction between large molecules and ligands. The complexation between proteins, lipids and cyclodextrins with drugs is described. Finally, NMR imaging (MRI and MRS) can be used to characterize the liberation of drugs from a drug formulation. Furthermore, the distribution of substances in plants, in animals, in tissues and in humans can be visualized by imaging. In short, this book covers all aspects of drug analysis.
Download or read book Prof of Drug Substances Excipients and Related Methodology written by Abdulrahman Al-Majed and published by Academic Press. This book was released on 2021-01-16 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: Profiles of Drug Substances, Excipients, and Related Methodology, Volume 46 contains comprehensive profiles of five drug compounds: Darunavir, Bisoprolol, Betaxolol, Rabeprazole and Irbesartan. In addition, the work contains a chapter reviewing Bioassay Methods and Their Applications in Herbal Drug Research. The comprehensive reviews in the book cover all aspects of drug development and the formulation of drugs, helping readers understand how the drug development community remains essential to all phases of pharmaceutical development. In addition, this work answers why such profiles are of immeasurable importance to workers in the field. The scope of the Profiles series encompasses review articles and database compilations that fall within one or more of the following five broad categories: Physical Profiles of Drug Substances and Excipients, Analytical Profiles of Drug Substances and Excipients, ADME Profiles of Drug Substances and Excipients, Methodology Related to the Characterization of Drug Substances and Excipients, and Methods of Chemical Synthesis. - Contains contributions from leading authorities - Presents an excellent overview on the physical, chemical and biomedical properties of some regularly prescribed drugs - Includes a cumulative index in each volume
