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Elsevier

Books in Pharmaceutical analysis

Focusing on analytical techniques such as chromatography, spectroscopy, and mass spectrometry, this portfolio supports chemists, quality control specialists, and researchers. It features new methodologies, validation procedures, and regulatory standards essential for ensuring drug purity, potency, and safety.

  • Physico-Chemical Aspects of Dosage Forms and Biopharmaceutics

    Recent and Future Trends in Pharmaceutics, Volume 2
    • 1st Edition
    • Amit Kumar Nayak + 1 more
    • English
    Physico-Chemical Aspects of Dosage Forms and Biopharmaceutics: Recent and Future Trends in Pharmaceutics, Volume Two explores aspects of pharmaceutics with an original approach that focuses on technology, novelties and future trends. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. Readers will find practical information for conducting research in pharmaceutics that is ideal for researchers in academia and industry as well as advanced graduate students in pharmaceutics.In addition, the book discusses the most recent developments in biopharmaceutics, including important and exciting areas such as solubility of drugs, pharmaceutical granulation, routes of drug administration, drug absorption, bioavailability and bioequivalence.

  • Novel Formulations and Future Trends

    Recent and Future Trends in Pharmaceutics, Volume 3
    • 1st Edition
    • Amit Kumar Nayak + 1 more
    • English
    Novel Formulations and Future Trends, Volume Three in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics with an original approach focused on technology, novelties and future trends. It discusses the most important developments in drug delivery, including important and exciting areas such as mucosal, implantable, transdermal, gastroretentive, vaccine and targeted drug delivery systems. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students.New technologies are also explored including 3D printing and computational pharmaceutics.

  • Designer Drugs

    Chemistry, Analysis, Regulation, Toxicology, Epidemiology & Legislation of New Psychoactive Substances
    • 1st Edition
    • Roy Gerona
    • English
    A title in the Emerging Issues in Analytical Chemistry series, Designer Drugs: Chemistry, Analysis, Regulation, Toxicology, Epidemiology & Legislation of New Psychoactive Substances presents both an overview and a guide to techniques for designer drug analysis. Proliferation of the synthesis and use of designer drugs is a serious public health problem with social, economic, and legal implications. Whether abuse is studied at the population level or the individual level, researchers need both background and highly detailed technical information on specific drugs and drug classes in order to combat the proliferation and highly damaging consequences of these substances. Author Roy Gerona provides a comprehensive discussion that emphasizes the potential threat to society, presents the ongoing challenges confronting the various laboratory approaches to detection and identification of new chemical entities, and informs the development of improved analytical solutions for use in legislation, law enforcement, and treatment.Designer Drugs: Chemistry, Analysis, Regulation, Toxicology, Epidemiology & Legislation of New Psychoactive Substances offers an introduction to the field and a source of information on specific drugs, drug effects, and analytical tools to a wide audience for anyone studying or engaging in designer drug analysis. Analytical and medical chemists, pharmacologist, toxicologists, and students, researchers, and policy makers in the fields of drug abuse, medicine, public health, and forensics will greatly benefit from this essential text.

  • Microneedles

    • 1st Edition
    • Kevin Ita
    • English
    Microneedles explores the design, fabrication and use of microneedles for drug and vaccine delivery. This book discusses the contemporary status of the field, describing several areas in detail, including the distinct types of microneedles (dissolving, solid, coted, hollow and hydrogel-forming). The anatomy of the eye is also described to facilitate an understanding of microneedle-assisted ocular drug delivery. Finally, the book provides a detailed discussion of microneedle use in the field of diagnostics, with a chapter dedicated to the mathematical modeling of microneedle-mediated drug delivery. As microneedles can be used by research scientists in academia and in industry, this book will be ideal for regulatory scientists and graduate students who find the topic relevant to their area of study.

  • The Detection of Biomarkers

    Past, Present, and the Future Prospects
    • 1st Edition
    • Sibel A. Ozkan + 2 more
    • English
    Reliable, precise and accurate detection and analysis of biomarkers remains a significant challenge for clinical　researchers... Methods for the detection of biomarkers are rather complex, requiring pre-treatment steps before analysis can take place. Moreover, comparing various biomarker assays and tracing research progress in this area systematically is a challenge for researchers. The Detection of Biomarkers presents developments in biomarker detection, including methods tools and strategies, biosensor design, materials, and applications. The book presents methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical, and therefore highly practical for use in clinical research scenarios. This volume situates biomarker detection in its research context and sets out future prospects for the area. Its 20 chapters offer a comprehensive coverage of biomarkers, including progress on nanotechnology, biosensor types, synthesis, immobilization, and applications in various fields. The book also demonstrates, for students, how to synthesize and immobilize biosensors for biomarker assay. It offers researchers real alternative and innovative ways to think about the field of biomarker detection, increasing the reliability, precision and accuracy of biomarker detection.

  • A Mechanistic Approach to Medicines for Tuberculosis Nanotherapy

    • 1st Edition
    • Mariappan Rajan
    • English
    A Mechanistic Approach to Medicines for Tuberculosis Nanotherapy examines drug carrier development for controlled, targeted, pH and stimuli responsive drug releases for tuberculosis. The book provides in-depth information about mycobacterium tuberculosis, tuberculosis formation, and synthetic procedures for carrier synthesis, characterizations and mechanistic approaches. Key topics include the properties and functions of nanomedicines and how they might be applied for clinical diagnosis and treatment. Emphasis is placed on the basic fundamentals, biomaterial formulations, design principles, fabrication techniques, and transitioning bench-to-bed clinical applications. This book is useful for new researchers who focus on nanomedicine, stem cell therapy and bone tissue engineering. In addition, it introduces experienced researchers and clinicians to key trends, thus increasing their knowledge in drug discovery for tuberculosis and nanomedicine.

  • Pharmacy Practice Research Case Studies

    • 1st Edition
    • Zaheer-Ud-Din Babar
    • English
    Pharmacy Practice Research Case Studies provides examples and details regarding how pharmacy practice research has transformed over the past decade and how this is impacting overall health. This book presents several methodologies and techniques used in current pharmacy practice. According to the United Nations Sustainable Development Goals, countries around the world are aiming to achieve Universal Health Coverage. In this context, pharmacists are a vital part of the healthcare teams and the book portrays the research methods used in conducting pharmacy practice and medicines use research. The professional role of pharmacists has evolved tremendously over the past few decades across the globe and the pace of change has been interestingly phenomenal in varying aspects. The book provides a great resource for pharmacists, pharmaceutical scientists, policymakers, and researchers to understand the dimensions of practice, education, research, and policy concerning pharmacy, and it provides the synthesis of the development so far, pointing to the needs and demands of the future.

  • Handbook of Analytical Quality by Design

    • 1st Edition
    • Sarwar Beg + 3 more
    • English
    Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields.

  • Accelerated Predictive Stability (APS)

    Fundamentals and Pharmaceutical Industry Practices
    • 1st Edition
    • Fenghe Qiu + 1 more
    • English
    Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly.

  • Profiles of Drug Substances, Excipients, and Related Methodology

    • 1st Edition
    • Volume 42
    • English
    Profiles of Drug Substances, Excipients, and Related Methodology, Volume 42 presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients, thus meeting the needs of the pharmaceutical community and allowing for the development of a timely vehicle for publishing review materials on the topic. This latest release covers a variety of substances, including Cinacalcet Hydrochloride, Clenbuterol Hydrochloride, Gliclazide, Lomefloxacin, Olmesartan, Propranolol, and Tolterodine Tartrate. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories, Physical profiles of drug substances and excipients, Analytical profiles of drug substances and excipients, Drug metabolism and pharmacokinetic profiles of drug substances and excipients, Methodology related to the characterization of drug substances and excipients, Methods of chemical synthesis, and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Dynemicin A, Uncialamycin and Analogues

    • 1st Edition
    • Daniel Best + 2 more
    • English
    Enediynes are natural products with highly active cytotoxicity and antibacterial activity, and thus have significant potential in the development of anti-cancer treatments. However, they are not readily available and can degrade rapidly during isolation; one solution is to produce them using total synthesis.Dynemicin A and uncialamycin are two such enediynes, with similar structures, for which total synthesis has been achieved. This book presents the isolation and preparation of these two compounds and their analogues through various synthesis strategies. Details of the structural elements essential to their anti-cancer activity are presented, with the objective of explaining and optimizing their biological activities and potential development as drugs.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 41
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Marine Carbohydrates: Fundamentals and Applications, Part B

    • 1st Edition
    • Volume 73
    • English
    Marine Carbohydrates: Fundamentals and Applications brings together the diverse range of research in this important area which leads to clinical and industrialized products. The volume, number 73, focuses on marine carbohydrates in isolation, biological, and biomedical applications and provides the latest trends and developments on marine carbohydrates. Advances in Food and Nutrition Research recognizes the integral relationship between the food and nutritional sciences and brings together outstanding and comprehensive reviews that highlight this relationship. Volumes provide those in academia and industry with the latest information on emerging research in these constantly evolving sciences.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 39
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Profiles of Drug Substances, Excipients, and Related Methodology

    • 1st Edition
    • Volume 38
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 36
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Handbook of Modern Pharmaceutical Analysis

    • 2nd Edition
    • Volume 10
    • Satinder Ahuja + 1 more
    • English
    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.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 35
    • Harry G. Brittain
    • English
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Capillary Electrophoresis Methods for Pharmaceutical Analysis

    • 1st Edition
    • Volume 9
    • Satinder Ahuja + 1 more
    • English
    Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control.

  • Handbook of Pharmaceutical Analysis by HPLC

    • 1st Edition
    • Volume 6
    • Satinder Ahuja + 1 more
    • English
    High pressure liquid chromatography–frequ... 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).

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 30
    • English
    Whilst following in the footsteps of previous volumes by presenting comprehensive reviews of drug substances and additional materials, this title also heralds a significant expansion of the scope of the series. Traditional contributions will now also be augmented by publication of critical review chapters that summarize information related to the characterization of drug substances and excipients. This change is required to better meet the needs of the pharmaceutical communtiy and to allow the development of a timely vehicle for publishing review materials on this topic.The scope of the Profiles series will encompass review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodologoy related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

    • 1st Edition
    • Volume 5
    • Satinder Ahuja + 1 more
    • English
    The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.

  • Analytical Profiles of Drug Substances and Excipients

    • 1st Edition
    • Volume 28
    • English
    Although the official compendia define a drug substance by its identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories.Edited by the Associate Director of Analytical Research and Development for the American Association of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together in one source. The scope of the series has recently been expanded to include profiles of excipient materials.

  • Handbook of Modern Pharmaceutical Analysis

    • 1st Edition
    • Volume 3
    • Satinder Ahuja + 1 more
    • English
    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.

  • Analytical Profiles of Drug Substances and Excipients

    • 1st Edition
    • Volume 27
    • English
    Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories.Edited by the Associate Director of Analytical Research and Development for the American Association of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together in one source. The scope of the series has recently been expanded to include profiles of excipient materials.

  • Analytical Profiles of Drug Substances and Excipients

    • 1st Edition
    • Volume 26
    • English
    Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the American Association of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.

  • Analytical Profiles of Drug Substances and Excipients

    • 1st Edition
    • Volume 25
    • English
    Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the American Association of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.