This book gives an overview of therapeutic drug monitoring (TDM) and its clinical application. It also highlights recent advances in toxicological studies, as they relate to therapeutic drug monitoring. This is one of the few books available on the market that covers TDM. Therapeutic drug monitoring (TDM) is a clinical decision-making tool that enables dosage regimen adjustments based on clinical and laboratory measurements. TDM not only involves the measuring of drug concentrations but also interpretation of the results. There is a strong correlation between drug concentrations in body fluids and outcome than between dose and outcome. The chapters include coverage of analytical techniques, pharmacokinetics, therapeutic indices, artificial intelligence and recent advances in toxicological studies. The book fills a gap in published literature and provides reliable information on; Analytical techniques in TDM and clinical toxicology TDM and pharmacokinetic studies TDM of drugs with narrow therapeutic indices Artificial intelligence in TDM and clinical toxicology Future directions and challenges

This book illustrates the importance of the Natural Biometabolites, which offer a rich reservoir of candidate compounds for drug discovery in the battle against cancer. Recent research and development efforts concerning anti-cancer drugs derived from natural products have led to the identification of numerous candidate molecules that inhibit cancer cell proliferation and metastasis using a variety of mechanisms. Given its scope, the book offers a valuable resource for cancer biologists and general oncologists alike, while also benefitting research professionals in Science, Nursing, Medicine, Biochemistry, Genetics and Bioscience who wish to understand the fundamentals of prognosis and prediction in tumorigenesis. Moreover, the book provides an essential platform for understanding drug resistance mechanisms and combatting the growing menace of multidrug resistance.

This book focuses on the different compounds (polyphenols, sterols, alkaloids terpenes) that arise from the secondary metabolism of plants and fungi and their importance for research and industry. These compounds have been the backbone and inspiration of various industries like the food, pharmaceutical and others to produce synthetic counterparts. Furthermore, many of these compounds are still widely used to carry out specific functions in all these industries. This book offers a compilation of different texts from world leading scientists in the areas of chemistry, biochemistry, plant science, biotechnology which compile information on each group of secondary metabolism compounds, and their most important applications in the food, pharmaceutical, cosmetic and textile industry. By showcasing the best uses of these compounds, the chemistry behind their production in plants and fungi, this book is a valuable resource and a "go to" artifact for various audiences. The new approach this book offers, by linking research and the application of these compounds, makes it interesting as an inspiration for new research or as a hallmark of what has been done in the secondary metabolism of plants and fungi in recent years. Although this book may be technical, it is also enjoyable as an integral reading experience due to a structured and integrated flow, from the origins of secondary metabolism in organisms, to the discovery of their effects, their high intensity research in recent years and translation into various industries. Beyond learning more on their chemistry, synthesis, metabolic pathway, readers will understand their importance to different research and industry.

Introducing the most recent advances in crystallography, nuclear magnetic resonance, molecular modeling techniques, and computational combinatorial chemistry, this unique, interdisciplinary reference explains the application of three-dimensional structural information in the design of pharmaceutical drugs. Furnishing authoritative analyses by world-renowned experts, Structure-Based Drug Design discusses protein structure-based design in optimizing HIV protease inhibitors and details the biochemical, genetic, and clinical data on HIV-1 reverse transcriptase presents recent results on the high-resolution three-dimensional structure of the catalytic core domain of HIV-1 integrase as a foundation for divergent combination therapy focuses on structure-based design strategies for uncovering receptor antagonists to treat inflammatory diseases demonstrates a systematic approach to the design of inhibitory compounds in cancer treatment reviews current knowledge on the Interleukin-1 (IL-1) system and progress in the development of IL-1 modulators describes the influence of structure-based methods in designing capsid-binding inhibitors for relief of the common cold and much more!

This book is intended for a broad readership, in particular, those working or interested in drug discovery coming from various disciplines such as medicinal chemistry, pharmacology, drug metabolism and pharmacokinetics, bioanalysis, clinical sciences, biochemistry, pharmaceutics, and toxicology. It provides, for the first time, a completely integrated look at multiple aspects of ADME sciences (absorption, distribution, metabolism, and excretion) in a summary format that is clear, concise, and self-explanatory. DMPK in Drug Discovery - Guide to Data Interpretation and integration leverages the prior knowledge from the first book that covers the basics of each concept (Drug Metabolism and Pharmacokinetics Quick Guide). This reference book is meant to be used day to day and provides many useful tables (used for data interpretation), figures, and case studies that can facilitate drug discovery. The case studies are intended to be short and relevant to the topic discussed and present another dimension to the discussions.

This volume contains the proceedings of the Eighth International Symposium on Cyclodextrins, held in Budapest, Hungary, March 31-April 2, 1996. The 147 papers collected here are milestones in the exponentially increasing cyclodextrin literature, and represent a summary of the last two years' achievement in this field, with applications in such diverse disciplines as pharmaceuticals, food, cosmetics, textiles, plastics, and chromatography. Some highlights: lipophilicity profiles of cyclodextrins by computer molecular graphics; recent toxicological studies on cyclodextrins; Buckminsterfullerene/cyclodextrin complexes; hydroxypropyl-beta-cyclodextrin; pharmacokinetics and toxicology; peracylated cyclodextrins as drug carriers; cyclodextrins in nasal drug delivery; textile fibre surface modification by a reactive cyclodextrin; cyclodextrin-containing fabric care products; drug targeting by cyclodextrin-dimers for photodynamic cancer therapy; cyclodextrins in ophthalmologic drugs; new cyclodextrin derivatives and their potentials. Audience: This book will be of interest to researchers whose work involves pharmaceuticals, food chemicals and flavours, food additives, chromatographic methods, and biotechnology, as well as fundamental cyclodextrin research.

Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.

This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter "SSA" or "Africa"). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime's inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.

Authored by leading experts from academia, users and manufacturers, this book provides an authoritative account of the science and technology involved in multiparticulate drug delivery systems which offer superior clinical and technical advantages over many other specialized approaches in drug delivery. The book will cover market trends, potential benefits and formulation challenges for various types of multiparticulate systems. Drug solubility, dose, chemistry and therapeutic indications as well as excipient suitability coupled with manufacturing methods will be fully covered. Key approaches for taste-masking, delayed release and extended release of multiparticulates systems are of significant interest, especially their in-vivo and in-vitro performance. In addition, the principles of scale-up, QbD, and regulatory aspects of common materials used in this technology will be explained, as well as recent advances in materials and equipment enabling robust, flexible and cost-effective manufacture. Case studies illustrating best practices will also make the book a valuable resource to pharmaceutical scientists in industry and academia.

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.

Cosmetics are the most widely applied products to the skin and include creams, lotions, gels and sprays. Their formulation, design and manufacturing ranges from large cosmetic houses to small private companies. This book covers the current science in the formulations of cosmetics applied to the skin. It includes basic formulation, skin science, advanced formulation, and cosmetic product development, including both descriptive and mechanistic content with an emphasis on practical aspects. Key Features: Covers cosmetic products/formulation from theory to practice Includes case studies to illustrate real-life formulation development and problem solving Offers a practical, user-friendly approach, relying on the work of recognized experts in the field Provides insights into the future directions in cosmetic product development Presents basic formulation, skin science, advanced formulation and cosmetic product development

This volume provides information on how to select and screen plants for their medicinal properties. It describes phytopharmacological techniques for extracting and qualitatively and quantitatively analyzing a plant's phytochemicals. After a detailed in vitro investigation including nutritional and anti-nutritional analyses, medicinal properties were tested with various in vivo models for anti-inflammatory, analgesic, anti-pyretic, anticancer and anti-diabetic properties, as well as wound healing, neurodegenerative diseases, etc. Compound identification and purification techniques include, among others, TLC and column chromatography, as well as molecular docking with specific proteins.

Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.

An established textbook that provides you with full coverage of the physicochemical principles essential to the modern pharmacist and pharmaceutical scientist. This sixth edition has a broad chemical and physicochemical base and covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body. Now with more clinical examples, new questions and extra case studies.

From the Authors' Preface The advances made in the area of controlled drug delivery during the last two decades are remarkable ....Of the many polymeric materials, biodegradable hydrogels present unique advantages and opportunities in the development of ...delivery devices....We have undertaken the challenge of putting together information relevant to biodegradable hydrogels in one place. This book covers the mechanisms of biodegradation, types of biodegradable hydrogels,chemical and physical gels, chemical and enzymatic degradation, and examples of biodegradable drug delivery systems.

A comprehensive treatment of the science, technology, and regulation of rate-controlled administration of therapeutic agents, with coverage of the basic concepts, fundamental principles, biomedical rationales, and potential applications. This revised and updated edition (first in 1982) incorporates

Introduction, Historical Highlights, and the Need for Dissolution Testing Theories of Dissolution Dissolution Testing Devices Automation in Dissolution Testing, by William A. Hanson and Albertha M. Paul Factors That Influence Dissolution Testing Interpretation of Dissolution Rate Data Techniques and of In Vivo Dissolution, by Umesh V. Banakar, Chetan D. Lathia, and John H. Wood Dissolution of Dosage Forms Dissolution of Modified-Release Dosage Forms Dissolution and Bioavailability Dissolution Testing and the Assessment of Bioavailability/Bioequivalence, by Santosh J. Vetticaden Dissolution Rediscovered, by John H. Wood Appendix: USP/NF Dissolution Test.

The first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation. It revises current classical paradigms in target and phenotypic-based drug design with still ingrained approximations and concepts and discusses the research in the new network approach concept that include kinetic selectivity and metabolic analysis. Many often-overlooked approximations and concepts in drug discovery are fully covered. Drug Target Selection and Validation includes both introductory sections and research-based sections to be of use to both students and research scientists in drug discovery, design, kinetics and metabolic analysis. Pharmaceutical scientists, pharmaceutics, drug developers, pharmacologists, biomedical researchers in computer science, medicinal chemists, and precision medicine developers benefit from the information provided. The book concludes with a chapter on chemical and structural databases.

Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs."

This book provides the pharmaceutical formulator with the fundamental understanding necessary to prepare efficacious topical drug delivery formulations that have both chemical and physical stability and that are cosmetically acceptable and preferably cosmetically elegant.

Combinatorial chemistry and molecular diversity approaches to scientific inquiry and novel product R&D have exploded in the 1990s! For example, in the preparation of drug candidates, the automated, permutational, and combinatorial use of chemical building blocks now allows the generation and screening of unprecedented numbers of compounds. Drug discovery - better, faster, cheaper? Indeed, more compounds have been made and screened in the 1990s than in the last hundred years of pharmaceutical research. This first volume covers: (i) combinatorial chemistry, (ii) combinatorial biology and evolution, and (iii) informatics and related topics. Within each section chapters are prepared by experts in the field, including, for example, in Section I: Coverage of mixture pools vs. parallel individual compound synthesis, solution vs. solid-phase synthesis, analytical tools, and automation. Section II highlights selection strategies and library-based evolution, phage display, peptide and nucleic acid libraries. Section III covers databases and library design, high through-put screening, coding strategies vs. deconvolutions, intellectual property issues, deals and collaborations, and successes to date.

The revised and up-to-date third edition of Drug Interactions in Infectious Diseases delivers a text that will enhance your clinical knowledge of the complex mechanisms, risks, and consequences of drug interactions associated with antimicrobials, infection, and inflammation. The third edition features five new chapters that cover material not addressed in previous editions. These new chapters describe interactions with a number of drug classes such as non-HIV antiviral, antimalarial, antiparasitic, antihelmintic, macrolide, azalide and ketolide agents. A novel chapter on probe cocktail studies has been included to highlight an important research tool for drug development. These chapters address material that cannot be retrieved easily in the medical literature. The highly acclaimed food-drug interactions as well as the study design and analysis chapters remain definitive references. The newly written drug-cytokine interaction highlights the need for our improved understanding of the complex interrelationship of acute infection, inflammation, and the risk of drug interactions. Informative tables on specific drug-drug interactions are provided throughout the chapters as a quick clinical resource. The Third Edition of Drug Interactions in Infectious Diseases is a distillation of relevant drug interactions associated with antimicrobials, infection, and inflammation. This concise review of the mechanisms and strategies to manage drug interactions should be valuable to all health care practitioners. Features * Definitive reference source of up-to-date information on antimicrobial drug interactions * Informative tables on the degree of interaction for specific antimicrobial agents * In-depth discussion of mechanisms and potential mechanistic pathways of interaction * New chapters on non-HIV antiviral, antimalarial, antiparasitic, and macrolide, azalide and ketolide agents * New chapter on probe-cocktail studies as a research tool to study drug-drug interactions * Inclusion of new antimicrobial agents and their associated drug interactions * First rate chapters on study design and analysis, and drug-food interactions * A fresh perspective on drug-cytokine interactions * Authoritative chapter on regulatory considerations of drug interactions during drug development

This volume contains the proceedings of the Ninth International Symposium on Cyclodextrins, held in Santiago de Compostela, Spain, May 31 - June 3, 1998. The papers collected represent a summary of the last two years' achievements in the application of cyclodextrins in such diverse fields as pharmaceuticals, biotechnology, textiles, chromatography and environmental sciences. Highlights: Chiral selection of chemicals, nuclear waste management, cyclodextrins in nasal drug delivery, cyclodextrins in pulmonary drug delivery, cyclodextrins as pharmaceutical excipients, pharmacokinetics, stabilization of drugs by cyclodextrins, structural characterization of cyclodextrin complexes by nuclear magnetic resonance and molecular modeling, artificial receptors, large cyclodextrins, cyclodextrins as enzyme models, new cyclodextrin derivatives and potentials. Audience: This book will be of interest to researchers whose work involves biotechnology, pharmaceuticals, food and chemicals and chromatographic methods, as well as fundamental cyclodextrin research.