Drug Metabolism In The Immature Human

The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Covering some of the most important topics in modern toxicology, the Handbook of Human Toxicology is a unique and valuable addition to the current literature. It addresses issues, answers questions, and provides data related to. Within each of these five major sections are several carefully selected topics that reflect the current state of human to

This important, new reference provides the first , up-to-date, and comprehensive treatmentof the various liquid chromatography (LC) instrumentation for Therapeutic DrugMonitoring (TDM) and toxicology drug assays and reviews the clinical pharmacologyof major classes of drugs and their LC analyses.Written by authoritative contributors who bring many years of personal laboratory/clinical experience to the book, this interdisciplinary work : presents the principlesof TDM, sampling techniques, and various instrumentation topics, including computerinterfacing, mass spectrometry, fluorescence , electrochemical detection, and bloodcollection devices . .. examines six primary classes of drugs, complete with recommendedLC procedures and emphasizing recently introduced drugs and their LC analyses. .. and documents medicolegal guidelines and laboratory management considerations,providing a contemporary assessment of today's laboratory needs.The only practical, current guide available on the subject, Therapeutic Drug Monitoringand Toxicology by Li([uid Chromatography belongs in the personal libraries of clinicaland analytical chemists and biochemists, clinical pharmacologists, clinical toxicologists,clinical pathologists, immunologists, liquid chromatographers, mass spectroscopists, laboratorydirectors, laboratory instrument manufacturers , and medical technologists. Thebook is also vital supplementary reading for advanced undergraduate and graduate-levelclinical chemistry, toxicology, clinical pathology, and liquid chromatography course.

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade’s numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics All chapters are written by experts with a wide range of practical experience from the industry and academia

Handbook of Mammalian Metabolism of Plant Compounds provides an extensive survey of how mammals metabolize compounds found in higher plants. Information about these compounds is important to researchers in pharmacology, toxicology, medical and natural products chemistry, and food sciences. Although there is plenty of literature about mammalian metabolism of plant compounds, it is scattered, and summaries of specific plant compounds are often difficult to obtain. This book contains 11 chapters discussing the metabolic fate of individual plant compounds grouped according to chemical class. It also features structural formulas of the compounds and their metabolites, including probable pathways of metabolism. This book provides a convenient single-volume reference source that will benefit all researchers requiring this type of information.