Drug Metabolism in the Immature Human
Author: Lester F. Soyka
Publisher:
Published: 1981
Total Pages: 301
ISBN-13: 9780783771618
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Drug Metabolism in the Immature Human
Author: Lester F. Soyka
Publisher: Raven Press (ID)
Published: 1981
Total Pages: 312
ISBN-13:
DOWNLOAD EBOOK →Interindividual Variability in Human Drug Metabolism
Author: Gian Maria Pacifici
Publisher: CRC Press
Published: 2001-05-24
Total Pages: 560
ISBN-13: 9780748408641
DOWNLOAD EBOOK →The book provides an exhaustive, authoritative and updated review on the interindividual variability in drug metabolism in humans. Four chapters address the general background: genetic factors causing variability, interethnic variability, environmental factors and developing and ageing as sources of variability. Six chapters address variability of drug metabolism in vivo: variability of psychotropic drugs, antiepileptic drugs, the dopamine precursor levodopa, cardiovascular active drugs and anti HIV drugs. Seven chapters address the interindividual variability of the main drug metabolizing enzymes: CYP-450s, acetyltransferases, glucuronosyl transferase, methyl transferases, sulfotransferases and glutathione transferases in human liver and extrahepatic tissues. A separate chapter discusses the prediction of drug interaction. Comprehensive in coverage, and with contributions from the leading international experts, this book is essential reading for researchers from both academia and the pharmaceutical industry. Advanced undergraduates and postgraduates in pharmacology, clinical pharmacology, toxicology, biochemistry and epidemiology who are interested in drug metabolism will also find this an indispensable resource.
Intentional Human Dosing Studies for EPA Regulatory Purposes
Author: National Research Council
Publisher: National Academies Press
Published: 2004-06-04
Total Pages: 226
ISBN-13: 0309166411
DOWNLOAD EBOOK →The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.
Safe and Effective Medicines for Children
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2012-10-13
Total Pages: 432
ISBN-13: 0309225493
DOWNLOAD EBOOK →The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Handbook of Human Toxicology
Author: Edward J. Massaro
Publisher: CRC Press
Published: 1997-07-09
Total Pages: 1196
ISBN-13: 9781439805756
DOWNLOAD EBOOK →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
Oxford Textbook of Obstetric Anaesthesia
Author: Vicki Clark
Publisher: Oxford University Press
Published: 2016
Total Pages: 1017
ISBN-13: 0198713339
DOWNLOAD EBOOK →This textbook provides an up-to-date summary of the scientific basis, assessment for and provision of anaesthesia throughout pregnancy and labour. It is divided into nine sections including physiology, assessment, complications and systemic disease.
Therapeutic Drug Monitoring and Toxicology by Liquid Chromatography
Author: Steven H.Y. Wong
Publisher: Routledge
Published: 2017-09-19
Total Pages: 521
ISBN-13: 135140847X
DOWNLOAD EBOOK →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.
Pesticides in the Diets of Infants and Children
Author: National Research Council
Publisher: National Academies Press
Published: 1993-02-01
Total Pages: 402
ISBN-13: 0309048753
DOWNLOAD EBOOK →Many of the pesticides applied to food crops in this country are present in foods and may pose risks to human health. Current regulations are intended to protect the health of the general population by controlling pesticide use. This book explores whether the present regulatory approaches adequately protect infants and children, who may differ from adults in susceptibility and in dietary exposures to pesticide residues. The committee focuses on four major areas: Susceptibility: Are children more susceptible or less susceptible than adults to the effects of dietary exposure to pesticides? Exposure: What foods do infants and children eat, and which pesticides and how much of them are present in those foods? Is the current information on consumption and residues adequate to estimate exposure? Toxicity: Are toxicity tests in laboratory animals adequate to predict toxicity in human infants and children? Do the extent and type of toxicity of some chemicals vary by species and by age? Assessing risk: How is dietary exposure to pesticide residues associated with response? How can laboratory data on lifetime exposures of animals be used to derive meaningful estimates of risk to children? Does risk accumulate more rapidly during the early years of life? This book will be of interest to policymakers, administrators of research in the public and private sectors, toxicologists, pediatricians and other health professionals, and the pesticide industry.
Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters
Author: Shuguang Ma
Publisher: Elsevier
Published: 2020-07-09
Total Pages: 710
ISBN-13: 0128200197
DOWNLOAD EBOOK →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
