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Author: Lester F. Soyka
Publisher:
Published: 1981
Total Pages: 301
ISBN-13: 9780783771618
DOWNLOAD EBOOKDownload or read book Drug Metabolism in the Immature Human written by Lester F. Soyka and published by . This book was released on 1981 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: Lester F. Soyka
Publisher: Raven Press (ID)
Published: 1981
Total Pages: 312
ISBN-13:
DOWNLOAD EBOOKDownload or read book Drug Metabolism in the Immature Human written by Lester F. Soyka and published by Raven Press (ID). This book was released on 1981 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author: National Research Council
Publisher: National Academies Press
Published: 2004-06-04
Total Pages: 226
ISBN-13: 0309166411
DOWNLOAD EBOOKThe 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.
Download or read book Intentional Human Dosing Studies for EPA Regulatory Purposes written by National Research Council and published by National Academies Press. This book was released on 2004-06-04 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2012-10-13
Total Pages: 432
ISBN-13: 0309225493
DOWNLOAD EBOOKThe 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.
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author: Penny North-Lewis
Publisher:
Published: 2008
Total Pages: 348
ISBN-13:
DOWNLOAD EBOOKThis practical guide covers background information on liver function, the principles of drug use in liver disease and includes a section of worked examples of commonly asked questions. It will be invaluable to clinical pharmacists and anyone making medicine choices in patients with liver impairment.
Download or read book Drugs and the Liver written by Penny North-Lewis and published by . This book was released on 2008 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide covers background information on liver function, the principles of drug use in liver disease and includes a section of worked examples of commonly asked questions. It will be invaluable to clinical pharmacists and anyone making medicine choices in patients with liver impairment.
Author: Vicki Clark
Publisher: Oxford University Press
Published: 2016
Total Pages: 1017
ISBN-13: 0198713339
DOWNLOAD EBOOKThis 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.
Download or read book Oxford Textbook of Obstetric Anaesthesia written by Vicki Clark and published by Oxford University Press. This book was released on 2016 with total page 1017 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author: Edward J. Massaro
Publisher: CRC Press
Published: 1997-07-09
Total Pages: 1196
ISBN-13: 9781439805756
DOWNLOAD EBOOKCovering 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
Download or read book Handbook of Human Toxicology written by Edward J. Massaro and published by CRC Press. This book was released on 1997-07-09 with total page 1196 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author: Sumner J. Yaffe
Publisher: Lippincott Williams & Wilkins
Published: 2011
Total Pages: 1072
ISBN-13: 0781795389
DOWNLOAD EBOOK"Neonatal and Pediatric Pharmacology offers guidelines for safe, effective, and rational drug therapy in newborns, children and adolescents. The book provides relevant and useful data on the molecular, physiologic, biochemical, and pharmacologic mechanisms of drug action and therapy in this population. The authors identify areas of innovative basic and translational research necessary for the continuing evaluation and development of drugs for the fetus, newborns, children and adolescents. Neonatal and Pediatric Pharmacology is is a valuable reference for all health care professionals who treat the fetus, newborns, children, and adolescents, including neonatologists, nurses, pediatricians, general practitioners, students, obstetricians, perinatologists, surgeons and allied health professionals. It will be useful anytime during the day and especially in the middle of the night when knowledge of appropriate indications, safe and effective use, dosage, and therapeutic regimen for a certain drug or molecular entity is immediately needed. The book is also directed to those involved in basic, clinical, and other academic pharmacological research, the pharmaceutical industry, and regulatory agencies dealing with drug and therapeutic developments for this population. Those teaching pharmacology and therapeutics will find this compilation of information extremely useful in preparing teaching materials"--Provided by publisher.
Download or read book Neonatal and Pediatric Pharmacology written by Sumner J. Yaffe and published by Lippincott Williams & Wilkins. This book was released on 2011 with total page 1072 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Neonatal and Pediatric Pharmacology offers guidelines for safe, effective, and rational drug therapy in newborns, children and adolescents. The book provides relevant and useful data on the molecular, physiologic, biochemical, and pharmacologic mechanisms of drug action and therapy in this population. The authors identify areas of innovative basic and translational research necessary for the continuing evaluation and development of drugs for the fetus, newborns, children and adolescents. Neonatal and Pediatric Pharmacology is is a valuable reference for all health care professionals who treat the fetus, newborns, children, and adolescents, including neonatologists, nurses, pediatricians, general practitioners, students, obstetricians, perinatologists, surgeons and allied health professionals. It will be useful anytime during the day and especially in the middle of the night when knowledge of appropriate indications, safe and effective use, dosage, and therapeutic regimen for a certain drug or molecular entity is immediately needed. The book is also directed to those involved in basic, clinical, and other academic pharmacological research, the pharmaceutical industry, and regulatory agencies dealing with drug and therapeutic developments for this population. Those teaching pharmacology and therapeutics will find this compilation of information extremely useful in preparing teaching materials"--Provided by publisher.
Author: Shuguang Ma
Publisher: Elsevier
Published: 2020-07-09
Total Pages: 710
ISBN-13: 0128200197
DOWNLOAD EBOOKIdentification 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
Download or read book Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters written by Shuguang Ma and published by Elsevier. This book was released on 2020-07-09 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author: National Institute on Drug Abuse
Publisher:
Published: 1985
Total Pages: 162
ISBN-13:
DOWNLOAD EBOOKThis monograph is based upon papers presented at a technical review on prenatal drug exposure and consequences of maternal drug use which took place on September 24-25, 1984, at Bethesda, Maryland. The meeting was sponsored by the Division of Clinical Research and Division of Preclinical Research, National Institute on Drug Abuse. The clinical papers have been published separately as NIDA Research Monograph 59, "Current research on the consequences of maternal drug abuse."
Download or read book Prenatal Drug Exposure written by National Institute on Drug Abuse and published by . This book was released on 1985 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph is based upon papers presented at a technical review on prenatal drug exposure and consequences of maternal drug use which took place on September 24-25, 1984, at Bethesda, Maryland. The meeting was sponsored by the Division of Clinical Research and Division of Preclinical Research, National Institute on Drug Abuse. The clinical papers have been published separately as NIDA Research Monograph 59, "Current research on the consequences of maternal drug abuse."
