Pharmacokinetics and Toxicokinetic Considerations - Vol II

Pharmacokinetics and Toxicokinetic Considerations - Vol II
Author: Rakesh Kumar Tekade
Publisher: Academic Press
Total Pages: 816
Release: 2022-02-05
Genre: Business & Economics
ISBN: 0323913164

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Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists. Allows readers to systematically integrate up-to-date research findings into their laboratory work Presents focused explorations of bioanalytical methods for bioavailability and bioequivalence assessment Provides clinical applications of concepts

Essentials of Pharmatoxicology in Drug Research, Volume 1

Essentials of Pharmatoxicology in Drug Research, Volume 1
Author: Rakesh Kumar Tekade
Publisher: Elsevier
Total Pages: 754
Release: 2023-03-23
Genre: Medical
ISBN: 044315841X

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Toxicity and Toxicodynamics, Volume One in the Essentials of Pharmatoxicology in Drug Research series provides an overview on the essentials of toxicology, risk assessment and the mechanisms. Topics discussed include the types of cellular responses to chemical toxicants, mechanisms of drug toxicity, and their relevance to pharmaceutical product development. The book examines omics and computer-aided technologies for mechanistic and predictive toxicology and covers state-of-art testing in the evaluation of detrimental pathways, dose selection in toxicity studies, as well as the role of regulatory agencies in toxicity studies. In addition, there is also discussion on clinical interventions such as pharmacotherapy and managed care strategies for acute poisoning. This volume is a valuable resource to those learning more about the drug development process related to toxicology and those who want to get an update on newer concepts on the toxicology aspect of drug research. Examines toxicological risk assessment in drug research Discusses toxicity mechanisms Covers risk assessment and the use of omics and computational technologies in mechanistic and predictive toxicology Offers clinical interventions and managed care as a result of toxic injury and acute poisoning

Toxicokinetics and Risk Assessment

Toxicokinetics and Risk Assessment
Author: John C. Lipscomb
Publisher: CRC Press
Total Pages: 388
Release: 2016-04-19
Genre: Medical
ISBN: 1000612139

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Toxicokinetics in Risk Assessment discusses the noncancer risk assessment process and its reliance on uncertainty factors in order to facilitate the continued study and refinement of the scientific basis for health risk assessment. This text clearly demonstrates the application of physiologically-based pharmacokinetic (PBPK) modeling in human healt

Strategies to Protect the Health of Deployed U.S. Forces

Strategies to Protect the Health of Deployed U.S. Forces
Author: National Research Council
Publisher: National Academies Press
Total Pages: 388
Release: 2000-03-17
Genre: Medical
ISBN: 0309172535

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Risk management is especially important for military forces deployed in hostile and/or chemically contaminated environments, and on-line or rapid turn-around capabilities for assessing exposures can create viable options for preventing or minimizing incapaciting exposures or latent disease or disability in the years after the deployment. With military support for the development, testing, and validation of state-of-the-art personal and area sensors, telecommunications, and data management resources, the DOD can enhance its capabilities for meeting its novel and challenging tasks and create technologies that will find widespread civilian uses. Strategies to Protect the Health of Deployed U.S. Forces assesses currently available options and technologies for productive pre-deployment environmental surveillance, exposure surveillance during deployments, and retrospective exposure surveillance post-deployment. This report also considers some opportunities for technological and operational advancements in technology for more effective exposure surveillance and effects management options for force deployments in future years.

Regulatory Toxicology

Regulatory Toxicology
Author: Franz-Xaver Reichl
Publisher: Springer
Total Pages: 0
Release: 2014-03-27
Genre: Medical
ISBN: 9783642353734

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This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.

Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde

Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde
Author: National Research Council
Publisher: National Academies Press
Total Pages: 204
Release: 2011-05-31
Genre: Science
ISBN: 0309211964

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Formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily. Formaldehyde is used to produce a wide array of products, particularly building materials; it is emitted from many sources, including power plants, cars, gas and wood stoves, and cigarettes; it is a natural product in come foods; and it is naturally present in the human body as a metabolic intermediate. Much research has been conducted on the health effects of exposure to formaldehyde, including effects on the upper airway, where formaldehyde is deposited when inhaled, and effects on tissues distant from the site of initial contact. The U.S. Environmental Protection Agency (EPA) released noncancer and cancer assessments of formaldehyde for its Intergated Risk Information System (IRIS) in 1990 and 1991, respectively. The agency began reassessing formaldehyde in 1998 and released a draft IRIS assessment in June 2010. Given the complexity of the issues and the knowledge that the assessment will be used as the basis of regulatory decisions, EPA asked the National Research Council (NRC) to conduct an independent scientific review of the draft IRIS assessment. In this report, the Committee to Review EPA's Draft IRIS Assessment of Formaldehyde first addresses some general issues associated with the draft IRIS assessment. The committee next focuses on questions concerning specific aspects of the draft assessment, including derivation of the reference concentrations and the cancer unit risk estimates for formaldehyde. The committee closes with recommendations for improving the IRIS assessment of formaldehyde and provides some general comments on the IRIS development process.

Public Health and Toxicology Issues in Drug Research, Volume 2

Public Health and Toxicology Issues in Drug Research, Volume 2
Author: Rakesh Kumar Tekade
Publisher: Elsevier
Total Pages: 854
Release: 2024-04-05
Genre: Medical
ISBN: 0443158436

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Toxicodynamics in Drug Research, Volume 2: Public Health and Toxicology Issues examines the implications of public health issues and the impact of pharmaceuticals, chemical and food toxicants, dietary phytochemicals, and medical treatments on human health. Volume 2: Public Health and Toxicology Issues in Drug Research: Toxicity and Toxicodynamics covers topics on pharmacokinetics and toxicokinetics such as population pharmacokinetics/toxicokinetics, the design of toxicokinetic studies, and the use of toxicokinetic data in preclinical safety assessments. The book investigates the health effect caused by the bioaccumulation of pharmaceutical and personal care products and the impact of drug-induced toxicity on different systems of the body. It discusses the mechanistic pathways of food toxicants and illustrates the molecular mechanisms of the chemopreventive role of dietary phytochemicals. It also delves into the toxic effects of medical treatments and materials. Ethical, legal, societal, and professional issues in toxicology round off the coverage providing a valuable resource to interested in learning more about the health impact and public health issues related to the toxicity of pharmaceuticals, dietary supplements, personal care products, and medical treatments. Discusses the impact of pharmaceuticals, food, and chemical toxicants on human health Examines the toxic effects of medical treatments, clinical administrations, and materials Explores public health issues around drug safety and toxicology

Biomarkers in Toxicology

Biomarkers in Toxicology
Author: Ramesh C Gupta
Publisher: Academic Press
Total Pages: 1149
Release: 2014-01-25
Genre: Technology & Engineering
ISBN: 0124046495

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Biomarkers in Toxicology is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This book includes both vertebrate and non-vertebrate species models for toxicological testing and development of biomarkers. Divided into several key sections, this reference volume contains chapters devoted to topics in molecular-cellular toxicology, as well as a look at the latest cutting-edge technologies used to detect biomarkers of exposure and effects. Each chapter also contains several references to the current literature and important resources for further reading. Given this comprehensive treatment, Biomarkers in Toxicology is an essential reference for all those interested in biomarkers across several scientific and biomedical fields. Written by international experts who have evaluated the expansive literature to provide you with one resource covering all aspects of toxicology biomarkers Identifies and discusses the most sensitive, accurate, unique and validated biomarkers used as indicators of exposure and effect of chemicals of different classes Covers special topics and applications of biomarkers, including chapters on molecular toxicology biomarkers, biomarker analysis for nanotoxicology, development of biomarkers for drug efficacy evaluation and much more

Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes
Author: National Research Council
Publisher: National Academies Press
Total Pages: 226
Release: 2004-06-04
Genre: Science
ISBN: 0309166411

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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.

Handbook of LC-MS Bioanalysis

Handbook of LC-MS Bioanalysis
Author: Wenkui Li
Publisher: John Wiley & Sons
Total Pages: 709
Release: 2013-09-03
Genre: Science
ISBN: 111867135X

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Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.