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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
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
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.
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.
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.
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
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. - Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences - Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics - Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology
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
This is a revised and very expanded version of the previous second edition of the book. "Pharmacokinetic and Pharmacodynamic Data Analysis" provides an introduction into pharmacokinetic and pharmacodynamic concepts using simple illustrations and reasoning. It describes ways in which pharmacodynamic and pharmacodynamic theory may be used to give insight into modeling questions and how these questions can in turn lead to new knowledge. This book differentiates itself from other texts in this area in that it bridges the gap between relevant theory and the actual application of the theory to real life situations. The book is divided into two parts; the first introduces fundamental principles of PK and PD concepts, and principles of mathematical modeling, while the second provides case studies obtained from drug industry and academia. Topics included in the first part include a discussion of the statistical principles of model fitting, including how to assess the adequacy of the fit of a model, as well as strategies for selection of time points to be included in the design of a study. The first part also introduces basic pharmacokinetic and pharmacodynamic concepts, including an excellent discussion of effect compartment (link) models as well as indirect response models. The second part of the text includes over 70 modeling case studies. These include a discussion of the selection of the model, derivation of initial parameter estimates and interpretation of the corresponding output. Finally, the authors discuss a number of pharmacodynamic modeling situations including receptor binding models, synergy, and tolerance models (feedback and precursor models). This book will be of interest to researchers, to graduate students and advanced undergraduate students in the PK/PD area who wish to learn how to analyze biological data and build models and to become familiar with new areas of application. In addition, the text will be of interest to toxicologists interested in learning about determinants of exposure and performing toxicokinetic modeling. The inclusion of the numerous exercises and models makes it an excellent primary or adjutant text for traditional PK courses taught in pharmacy and medical schools. A diskette is included with the text that includes all of the exercises and solutions using WinNonlin.