Statistical Analysis of Ecotoxicity Studies


Book Description

A guide to the issues relevant to the design, analysis, and interpretation of toxicity studies that examine chemicals for use in the environment Statistical Analysis of Ecotoxicity Studies offers a guide to the design, analysis, and interpretation of a range of experiments that are used to assess the toxicity of chemicals. While the book highlights ecotoxicity studies, the methods presented are applicable to the broad range of toxicity studies. The text contains myriad datasets (from laboratory and field research) that clearly illustrate the book's topics. The datasets reveal the techniques, pitfalls, and precautions derived from these studies. The text includes information on recently developed methods for the analysis of severity scores and other ordered responses, as well as extensive power studies of competing tests and computer simulation studies of regression models that offer an understanding of the sensitivity (or lack thereof) of various methods and the quality of parameter estimates from regression models. The authors also discuss the regulatory process indicating how test guidelines are developed and review the statistical methodology in current or pending OECD and USEPA ecotoxicity guidelines. This important guide: Offers the information needed for the design and analysis to a wide array of ecotoxicity experiments and to the development of international test guidelines used to assess the toxicity of chemicals Contains a thorough examination of the statistical issues that arise in toxicity studies, especially ecotoxicity Includes an introduction to toxicity experiments and statistical analysis basics Includes programs in R and excel Covers the analysis of continuous and Quantal data, analysis of data as well as Regulatory Issues Presents additional topics (Mesocosm and Microplate experiments, mixtures of chemicals, benchmark dose models, and limit tests) as well as software Written for directors, scientists, regulators, and technicians, Statistical Analysis of Ecotoxicity Studies provides a sound understanding of the technical and practical issues in designing, analyzing, and interpreting toxicity studies to support or challenge chemicals for use in the environment.




The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment


Book Description

The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. - Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more - Includes practical examples on techniques and methods to guide your daily practice - Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes




Statistical Issues in Drug Research and Development


Book Description

This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.




Statistical Analysis of Ecotoxicity Studies


Book Description

A guide to the issues relevant to the design, analysis, and interpretation of toxicity studies that examine chemicals for use in the environment Statistical Analysis of Ecotoxicity Studies offers a guide to the design, analysis, and interpretation of a range of experiments that are used to assess the toxicity of chemicals. While the book highlights ecotoxicity studies, the methods presented are applicable to the broad range of toxicity studies. The text contains myriad datasets (from laboratory and field research) that clearly illustrate the book's topics. The datasets reveal the techniques, pitfalls, and precautions derived from these studies. The text includes information on recently developed methods for the analysis of severity scores and other ordered responses, as well as extensive power studies of competing tests and computer simulation studies of regression models that offer an understanding of the sensitivity (or lack thereof) of various methods and the quality of parameter estimates from regression models. The authors also discuss the regulatory process indicating how test guidelines are developed and review the statistical methodology in current or pending OECD and USEPA ecotoxicity guidelines. This important guide: Offers the information needed for the design and analysis to a wide array of ecotoxicity experiments and to the development of international test guidelines used to assess the toxicity of chemicals Contains a thorough examination of the statistical issues that arise in toxicity studies, especially ecotoxicity Includes an introduction to toxicity experiments and statistical analysis basics Includes programs in R and excel Covers the analysis of continuous and Quantal data, analysis of data as well as Regulatory Issues Presents additional topics (Mesocosm and Microplate experiments, mixtures of chemicals, benchmark dose models, and limit tests) as well as software Written for directors, scientists, regulators, and technicians, Statistical Analysis of Ecotoxicity Studies provides a sound understanding of the technical and practical issues in designing, analyzing, and interpreting toxicity studies to support or challenge chemicals for use in the environment.




Handbook of Developmental Neurotoxicology


Book Description

Handbook of Developmental Neurotoxicology, Second Edition, provides a comprehensive view of the fundamental aspects of neurodevelopment, the pathways and agents that affect them, relevant clinical syndromes, and risk assessment procedures for developmental neurotoxicants. The editors and chapter authors are internationally recognized experts whose collaboration heralds a remarkable advance in the field, bridging developmental neuroscience with the principles of neurotoxicology. The book features eight new chapters with newly recruited authors, making it an essential text for students and professionals in toxicology, neurotoxicology, developmental biology, pharmacology, and neuroscience. - Presents a comprehensive, up-to-date resource on developmental neurotoxicology with updated chapters from the first edition - Contains new chapters that focus on subjects recent to the field - Includes well-illustrated material, with diagrams, charts, and tables - Contains compelling case studies and chapters written by world experts




Small Clinical Trials


Book Description

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.




Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity


Book Description

The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research).




Neurobehavioral Toxicity


Book Description

In establishing how certain chemicals can cause behavioural disorders, the process of neurotoxicity risk assessment poses significant challenges to every discipline within neuroscience. In this volume, leaders from industrial, academic, and government settings share insights on behavioural measurement in neurotoxicity risk assessment, and address the critical scientific issues arising from the expanding role of neurobehavioral toxicology in public policy development.; The authors set out to provide a comprehensive and authoritative review of current methods in the analysis and interpretation of neurobehavioural toxicology. Coverage begins with a discussion of criteria for determining neurotoxic potential. The next section examines neurobehavioural evaluations in developmental neurotoxicity. Subsequent sections focus on activity and observational data and applications of schedule-controlled operant behaviour in toxicity testing. The contributors address controversies surrounding the suitability and interpretation of procedures designed for neurotoxicological assessments. Some case studies are also included.




Statistics for Environmental Biology and Toxicology


Book Description

Statistics for Environmental Biology and Toxicology presents and illustrates statistical methods appropriate for the analysis of environmental data obtained in biological or toxicological experiments. Beginning with basic probability and statistical inferences, this text progresses through non-linear and generalized linear models, trend testing, time-to-event data and analysis of cross-classified tabular and categorical data. For the more complex analyses, extensive examples including SAS and S-PLUS programming code are provided to assist the reader when implementing the methods in practice.




A Comprehensive Guide to Toxicology in Nonclinical Drug Development


Book Description

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more - Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology