Download or read book Proceedings of the Second International Conference on Harmonisation written by Patrick Francis D'Arcy and published by . This book was released on 1994 with total page 772 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Transnational Economic Governance Regimes written by Christian Tietje and published by BRILL. This book was released on 2009-10-14 with total page 1105 pages. Available in PDF, EPUB and Kindle. Book excerpt: Non-governmental organizations, transnational business associations, private standard-setting bodies, public-private partnerships, and institutionalized incentive schemes now occupy a central place in the regulation and governance of transnational economic affairs alongside states and intergovernmental organizations. Much of the literature on these new and emerging patterns of governance has focused on the legal, political, and normative implications of this rapidly evolving landscape. The Handbook of Transnational Economic Governance Regimes expands on this scholarship by identifying, describing, and analysing more than 85 of the most significant actors in transnational governance. The Handbook examines the origins, evolution, structure, membership, financing, and strategies of key organizations and regulatory networks in almost every sphere of global economic activity, and analyses their role and influence in contemporary transnational economic governance.
Download or read book Proceedings of the Third International Conference on Harmonisation written by Patrick Francis D'Arcy and published by . This book was released on 1996 with total page 1090 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Academic Press. This book was released on 2001 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.
Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-03-05 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Download or read book Focus on Pharmaceutical Research written by José Luis Valverde and published by IOS Press. This book was released on 1999 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: The European Commission's Fifth Framework Programme for Research and Technological Development (1998-2002) has been recently launched. As often the case with new programmes, the time allows for a careful evaluation of the work concluded in the previous programme. This volume, the first in a series on Pharmaceuticals, policy and law, takes stock of the experience gathered in the field of pharmaceutical research in the BIOMED 2 Programme of the EU Fourth Framework Programme(1994-1998) , and attempts an analysis of the needs, opportunities and perspectives in the field from the various points of view of the academia, pharmaceutical industry, regulatory authorities, consumers and patients, including those suffering from rare diseases. The case for a robust system for pharmacovigilance in modern pharmacotherapy and underpinning research is defended.
Download or read book The Handbook of Transnational Governance written by Thomas Hale and published by John Wiley & Sons. This book was released on 2018-02-12 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: When we speak of global governance today, we no longer mean simply state-to-state diplomacy, international treaties, or intergovernmental organizations like the United Nations. Alongside these ‘traditional' elements of global politics are a host of new institutions ranging from global networks of governmental officials, to private codes of conduct for corporations, to action-oriented partnerships of NGOs, governments, corporations, and other actors. These innovative mechanisms offer intriguing solutions to pressing transnational challenges as diverse as climate change, financial governance, workers' rights, and public health. But they also raise new questions about the effectiveness and legitimacy of transnational governance. An expanding body of scholarship has sought to identify and assess these new forms of governance, but this young body of work has lacked a sense of the larger picture. This volume seeks to fill that need by presenting a comprehensive overview of new forms of transnational governance. This resource is essential for those who want to explain why transborder governance has changed and to understand what implications these changes have for global politics.
Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Download or read book Toxicology and Risk Assessment written by Helmut Greim and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new book, written by two outstanding scientists in the field, describes the basic principles of toxic mechanisms and organ toxicity, providing detailed information on specific mechanisms or chemicals for exemplification. The goal is to provide sufficient information that the reader becomes familiar with the basic concepts in toxicology to enable him or her to understand the basic principles in toxicology and to evaluate the risks at given exposures. With this basic understanding the reader also will be able to critically evaluate the available information on a chemical and to identify data gaps. In addition to the introductory chapters the book will offer the following systematic information, presented in six special sections: Principles in Toxicology Organ Toxicology Methods in Toxicology Risk Assessment Risk Management Toxicity of Chemicals Fulfilling a demand for such a book, this will be a welcomed introductory text for students and non-experts alike to focus on and understand the principles of hazard identification and risk assessment of toxicants. Relevant to all those studying toxicology, biochemistry, biology, medicine and chemistry, as well as toxicologists in hospitals, universities and in industry.
Download or read book Regulating Medicines in Europe written by John Abraham and published by Routledge. This book was released on 2014-04-04 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.
Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.
Download or read book Photostability Of Drugs And Drug Formulations written by Hanne Hjorth Tonnesen and published by CRC Press. This book was released on 1996-09-03 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text discusses various aspects of the combination of drugs and light. Degradation processes, stabilization of photolabile drug substances within formulations, benefits from the combination of drugs and light, and testing of drug photoreactivity, are some of the topics discussed.
Download or read book Environmental Health Perspectives written by and published by . This book was released on 1993 with total page 824 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
Download or read book Hayes Principles and Methods of Toxicology written by A. Wallace Hayes and published by CRC Press. This book was released on 2023-07-03 with total page 2143 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.
Download or read book Hayes Principles and Methods of Toxicology Sixth Edition written by A. Wallace Hayes and published by CRC Press. This book was released on 2014-10-10 with total page 2186 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hayes’ Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chapters that address the advances and developments since the fifth edition, the book presents everything toxicologists and students need to know to understand hazards and mechanisms of toxicity, enabling them to better assess risk. The book begins with the four basic principles of toxicology—dose matters, people differ, everything transforms, and timing is crucial. The contributors discuss various agents of toxicity, including foodborne, solvents, crop protection chemicals, radiation, and plant and animal toxins. They examine various methods for defining and measuring toxicity in a host of areas, including genetics, carcinogenicity, toxicity in major body systems, and the environment. This new edition contains an expanded glossary reflecting significant changes in the field. New topics in this edition include: The importance of dose–response Systems toxicology Food safety The humane use and care of animals Neurotoxicology The comprehensive coverage and clear writing style make this volume an invaluable text for students and a one-stop reference for professionals.
Download or read book Genetic Toxicology and Cancer Risk Assessment written by Wai Nang Choy and published by CRC Press. This book was released on 2001-08-31 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents state-of-the-art regulatory cancer risk assessment models including a biologically based model for two-hit carcinogenesis and cell proliferation! This book comprehensively reviews the various roles of genetic toxicology in human cancer risk assessment conducted by United States and worldwide regulatory agencies-discussing hazard identification, dose-response relationships, exposure assessment, and current practices of risk characterization. Examines predictive values of mutagenicity tests, mechanisms of carcinogenesis, and conventional genotoxicity tests required by the International Conference on Harmonization and the Organization for Economic Cooperation and Development/Environmental Protection Agency guidelines! Comprised of contributions from prominent experts and risk assessors and including nearly 1200 references to facilitate further study, Genetic Toxicology and Cancer Risk Assessment reviews contemporary human cancer genetics as related to the mutagenic nature of carcinogenesis calculates acceptable exposure levels based on a carcinogenic threshold dose for nongenotoxic carcinogens reveals the rationale and methodology of quantitative estimation of human cancer risks using mathematical models discusses the threshold concept of carcinogenesis demonstrates how bacterial mutagenicity assays are the most reliable for predicting rodent carcinogens considers structural activity relationship (SAR) analysis of chemical carcinogenicity describes the emergence of the mouse lymphoma microwell and in vitro micronucleus assays illustrates the use of genetic biomarkers for dosimetry analysis and more! Linking human cancer genetics, mutagenicity assays, mechanisms of carcinogenesis, carcinogenic thresholds, molecular epidemiology, mathematical modeling, and quantitative cancer risk analysis, Genetic Toxicology and Cancer Risk Assessment is a must-have reference for toxicologists; oncologists; geneticists; biostatisticians; reproductive, developmental, cell, and molecular biologists; endocrinologists; biochemists; and upper-level undergraduate, graduate, and medical school students in these disciplines.
