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Contract Research and Development Organizations-Their History, Selection, and Utilization
This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete ...
The Role of the Study Director in Nonclinical Studies
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Hayes' Principles and Methods of Toxicology
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 chap
A Comprehensive Guide to Toxicology in Preclinical Drug Development
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation,...
Statement of Disbursements of the House
Covers receipts and expenditures of appropriations and other funds.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development
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 n...
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