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Carcinogenicity
Offers comprehensive coverage of currently available cancer predictors, the most recent research on carcinogenicity, and the design and interpretation of carcinogenicity experiments. Presents mouse, rat, and human carcinogenicity data for the liver, kidney, breast, cervix, prostate, hematopoietic system, colon, skin, urinary bladder, mouth, stomach, thyroid, and pancreas.
Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.
Pharmaceutical Medicine
The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Carcinogenicity
Offers comprehensive coverage of currently available cancer predictors, the most recent research on carcinogenicity, and the design and interpretation of carcinogenicity experiments. Presents mouse, rat, and human carcinogenicity data for the liver, kidney, breast, cervix, prostate, hematopoietic system, colon, skin, urinary bladder, mouth, stomach, thyroid, and pancreas.
The Use of Short- and Medium-term Tests for Carcinogens and Data on Genetic Effects in Carcinogenic Hazard Evaluation
Lifetime assays for carcinogenicity in experimental animals, together with data on genetic and related effects on a variety of organisms, have long been the foundation for predictions of carcinogenic hazard to human beings. Recent scientific advances have provided new assays and novel test systems that are beginning to supplement, and in the future may even replace, the well-established tests that have been widely used for the last four decades. This publication reviews the evidence that justifies the use of lesions that precede histologically defined malignancy as endpoints to predict carcinogenicity. It evaluates the utility of non-mammalian species and of genetically engineered rodents as subjects for carcinogenicity tests and mutations in cancer-related genes in human and experimental animal tumours as 'footprints' of environmental carcinogens. It evaluates the use of established and novel assays for genetic toxicity in the prediction of carcinogenicity. Finally it formulates recommendations on the use of such data in the process of evaluation of carcinogenic hazards by the IARC Monographs on the Evaluation of Carcinogenic Risks to Humans.
OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies
These Guidance Notes outline core concepts in order to obviate the need to consult large numbers of text books, while still pointing the reader to sources of more detailed or specific information.
Issues in Risk Assessment
The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume. The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures. The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis.
