Search Results: the-role-of-the-study-director-in-nonclinical-studies-pharmaceuticals-chemicals-medical-devices-and-pesticides

The Role of the Study Director in Nonclinical Studies

Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

Author: William J. Brock

Publisher: John Wiley & Sons

ISBN: 1118874080

Category: Science

Page: 560

View: 1528

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

Pathology for Toxicologists

Principles and Practices of Laboratory Animal Pathology for Study Personnel

Author: Elizabeth McInnes

Publisher: John Wiley & Sons

ISBN: 1118755405

Category: Science

Page: 216

View: 7308

Non-pathologists, such as toxicologists and study personnel, can find it difficult to understand the data they receive from pathologists. Toxicological pathologists write long, detailed and highly technical reports. Study personnel are under daily pressure to decide whether lesions described in pathology reports are treatment-related and thus important to the pharmaceutical company or whether the lesions are background changes and thus of little significance. Written by experienced toxicological pathologists, Pathology for Toxicologists: Principles and Practices of Laboratory Animal Pathology for Study Personnel serves to bridge the gap in the understanding of pathology data, enabling non-pathologists to more easily comprehend pathology reports, better integrate pathology data into final study reports and ask pathologists relevant questions about the test compound. This succinct, fully referenced, full colour book is suitable for toxicologists at all stages of their training or career who want to know more about the pathology encountered in laboratory animals used in safety studies. Key features include important chapters on spontaneous and target organ lesions in rats, mice, non-human primates, mini pigs, rabbits and beagle dogs as well as information on general pathology, macroscopic target organ lesions, ancillary pathology techniques, haematology, biochemistry and adversity. Pathology for Toxicologists: Principles and Practices of Laboratory Animal Pathology for Study Personnel includes: Colour diagrams explaining how lesions are caused by either external compounds or spontaneously The anatomic variations and background lesions of laboratory animals Advice on sampling tissues, necropsy, ancillary pathology techniques and recording data A chapter on the haematology and biochemistry of laboratory animals Full colour photographs of common macroscopic lesions encountered in laboratory animals A comprehensive glossary

Statistical Analysis of Ecotoxicity Studies

Author: John W. Green,Timothy A. Springer,Henrik Holbech

Publisher: John Wiley & Sons

ISBN: 1119488826

Category: Science

Page: 416

View: 4995

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.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author: Ali S. Faqi

Publisher: Academic Press

ISBN: 0123878152

Category: Medical

Page: 885

View: 6812

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, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

The Minipig in Biomedical Research

Author: Peter A. McAnulty,Anthony D. Dayan,Niels-Christian Ganderup,Kenneth L. Hastings

Publisher: CRC Press

ISBN: 1439811180

Category: Medical

Page: 662

View: 9482

The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors’ global contacts and experience with regulatory authorities and the pharmaceutical and other industries, this accessible manual ranges widely over the biological, scientific, and practical uses of the minipig in the laboratory. Its coverage extends from the minipig’s origins, anatomy, genetics, immunology, and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. Regulatory aspects of its use are considered. The reader will find an extensive amount of theoretical and practical information in the pharmacology; ADME and toxicology chapters which will help scientists and managers when deciding which species to use in basic research; drug discovery and pharmacology; and toxicology studies of chemicals, biotechnology products and devices. The book discusses regulatory uses of minipigs in the evaluation of human and veterinary pharmaceuticals, medical devices, and other classes of xenobiotics. It describes features of normal health, normal laboratory values, and common diseases. It also carefully elucidates ethical and legal considerations in their supply, housing, and transport. The result is an all-inclusive and up to date manual about the experimental uses of the minipig that describes ‘How to’ and ‘Why’ and ’What to expect in the normal’, combining enthusiasm and experience with critical assessment of its values and potential problems.

Veterinary and Human Toxicology

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Veterinary toxicology

Page: N.A

View: 3339

New Scientist

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Science

Page: N.A

View: 7010

Who's who in European Research and Development

Author: European research and development database

Publisher: N.A

ISBN: 9783598115769

Category: Science

Page: 1097

View: 6552

Genetic Engineering and Biotechnology Firms Worldwide Directory

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Biomedical engineering

Page: N.A

View: 1039

Genetic Engineering News

GEN.

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Genetic engineering

Page: N.A

View: 3922

Science

v.1-v.219

Author: N.A

Publisher: N.A

ISBN: N.A

Category:

Page: N.A

View: 2919

Genetic Engineering News Guide to Biotechnology Companies

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Biotechnology industries

Page: N.A

View: 3039

Progress in Toxicology

Special Topics

Author: Gerhard Zbinden

Publisher: Springer-Verlag

ISBN: 3642662927

Category: Science

Page: 120

View: 1036

Consultants and Consulting Organizations Directory

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Business consultants

Page: N.A

View: 7111

Indexes are arranged by geographic area, activities, personal name, and consulting firm name.

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

Author: H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer

Publisher: Springer

ISBN: 9783642252396

Category: Medical

Page: 1404

View: 7875

-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide

Methodenlehre der Therapeutischen Untersuchung

Author: Paul Martini

Publisher: Springer-Verlag

ISBN: 3662410915

Category: Medical

Page: 72

View: 5733

Dieser Buchtitel ist Teil des Digitalisierungsprojekts Springer Book Archives mit Publikationen, die seit den Anfängen des Verlags von 1842 erschienen sind. Der Verlag stellt mit diesem Archiv Quellen für die historische wie auch die disziplingeschichtliche Forschung zur Verfügung, die jeweils im historischen Kontext betrachtet werden müssen. Dieser Titel erschien in der Zeit vor 1945 und wird daher in seiner zeittypischen politisch-ideologischen Ausrichtung vom Verlag nicht beworben.

Die Nebenwirkungen der Arzneimittel

Author: Louis Lewin

Publisher: Рипол Классик

ISBN: 5880192415

Category: History

Page: N.A

View: 5055

Clariant clareant

Die Anfänge eines Spezialitätenchemiekonzerns

Author: Anna Bálint

Publisher: Campus Verlag

ISBN: 3593393751

Category: Political Science

Page: 308

View: 1531

Die Wurzeln des weltweit tätigen Chemiekonzerns Clariant liegen in den beiden Traditionsunternehmen Sandoz und Hoechst. Die anfänglichen Schritte, die Geschichte der Verschmelzung zweier unterschiedlicher Firmenkulturen sowie die Herausforderungen von Expansion und Aufstieg zu einem der führenden Anbieter von Spezialchemikalien wird hier fern jeder Schönfärberei erstmals erzählt. Zahlreiche Zeitzeugenberichte und Interviews geben authentische Einblicke in die wechselvollen Anfangsjahre von Clariant.

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