Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences PDF Download

Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 9780849301377
Category : Science
Languages : en
Pages : 98

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Book Description
The Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences explains how to maintain a scientific log that will withstand peer, federal, and other reviewing agencies' scrutiny. This is a timely publication as the maintenance of a log becomes an increasingly more important issue. It covers data monitoring, recording and maintenance; quality assurance; and printed forms, and the laws and regulations that impact their design and use.

Author: Diane Schmidt
Publisher: CRC Press
ISBN: 0824741714
Category : Language Arts & Disciplines
Languages : en
Pages : 484

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Book Description
"Provides an in-depth review of current print and electronic tools for research in numerous disciplines of biology, including dictionaries and encyclopedias, method guides, handbooks, on-line directories, and periodicals. Directs readers to an associated Web page that maintains the URLs and annotations of all major Inernet resources discussed in th

Author: P.J. Bert Hakkinen
Publisher: Elsevier
ISBN: 008053466X
Category : Medical
Languages : en
Pages : 921

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Book Description
Information Resources in Toxicology, Third Edition is a sourcebook for anyone who needs to know where to find toxicology information. It provides an up-to-date selective guide to a large variety of sources--books, journals, organizations, audiovisuals, internet and electronic sources, and more. For the Third Edition, the editors have selected, organized, and updated the most relevant information available. New information on grants and other funding opportunities, physical hazards, patent literature, and technical reports have also been added. This comprehensive, time-saving tool is ideal for toxicologists, pharmacologists, drug companies, testing labs, libraries, poison control centers, physicians, legal and regulatory professionals, and chemists. Serves as an all-in-one resource for toxicology information New edition includes information on publishers, grants and other funding opportunities, physical hazards, patent literature, and technical reports Updated to include the latest internet and electronic sources, e-mail addresses, etc. Provides valuable data about the new fields that have emerged within toxicological research; namely, the biochemical, cellular, molecular, and genetic aspects

Author: Wanda M. Haschek
Publisher: Academic Press
ISBN: 0124157653
Category : Medical
Languages : en
Pages : 3054

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Book Description
Haschek and Rousseaux's Handbook of Toxicologic Pathology is a key reference on the integration of structure and functional changes in tissues associated with the response to pharmaceuticals, chemicals and biologics. The 3e has been expanded by a full volume, and covers aspects of safety assessment not discussed in the 2e. Completely revised with many new chapters, it remains the most authoritative reference on toxicologic pathology for scientists and researchers studying and making decisions on drugs, biologics, medical devices and other chemicals, including agrochemicals and environmental contaminants. New topics include safety assessment, the drug life cycle, risk assessment, communication and management, carcinogenicity assessment, pharmacology and pharmacokinetics, biomarkers in toxicologic pathology, quality assurance, peer review, agrochemicals, nanotechnology, food and toxicologic pathology, the environment and toxicologic pathology and more. Provides new chapters and in-depth discussion of timely topics in the area of toxicologic pathology and broadens the scope of the audience to include toxicologists and pathologists working in a variety of settings Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology Features hundreds of full color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

Author: Arthur D. Chapman
Publisher: GBIF
ISBN: 8792020038
Category : Biodiversity
Languages : en
Pages : 61

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Book Description

Author: Cédric Grueau
Publisher: Springer Nature
ISBN: 3030763749
Category : Computers
Languages : en
Pages : 177

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Book Description
This book constitutes selected, revised and extended papers of the 6th International Conference on Geographical Information Systems Theory, Applications and Management, GISTAM 2020, held in Prague, Czech Republic, May 2020. Due to the COVID-19 pandemic the conference was held online. The 9 revised full papers presented were carefully reviewed and selected from 62 submissions. The papers are centered on urban and regional planning; water information systems; geospatial information and technologies; spatio-temporal database management; decision support systems; energy information systems; GPS and location detection.

Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 9781420000559
Category : Medical
Languages : en
Pages : 708

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Book Description
"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."

Author: Shayne C. Gad
Publisher: Springer Nature
ISBN: 3030430731
Category : Medical
Languages : en
Pages : 515

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Book Description
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 directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.

Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119097401
Category : Medical
Languages : en
Pages : 918

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Book Description
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Author: Shayne C. Gad
Publisher: Springer Science & Business Media
ISBN: 9781461400493
Category : Medical
Languages : en
Pages : 212

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Book Description
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.