Shayne C. Gad's Books

Statistics and Experimental Design for Toxicologists and Pharmacologists, Fourth Edition

By: Shayne C. Gad

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Statistics and Experimental Design for Toxicologists and Pharmacologists, Fourth Edition

By: Shayne C. Gad

Purposefully designed as a resource for practicing and student toxicologists, Statistics and Experimental Design for Toxicologists and Pharmacologists, Fourth Edition equips you for the regular statistical analysis of experimental data. Starting with the assumption of basic mathematical skills and knowledge, the author supplies a complete and systematic yet practical introduction to the statistical methodologists available for, and used in, the discipline. For every technique presented, a worked example from toxicology is also presented. See what's new in the Fourth Edition: The first practical guide to performing meta analysis allowing for using the power inherent in multiple similar studies Coverage of Bayesian analysis and data analysis in pharmacology and toxicology Almost 200 problems with solutions Discussion of analysis of receptor binding assays, safety pharmacology assays and other standard types conducted in pharmacology A new chapter explaining the basics of Good Laboratory Practices (GLPs) For those with computer skills, this edition has been enhanced with the addition of basic SAS Written specifically for toxicologists and pharmacologists, the author draws on more than 30 years of experience to provide understanding of the philosophical underpinnings for the overall structure of analysis. The book's organization fosters the ordered development of skills and yet still facilitates ease of access to information as needed. This Fourth Edition gives you the tools necessary to perform rigorous and critical analysis of experimental data and the insight to know when to use them.

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600

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CRC Press

Published Date

ISBN 10

0849322146

ISBN 13

9780849322143

Combustion Toxicology

By: Shayne C. Gad,Harold L. Kaplan

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Combustion Toxicology

By: Shayne C. Gad,Harold L. Kaplan

Combustion toxicology is a recent, applied science, the ultimate purpose of which is to reduce casualties from smoke inhalation. The present volume attempts an unbiased presentation of the state of the field. The authors have identified the misconceptions and unsupported conclusions in the literature, differentiating between fact and hypothesis and present the reader with an account of what is really known about the toxicity of smoke produced by materials. They also recommend an approach to evaluating the toxicity of combustion products.

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234

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CRC Press

Published Date

ISBN 10

1439805326

ISBN 13

9781439805329

Safety Evaluation of Pharmaceuticals and Medical Devices

International Regulatory Guidelines

By: Shayne C. Gad

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Safety Evaluation of Pharmaceuticals and Medical Devices

International Regulatory Guidelines

By: Shayne C. Gad

The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.

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135

Publisher

Springer Science & Business Media

Published Date

ISBN 10

1441974490

ISBN 13

9781441974495

Statistics and Experimental Design for Toxicologists, Third Edition

By: Shayne C. Gad

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Statistics and Experimental Design for Toxicologists, Third Edition

By: Shayne C. Gad

This book serves as a primary text for students of pharmacology, toxicology, and biology, and as a practical handbook to support the daily operations of the toxicology laboratory and researcher. This edition retains the structure of earlier editions, but has been extensively revised to provide both the student and the working toxicologist with the necessary tools for the rigorous and critical design of studies and analysis of experimental data. Assuming only basic mathematical skills as a starting point, Statistics and Experimental Design for Toxicologists provides a thorough and exhaustive introduction to the statistical methods available to and used in the discipline. A worked, practical example from the field is provided for each technique presented. Written from a toxicologist's perspective, this book provides both the methodological tools necessary to analyze experimental toxicology data and the insight to know when to use them.

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456

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CRC Press

Published Date

ISBN 10

0849331382

ISBN 13

9780849331381

Acute Toxicology Testing

By: Shayne C. Gad,Christopher P. Chengelis

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Acute Toxicology Testing

By: Shayne C. Gad,Christopher P. Chengelis

Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test designs and reviews their development and objectives. Acute Toxicology Testing, Second Edition will interest not only workers in the pharmaceutical industry, but also researchers and students in toxicology and public health.Key Features* Over 100 tables summarizing and interpreting results* Complete coverage of all major test designs and their limitations and advantages* Current status of alternative test designs and models

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561

Publisher

Academic Press

Published Date

ISBN 10

008052592X

ISBN 13

9780080525921

Safety Evaluation in the Development of Medical Devices and Combination Products

By: Shayne C. Gad,Marian G. McCord

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Safety Evaluation in the Development of Medical Devices and Combination Products

By: Shayne C. Gad,Marian G. McCord

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314

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CRC Press

Published Date

ISBN 10

1439809488

ISBN 13

9781439809488

Nonclinical Drug Administration

Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems

By: Shayne C. Gad,Charles B. Spainhour

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Nonclinical Drug Administration

Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems

By: Shayne C. Gad,Charles B. Spainhour

Reviews the principles of dosing route selection and calculation of maximum dose of drug that can be administered by route and model species Describes techniques on how to achieve highly selective administration of a drug to a specific therapeutic target Covers techniques on how to calculate necessary systemic exposure for the much higher safety testing requirements—and tricks to achieving such systemic exposure Includes a compendium of useable nonclinical formulation vehicles and excipients, with maximum tolerable levels by route, species, and study duration and how to develop nonclinical formulations that work

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Page Count

421

Publisher

CRC Press

Published Date

ISBN 10

1466502592

ISBN 13

9781466502598

The Selection and Use of Contract Research Organizations

By: Shayne C. Gad

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The Selection and Use of Contract Research Organizations

By: Shayne C. Gad

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your

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189

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CRC Press

Published Date

ISBN 10

0203634012

ISBN 13

9780203634011

Non-Animal Techniques in Biomedical and Behavioral Research and Testing

By: Michael Kapis,Shayne C. Gad

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Non-Animal Techniques in Biomedical and Behavioral Research and Testing

By: Michael Kapis,Shayne C. Gad

Non-Animal Techniques in Biomedical and Behavioral Research and Testing features the contributions of noted experts describing the application of non-animal methods in a wide variety of research and testing situations, including computer modeling/graphics, protein sequence analysis, behavioral analysis, drug design/testing, cosmetic and household products testing, toxicological testing, clinical testing, chemical identification and analysis, and disease investigations. Many of the alternatives covered have applications in behavioral as well as biomedical research and testing. Topics examined include in vitro techniques, molecular genetics, structure-activity relationships, physicochemical methods, computer-assisted drug designs, nutrition, epidemiology, autopsies, neural networks, ethology, image scanning devices, and medical microbiology. Future applications for non-animal methods are also explored. The book will appeal to toxicologists, pharmacologists, cosmetic and household product researchers, epidemiologists, medical microbiologists, biopsychiatrists, biomedical and psychological educators, biochemists, molecular geneticists, and other scientists interested in alternative testing methods.

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288

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CRC Press

Published Date

ISBN 10

1439810907

ISBN 13

9781439810903

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

By: Shayne C. Gad

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Integrated Safety and Risk Assessment for Medical Devices and Combination Products

By: Shayne C. Gad

While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

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496

Publisher

Springer Nature

Published Date

ISBN 10

3030352412

ISBN 13

9783030352417

In Vitro Toxicology, Second Edition

By: Shayne C. Gad

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In Vitro Toxicology, Second Edition

By: Shayne C. Gad

Toxicology has made tremendous strides in the sophistication of the models used to identify and understand the mechanisms of agents that can harm or kill humand and other higher organisms. Non-animals or in vitro models started to gain significant use in the 1960s. As a result of the increased concern over animal welfare, economic factors, and the need for greater sensitivity and understanding of mechanisms, interest in in vitro^n models has risen. This volume demonstrates that there now exists a broad range of in vitro models for use in either identifying or understanding most forms of toxicity. The availability of in vitro models spans both the full range of endpoints (irritation, sensitization, lethality, mutagenicity, and devlopmental toxicity) and the full spectrum of target organ systems (skin, eye, heart, liver, kidney, nervous system, etc.). Chapters are devoted to each of these speciality areas from a perspective of presenting the principal models and their uses and limitations. Chapters that overview the principles involved in the general selection and use of models, and that address the issues of safety concerns and regulatory acceptance of these methods are also included.

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Page Count

419

Publisher

CRC Press

Published Date

ISBN 10

1560327693

ISBN 13

9781560327691

Safety Pharmacology in Pharmaceutical Development and Approval

By: Shayne C. Gad

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Safety Pharmacology in Pharmaceutical Development and Approval

By: Shayne C. Gad

The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Con

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207

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CRC Press

Published Date

ISBN 10

0203499182

ISBN 13

9780203499184

Contract Research and Development Organizations-Their History, Selection, and Utilization

By: Shayne C. Gad,Charles B. Spainhour,David G. Serota

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Contract Research and Development Organizations-Their History, Selection, and Utilization

By: Shayne C. Gad,Charles B. Spainhour,David G. Serota

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.

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515

Publisher

Springer Nature

Published Date

ISBN 10

3030430731

ISBN 13

9783030430733

Contract Research and Development Organizations

Their Role in Global Product Development

By: Shayne C. Gad,Charles B. Spainhour

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Contract Research and Development Organizations

Their Role in Global Product Development

By: Shayne C. Gad,Charles B. Spainhour

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.

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Page Count

213

Publisher

Springer Science & Business Media

Published Date

ISBN 10

146140049X

ISBN 13

9781461400493

Safety Pharmacology in Pharmaceutical Development

Approval and Post Marketing Surveillance, Second Edition

By: Shayne C. Gad

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Safety Pharmacology in Pharmaceutical Development

Approval and Post Marketing Surveillance, Second Edition

By: Shayne C. Gad

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions. Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.

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Page Count

217

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CRC Press

Published Date

ISBN 10

1439845670

ISBN 13

9781439845677

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

By: Shayne C. Gad,Stephanie M. Taulbee

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

By: Shayne C. Gad,Stephanie M. Taulbee

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.

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CRC Press

Published Date

ISBN 10

0849301378

ISBN 13

9780849301377

Safety Evaluation of Medical Devices

By: Shayne C. Gad

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Safety Evaluation of Medical Devices

By: Shayne C. Gad

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

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Page Count

576

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CRC Press

Published Date

ISBN 10

1439876088

ISBN 13

9781439876084

Drug Safety Evaluation

By: Shayne Cox Gad

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Drug Safety Evaluation

By: Shayne Cox Gad

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

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