| Description |
1 online resource (vi, 258 pages) : illustrations |
| Contents |
Frontmatter -- Introduction / Alberto Lodola, Jeanne Stadler -- The Regulatory Environment / Claudio Bernardi, Marco Brughera -- Toxicological Development: Roles and Responsibilities / Franck Chuzel, Bernard Ruty -- Contract Research Organizations / Maurice Cary -- Safety Pharmacology / Claudio Arrigoni, Valeria Perego -- Formulations, Impurities, and Toxicokinetics / Claude Charuel -- General Toxicology / Alberto Lodola -- Genetic Toxicology / Peggy Guzzie-Peck, Jennifer C Sasaki, Sandy K Weiner -- Developmental and Reproductive Toxicology / Jeanne Stadler -- Data Analysis, Report Writing, and Regulatory Documentation / Monique Y Wells -- Risk Management / Alberto Lodola -- Index |
|
Introduction / Alberto Lodola and Jeanne Stadler -- The regulatory environment / Claudio Bernardi and Marco Brughera -- Toxicological development : roles and responsibilities / Franck Chuzel and Bernard Ruty -- Contract research organizations / Maurice Cary -- Safety pharmacology / Claudio Arrigoni and Valeria Perego -- Formulations, impurities, and toxicokinetics / Claude Charuel -- General toxicology / Alberto Lodola -- Genetic toxicology / Peggy Guzzie-Peck, Jennifer C. Sasaki, and Sandy K. Weiner -- Developmental and reproductive toxicology / Jeanne Stadler -- Data analysis, report writing, and regulatory documentation / Monique Y. Wells -- Risk management / Alberto Lodola |
| Summary |
This book describes, with references to key source materials, €the background to, and conduct of, the principal nonclinical studies€that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drugs -- Toxicity testing
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Drugs -- Side effects.
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Drug Evaluation, Preclinical -- standards
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Drug-Related Side Effects and Adverse Reactions
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Toxicity Tests -- standards
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MEDICAL -- Pharmacology.
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Drugs -- Side effects
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Drugs -- Toxicity testing
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| Form |
Electronic book
|
| Author |
Lodola, Alberto.
|
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Stadler, Jeanne.
|
| ISBN |
9780470909911 |
|
0470909919 |
|
9780470909904 |
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0470909900 |
|
1283072238 |
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9781283072236 |
|
