Comprehensive Guide to Toxicology in Preclinical Drug Development
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Description: A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guidelines for safety evaluation and present both traditional and nontraditional toxicology models. By incorporating the latest research in this area and featuring real-life examples and scenarios, this reference is a complete and practical 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. Incorporates real-life case studies and examples and offers readers a practical resource that outlines day-to-day activities and experiences in preclinical toxicology.
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All the information you need in one place! Each Study Brief is a summary of one specific subject; facts, figures, and explanations to help you learn faster.
List price: $199.95
Copyright year: 2013
Publisher: Elsevier Science & Technology Books
Publication date: 11/2/2012
Size: 8.75" wide x 11.25" long x 2.00" tall
MPI Research, Mattawan, MI USA
|Development of Preclinical Formulations for Toxicology Studies|
|Acute, sub-acute and chronic toxicity testing|
|Best Practice in Toxicologic Pathology|
|Molecular pathology in preclinical Toxicology|
|The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials|
|Developmental & Reproductive Toxicology|
|Toxicity Studies to Support Clinical Trials in Pediatric Population|
|Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay|
|Carcinogenicity Evaluations using Genetically Engineered Animals|
|Current Strategies for Abuse Liability Assessment of New Chemical Entities|
|Impact of product attributes on preclinical safety evaluation|
|Preclinical Development of Monoclonal Antibodies|
|Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)|
|Preclinical Development of Oncology Drugs|
|Safety Evaluation of Ocular Drugs|
|Preclinical toxicology of vaccines|
|Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics|
|Preclinical Development of Botanical Drugs|
|Chinese Drug Regulations|
|Biostatistics for Toxicologists|
|Study Director and Preclinical Study Monitoring Role|
|Use of Imaging for Preclinical Evaluation|
|Metabolics in Toxicology|
|Toxicogenomics in Drug Development|
|Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm to Toxicology in Preclinical Drug Development|