Drug Safety Evaluation 2nd Edition by Shayne Cox Gad ISBN 0470253169 9780470253168

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Product details:

ISBN 10: 0470253169

ISBN 13: 9780470253168

Author:  Shayne Cox Gad 

Drug Safety Evaluation 2nd Edition: 

The updated and expanded safety guide to all aspects of the drug development process

Drug Safety Evaluation, Second Edition 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.

This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory requirements as well as pharmaceutical and technological developments. Drawing upon more than twenty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems.

Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are:

• 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

More pertinent and practical than ever to the industry, Drug Safety Evaluation, Second Edition provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

 

Drug Safety Evaluation 2nd Edition Table of contents:

• Chapter 1: The Drug Development Process And The Global Pharmaceutical Marketplace
• Chapter 2: Regulation Of Human Pharmaceutical Safety: Routes To Human Use And Market
• Chapter 3: Data Mining: Sources Of Information For Consideration In Study And Program Design And In Safety Evaluation
• Chapter 4: Screens In Safety And Hazard Assessment
• Chapter 5: Formulations, Routes, And Dosage Regimens
• Chapter 6: Nonclinical Manifestations, Mechanisms, And End Points Of Drug Toxicity
• Chapter 7: Pilot Toxicity Testing In Drug Safety Evaluation: MTD And DRF
• Chapter 8: Repeat-Dose Toxicity Studies
• Chapter 9: Genotoxicity
• Chapter 10: QSAR Tools For Drug Safety
• Chapter 11: Immunotoxicology In Drug Development
• Chapter 12: Nonrodent Animal Studies
• Chapter 13: Developmental And Reproductive Toxicity Testing
• Chapter 14: Carcinogenicity Studies
• Chapter 15: Histopathology In Nonclinical Pharmaceutical Safety Assessment
• Chapter 16: Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment
• Chapter 17: Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation
• Chapter 18: Safety Pharmacology
• Chapter 19: Special Concerns For The Preclinical Evaluation Of Biotechnology Products
• Chapter 20: Safety Assessment Of Inhalant Drugs And Dermal Route Drugs
• Chapter 21: Special Case Products: Imaging Agents
• Chapter 22: Special Case Products: Drugs For Treatment Of Cancer
• Chapter 23: Pediatric Product Safety Assessment
• Chapter 24: Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology
• Chapter 25: Occupational Toxicology In The Pharmaceutical Industry
• Chapter 26: Strategy And Phasing For Nonclinical Drug Safety Evaluation In The Discovery And Development Of Pharmaceuticals
• Chapter 27: The Application Of In Vitro Techniques In Drug Safety Assessment
• Chapter 28: Evaluation Of Human Tolerance And Safety In Clinical Trials: Phase I And Beyond
• Chapter 29: Postmarketing Safety Evaluation: Monitoring, Assessing, And Reporting Of Adverse Drug Responses (ADRs)
• Chapter 30: Statistics In Pharmaceutical Safety Assessment
• Chapter 31: Combination Products: Drugs And Devices
• Chapter 32: Qualification Of Impurities, Degradants, Residual Solvents, Metals, And Leachables In Pharmaceuticals
• Chapter 33: Tissue, Cell, And Gene Therapy

 

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