Drug Safety Evaluation

The definitive safety guide to all aspects of the drug development process

The third edition of Drug Safety Evaluation continues and expands on the comprehensive resource its predecessors offered 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.

In the new edition, changes and updates reflect the many changes in the scope of products (small synthetic, large protein moieties and cells and tissues), harmonized global and national regulatory requirements, the therapeutic development process, and available technologies to identify and evaluate the relevance of potential patient risks. They address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Drawing upon nearly forty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., carcinogenicity, developmental toxicity, immunogenicity and immunotoxicity) 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:

Data Mining
Acute toxicity testing in pharmaceutical safety evaluation
Genotoxicity
Safety assessment of inhalant drugs
Immunotoxicology in pharmaceutical development
Evaluation of human tolerance and safety in clinical trials
Statistics
Impurity assessment and qualification
QSAR and in vitro alternative methods

Shayne Cox Gad, BS, PhD, DABT,  has more than 38 years of experience in regulatory toxicology, drug and device development, statistics, and risk assessment. He is Principal of Gad Consulting Services, a firm with eight employees and more than 500 clients worldwide in the pharmaceutical and medical  device industries. He is Past President of the American College of Toxicology (ACT), the Roundtable of Toxicology Consultants, and three of the Society of Toxicology s specialty sections. Dr. Gad received the 2008 ACT Lifetime Contribution Award and has authored or edited 47 books (10 with Wley) and more than 350 chapters, articles, and abstracts. Has preparated 110 INDs and 8 NDAs and teaches 3–5 professional education courses a year.