Drug Safety Evaluation
by Shayne Cox Gad /
2009 / English / PDF
4.5 MB Download
Drug Safety Evaluation
Drug Safety Evaluation
Second Edition
Second Edition
Shayne Cox Gad
Shayne Cox Gad
The updated and expanded safety guide to all aspects of the drug
development process
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.
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.
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:
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
Acute toxicity testing in pharmaceutical safety evaluationGenotoxicity
GenotoxicitySafety assessment of inhalant drugs
Safety assessment of inhalant drugsImmunotoxicology in pharmaceutical development
Immunotoxicology in pharmaceutical developmentLarge animal studies
Large animal studiesEvaluation of human tolerance and safety in clinical trials
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.
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.
