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Bib ID: 158906

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You searched Book & Serials - Bib ID: 158906
NLM Call No. QV771 G123D 2017
ISBN 9781119097396 (hbk.)
Author Gad, Shayne Cox
Title Drug safety evaluation / Shayne Cox Gad.
Edition 3rd ed.
Imprint Hoboken, N.J. : John Wiley & Sons, c2017.
Physical Description xxvii, 886 p. : charts.
Content Note The drug development process and the global pharmaceutical marketplace -- Regulation of human pharmaceutical safety: routes to human use and market -- Data mining: sources of information for consideration in study and program design and in safety evaluation -- Screens in safety and hazard assessment -- Formulations, routes, and dosage regimens -- Nonclinical manifestations, mechanisms, and end points of drug toxicity -- Pilot toxicity testing in drug safety evaluation: MTD and DRF -- Repeat‐dose toxicity studies -- Genotoxicity -- QSAR tools for drug safety -- Immunotoxicology in drug development -- Nonrodent animal studies -- Developmental and reproductive toxicity testing -- Carcinogenicity studies -- Histopathology in nonclinical pharmaceutical safety assessment -- Irritation and local tissue tolerance in pharmaceutical safety assessment -- Pharmacokinetics and toxicokinetics in drug safety evaluation -- Safety pharmacology -- Special concerns for the preclinical evaluation of biotechnology products -- Safety assessment of inhalant drugs and dermal route drugs -- Special case products: imaging agents -- Special case products: drugs for treatment of cancer -- Pediatric product safety assessment (2006 guidance, including juvenile toxicology) -- Use of imaging, imaging agents, and radiopharmaceuticals in nonclinical toxicology -- Occupational toxicology in the pharmaceutical industry -- Strategy and phasing for nonclinical drug safety evaluation in the discovery and development of pharmaceuticals -- The application of in vitro techniques in drug safety assessment -- Evaluation of human tolerance and safety in clinical trials: phase I and beyond -- Postmarketing safety evaluation : monitoring, assessing, and reporting of adverse drug responses (ADRs) -- Statistics in pharmaceutical safety assessment -- Combination products: drugs and devices -- Qualification of impurities, degradants, residual solvents, metals, and leachables in pharmaceuticals -- Tissue, cell, and gene therapy.
Subject Drug evaluation, Preclinical
Subject Drug evaluation
Subject Product surveillance, Postmarketing
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Call Number QV771 G123D 2017
Location CL_Pharmacology_General Book
Copy 1
Status Available
Item Number 1000188924

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