pharmacokinetic

“Approval was based on a pivotal phase II prospective, open-label pharmacokinetic (PK) and safety study using maximum clot firmness (MCF) as a surrogate endpoint for hemostatic efficacy.”

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“These studies, called pharmacokinetic and pharmaco-dynamic studies, offer subjects essentially no chance for medical benefit and pose at least some risks, and to that extent are inconsistent with the subjects 'medical interests.”

The Ethics of Clinical Research

“DRUGDEX provides dosing information, pharmacokinetic parameters, cautions, drug interactions and clinical applications of medications.”

Poison Control Hotline Staff

“The drug has been "well tolerated with a good pharmacokinetic profile," it said in the statement.”

The Wall Street Journal: Glenmark Sells Rights to New Drug to SanofiGlenmark Sells Rights to New Drug to Sanofi

“The medical/legal findings in this study, causal or not, are horrendous and therefore it is important that the suggested epidemiological, pharmacokinetic and animal studies be performed.”

Simon & Schuster: The Panic Virus

“Multiple dose pharmacokinetic study of Meropenem in young infants”

Clinical Trials

“Before Tox21, physiologically based pharmacokinetic (PBPK) models, toxicogenomics, and related approaches were already making risk assessment more mechanistically based.”

Toxicity testing- new dimensions

“For example, physiologcally-based pharmacokinetic models or PBPK models are a computer-based or "in silico" method of predicting how a contaminant might behave in a living system.”

Animal testing alternatives

“But I still had trouble reconciling the fact that somatin was legal, and poured billions of credits into PHC's and AVia's coffers, while caak, which accomplished the same pharmacokinetic effects with fewer and less severe side effects, but was organic and couldn't be synthesized, was illegal in NorAm.”

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