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18 Answers 22 Votes
Could salary be used as a surrogate for smoking when sample data are lacking?
In epidemiology cohort studies, information on smoking status is often times lacking for the study sample, which makes it challenging to characterize the effects of other risk factors on endpoints that are causally related to smoking (e.g., lung cancer mortality). Given the strong inverse reported for smoking and income, could salary be used as a surrogate for smoking when direct data are lacking? or would potential relationships between salary other risk factors (e.g., health care access)...
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18 Answers 8 Votes
Is Oxidative Stress sufficient by itself as an indicator and compelling basis for a carcinogenic concern?
Oxidative Stress as a Precursor and Mechanism for Carcinogenicity IARC and others (Smith et al) have identified 10 key characteristics which may be used/considered in the evaluation of carcinogenicity, one of which is oxidative stress. How strong or compelling, if at all, would the data need to be for considering OS as a putative and defensible MOA for carcinogenicity, or would there need to be other tangential/correlative data (e.g., tumors) available. In other words, is OS sufficient by...
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10 Answers 0 Votes
The motivation behind conducting a risk assessment
Hello, I understand the purpose of a chemical risk assessment (e.g., setting safe exposure limits). However, I am wondering, in practical terms, what (aside from regulations) causes agencies to conduct these assessments. Consumer concerns? Potential litigation? Political pressure? In other words, what signals do the EPA and other regulatory agencies get that convinces them to conduct an assessment? Thank you.
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9 Answers 1 Vote
How do you balance privacy and public health in a pandemic?
Digital contact tracing involves a level of surveillance that could make a lot of people uncomfortable, especially given the involvement of large technology companies with spotty records on privacy. However, contract tracing represents one of the most potent methods for combating the pandemic and is only useful if implemented on a wide scale. How do we balance privacy and public health in these times?
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Answer Accepted 1 Answer 0 Votes
For me-too medical devices, on what basis should manufacturers choose biological tests to conduct?
Manufacturers producing a me-too medical device intended for implantation in the human body, conducting a full biocompatibility study including implantation effect that takes more than one year does not seem logical. With the availability of a reference medical device of the same material & intended use, how can the manufacturer choose the required biological tests?
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Answer Accepted 1 Answer 1 Vote
How the drug dosing space and therapeutic level in term of MTD may best be correlated with pharmacokinetics and body metabolic rate in the subject to gain best possible impact and to minimize the toxicity.
when we recommend the dose of antibiotics like oxytetracycline in animals we usually take into consideration the recommended dose on the label but most of the time the therapeutic effect may not be obtained as suspected. As physician we recommend little bit high dose of the drug in some animals for best results which becomes beyond the regulation authorities to justify. Is it possible to recommend the dosing space or dose of the drug flexible including some criteria of considering BMR of the...
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5 Answers 5 Votes
How should exposure durations be scaled from studies in mice and rats to humans?
Time-Scaling for Developmental Toxicity Endpoints How should exposure durations be scaled from studies in mice and rats to humans? Is a 10-day rodent exposure equivalent to a 10-day human exposure during gestation?
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