Call for in vitro methods for estimating human hepatic metabolic clearance/ stability
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IN VITRO METHOD SUBMITTER
Department/ Faculty/ Institute or other
ADDITIONAL CONTACT PERSON
If different from above:
ESTIMATING HEPATIC METABOLIC CLEARANCE/STABILITY
How many chemicals do you run per year in your test facility using the submitted method?
Which of the following test systems is employed in the in vitro method/ SOP:
If you have used microsomes or S9, what co factors were employed?
Which is the test system configuration:
Short description of system's confuguration
How many days were the cells plated before used in the in vitro experiment ?
Which parameter is measured:
Is the submitted method suitable for determining chemicals with clearance values below 1uL/min/10^6 cells?
Are there any internal standards or reference compounds, for which human in vivo behaviour is known, included in the in vitro method/SOP?
please list the compound(s)
In addition, do you have experimental data for any of the listed compounds that can be disclosed to the EURL ECVAM? If yes, please select the compounds.(list was obtained from Hallifax et al, Pharmaceutical Research (2010), 27: 2150-2161)
In case that a cellular test system is employed in the submitted SOP/ method: Do you have any cytotoxicity data of tested compounds or reference compounds (e.g. Doxorubicin) towards the test system?
please list the compounds for which cytotoxicity data is available
Add a list of relevant bibliographic (scientific) references (maximum 10). Please include - Author (year), Title, Journal Volume, page numbers e.g. Singh N.P., Mcoy M.T., Tice R.R., and Schneider E.L.(1998) A simple technique for quantitation of low levels of DNA damage in individual cells, Experimental Cell Research 175, 184-191
Have these clearance/ metabolic stability data been obtained from incubations of single compound?
Have these clearance/ metabolic stability data been obtain from incubations of a mixture of compounds
Which type of analytical instrument/ detector was employed for sample analysis?
Short description of analytical instrument/detector used:
Are acceptance criteria for the analytical method being used and are they specified in the analytical protocol/ SOP? An example of acceptance criterion could be (for the case of monitoring parent depletion) that the detection limit of the analytical method should be at least 2 times lower than 4% of the actual initial incubation concentration.