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May I add a couple of comments regarding the use of the term "toxicokinetics".
I would (as others on this site) define toxicokinetics (TK) as PK in support of
toxicity studies and that it is associated with limited blood sampling to assess
systemic exposure (Cmax and AUC) within a dosing interval.
The extent of systemic exposure is used to quantify sex-related differences,
dose proportionality and stationarity (time invariance). Thus, the scope of TK
is quite narrow.
Typically, much higher doses are used in TK studies so that capacity-limited
process are often identified.
Discriminating between PK and TK assists in the writing of regulatory summaries
and I can confirm that this is acceptable to at least one MHRA reviewer.
When relating TK to safety or efficacy, it doesn't matter whether one describes
this as TK/PD or TK/TD, as long as the abbreviations are well defined.
Of course, in supporting the use of TK as a convenient descriptor I must
my interest as chairman of the TKDG!
The next TKDG meeting is hosted by AstraZeneca at Alderley Edge on 28th
with a programme including TK of biologicals and agrochemicals, current
future approaches to TK as well as an update on dried-blood spot and micro
sampling. Please contact me directly charlie.brindley.-at-.kinetassist.com for
further information (all welcome, even TK deniers).
Chairman, Toxicokinetic Discussion Group (TKDG)
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