Automated PK processing and reporting

Full run list Data is exported to excel, directly from the mass spec software The only stipulation is that the labels have a set format [In this case “ID_time_” (time in h or min) Input the dose for PK calculation and no further manipulation of the data is required. Everything is automated from here Further functionality is, of course, available and can be built in as required: For example; in the above extract from the full run list, I have tried to trick the processor by changing the 20 min sample to 22 mins to put it out of sequence. I also want to select the dilution samples for the 1 min samples because they are ULQ The first of these tasks is already catered for automatically, the second is a simple manual selection This information plus dose administered is all the you need to tabulate bioanalysis and calculate and tabulate PK 2

Automated Bioanalysis Output _ FULL PAGE More detailed look at tabulation on next slide The data tabulation is generated from a set of serial samples. This sheet also has the capability for sparse sampling regimen e.g. Tissue biopsy or low volume matrices 3

You can see that the 22 min sample has correctly tabulated in both the results table and WNL input data-stream The dilution samples at 1 min (0.017 h) have also been selected, I will demonstrate how that was done on the next page 4

The bioanalysis table has an expand function In the expanded form a number of further functions are accessible – I won’t go into all of these at the moment but two are evident from the illustration……… – 1. in the 3 rd column for each subject, I have selected the “2”nd result i.e. the dilution – 2. I have applied actual samples times. The changed ones automatically colour (orange) and if you look back to the WNL input on the previous slide you will note that the ‘applied ‘ sample times are used where relevant 5

PK results page This sheet is set up to auto tabulate the data from WNL output (as seen below) – The table format is entirely flexible. Indeed you can set it up to customise the parameters you wish to report The PK calculator (bottom right) calculates the PK directly – You can set it up to calculate all PK directly thus no requirement for WNL – The number output is identical (although the illustration below has used different extrapolation methods…(very easy to resolve)) – My non-compartmental PK calculation sheets will additionally calculate absorption rate (Ka) for PO kinetics and distribution rate (Kd) for IV kinetics [not illustrated in this very simple version] 6

Summary Output 7 Again this is entirely customisable to requirements The sheet is also able to collate IV and PO data together for combined summary and bioanalysis etc [not illustrated here]

Automated population of MS Word template 8