Bioequivalence and Bioavailability Forum

Hi Sree,

A good place to start is the book by Chow and Liu "Design and analysis of bioavailability and bioequivalence studies".
It describes a way of doing the BE-ANOVA without model fitting, and it also -and this is where I think you easily could gets started with Excel- tells how to derive the statistics without ANOVA, but using t-test in stead.
As it happens, the two methods should ideally give the same results ( in terms of p-values), but they do not in case of imbalance, where the t-test approach gives you p-values that correspond to ANOVA based on model fits with type III sums of squares and they are generally accepted.
All in all, it is a jungle out there. In order to calculate your BE-statistics for a standard 2,2,2-BE study you can thus use a linear model* and play with factor inclusion to obtain the ANOVA (with for example type III SS), or you can do the ANOVA without a model fit by way of the reference above, or you can do it all without ANOVA and just do a series of t-tests (and get p-values corresponding to type III SS).

Best regards
EM.


*: You can even use a (linear) mixed model with subjects as random factor.

Dear Sree,

welcome to the forum!

❝ Can anybody tell me how to do PK & Stat analysis of BA/BE in MS-Excel? Whether is it really possible to calculate all the parameters in Excel sheet?

Yes it is possible – if you are talking about noncompartmental analysis (NCA) only, and keep the BE design simple (parallel groups, 2×2 cross-over). You have to be quite experienced to deal with higher-order cross-overs. Don’t even think about evaluating a replicate design study.

Now for the bad part – IMHO it is practically impossible to validate an NCA/BE-analysis in Excel. OK, you can do  everything  something in Excel – but only for fun (actually I have workbooks for all these types of studies: at the right is an example as quoted by ElMaestro in his post); don’t think about using it in a regulated environment (IMHO, you will not survive the inspection).

In the future please search before posting.
You would have found a couple of posts flashing a bright warning, e.g.,

• ID #2200
  
• ID #3062

If you are short in money, why don’t you consider the package bear for ? The current version supports NCA for single/multiple dose, and BE for parallel, 2×2 cross-over, and replicate designs.
Resources (freeware under the GNU-license): (current v2.9.1 2009-06-26), bear (current v2.4.0 2009-07-21).

Remember that you have to validate all software - this requirement is applicable to commercial software as well.
I hope you do not want to perform compartmental PK in Excel - I would consider it simply impossible (Excel’s solver is just a piece of s…t).
There’s an add-on (PK Solutions) marketed by SummitPK. But keeping the well-documented deficiencies of Excel in mind…

❝ PL suggest me any reference to the calculations?

What do you mean by that? I would suggest reading some books. A selection is given here.