Bioequivalence and Bioavailability Forum

Dear everyone,

I have updated FARTSSIE to version 2.7, and migrated it (finally) to github:

https://github.com/dndubins/FARTSSIE

It's been a while since I've posted to this forum (oh it has to be years now!) so I thought I would give you a bit of background on where FARTSSIE originated. When I was at Allied Research International Inc., Dr. Richard Moisan trained me as a PK scientist. He was a patient teacher, always with a cigarette in his mouth and a keen eye for science. He was a data purist really, and was passionate in the way he ran and interpreted Phase I and II trials. "If you don't love your job, then get the f**k out" was one of the many phrases he would repeat to us. And by the way, we did love our jobs in the department, especially working for Richard. He would tell us stories about his years at Roche, and about his PhD that took so long because he investigated the effects of aging on pharmacokinetics in rats. "I had to wait until the rats got old", he'd say. When HR left the building, he would smoke inside. He was a character!

One day Richard told me there was a talk he was supposed to give at SoCRA, the Society of Clinical Research Associates. He asked me if I could present in his place. "What would I talk about?" I asked him. I had just come up with a crude Excel spreadsheet to estimate sample size for a 2-way crossover BE trial, so he responded "how about sample size?" I took on the challenge, and adapted the spreadsheet for the talk, presenting it (at the time) as a free alternative to what was available. The talk was fun, and the spreadsheet was born. Richard was amenable to posting it as freeware, although when Cetero Research bought Allied, Murray Ducharme suggested selling it. No, I insisted, this needs to be a free tool, thinking about my students who needed a button to push for their problem sets.

As the regulations changed, along with my role leaving consulting work and teaching full time at UofT, I lost contact with my industry ties. So many good people - Yan Liu, our crazy smart biostatistician, for one. I struggled marginally successfully keeping up with some methods and changes in regulations, but recently finally realized my conception of reference-scaling was at best oversimplified, and not giving proper estimates. Meanwhile, PowerTOST was developed in the language I love, so rather than re-inventing the wheel, I outsourced this method to PowerTOST.

I have received a lot of kind emails about FARTSSIE over the years. If you have a version of it somewhere on your hard drive, please update it to the latest, as I really have made a number of important improvements and corrections. Helmut helped me correct the suggested PowerTOST code.

Richard passed away a while ago now (we all warned him about the chain smoking!). So many stories, so much house wine at the Open Cork restaurant, and so many hysterical conflicts with QA, Richard was without a doubt my favourite mentor. I miss him dearly.

Kind regards,
Dave