BioanalysisVol. 2, No. 8 EditorialFree AccessDoes validation stagnate innovation?Dennis A SmithDennis A SmithPharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Sandwich, Kent, UK. Search for more papers by this authorEmail the corresponding author at dennis.a.smith@pfizer.comPublished Online:18 Aug 2010https://doi.org/10.4155/bio.10.63AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Plasma samples are vulnerableAt the end of 1999, I remember the planning we had to do to ensure that the millennium bug did not wreak havoc in the Department of Drug Metabolism, Pfizer Inc., UK. When we analyzed the vulnerable items, most would be powered down (switched off) over the holiday break. What was left was the freezer and cold room network, protecting countless samples. Of course this had a microprocessor doing something and obviously it couldn’t be switched off. Our contingency plan was for Dick Venn, the senior analyst, to travel into the laboratories and check all was well early on New Years day. The plan, which had to be forwarded to a global office in New York, USA, detailed the costs of failure and the figure was very high, if, for example, the stored samples thawed in terms of study repeats. We had fun hiding in the report that in the event of Dick Venn’s car suffering catastrophic processor failure he would use his year 2000 (Y2K)-resistant bicycle.Plasma (and urine) samples don’t ship or fly wellIn another time and place (many years ago) I had to accompany some dog urine samples to the USA. They travelled in the hold and I had a seat. The plan was for me to pick them up and drop them off for analysis on my way to a conference. All paperwork was in place, but the amount of cardice was insufficient to ward off the 30°C heat we landed in, and the delay in reaching the gate and offloading the cargo. My slightly thawed samples arrived last on the luggage carousel to the delight of every fruit dog, drugs dog or whatever security dog in the building. US security thought for a few minutes that they had finally nailed Mr Big. What’s more the samples were now worthless as the validation was for frozen urine. The same would apply to plasma, but maybe the dogs would have had a calmer day.Blood is better than plasmaWell certainly not worse. We used plasma in the days of gas chromatography and early HPLC–UV because it was a cleaner matrix. Pharmacokinetics relies on blood flow values to determine such things as hepatic extraction, thus to determine these values extra experiments such as blood partitioning are needed. Moreover, instability of a drug or metabolite is problematic to plasma preparation. Incidentally, you also need mains electricity to prepare plasma so a field trial in the wrong place cannot easily separate the blood. Why can we not have a system that eliminates all the problems of producing plasma, storing it, shipping it, and that has discrete easy labelingI attended a conference on toxicokinetics approximately 4 years ago. I say approximately because I now remember things as last year only to find I did them 2 years ago. What I heard really excited me. To excite me with technology is difficult. I do not really enjoy laboratory tours anymore as I am unable to distinguish one white box from another (oh for a mass spectrometer with proper magnets). It was an answer to the above–dried blood spots. Here was something that completely got round all the problems I had witnessed and many less funny ones. The possibilities seemed endless and short of being able to fax the dried blood spot sheets to the analytical laboratory, I felt we were on the brink of a little revolution. The presenters described how they had validated the technology and were looking for areas to introduce it, but partner lines were worried about impact.Validation is a permanent stateWhilst not a true analyst my contact is regular, but infrequent, with the scientists working on this technology. What began to dismay me was that, even though there was high interest amongst the analytical section and widespread validation going on; no-one seemed to be adopting it. Why was this? The years were passing by and the freezers getting fuller, the labels gradually and damply falling off to make the samples useless. Plasma sample shipping costs were rising and yet the best we could do was some more validation ‘in our hands with our compounds’. The impact on global warming and carbon footprint of all those freezers and cold rooms was mounting day by day. I began to develop a conspiracy theory that someone high up somewhere profited hugely from plasma samples. Moreover, going to the simpler, better system of blood spot analysis would create financial mayhem to his empire. If it wasn’t a Mr Big (remember he wasn’t caught in the thawed urine massacre) then who was it? Is it just that to innovate nowadays requires so many parties to agree and with so many naysayers it is easier to stay in validation mode? Does working across many disciplines mean that technical breakthroughs are very difficult, simply because the aversion to change rises? If so I suggest the following formula: ▪ Resistance to new technology = number of disciplines possibly affected2For instance, it is very easy to consult with someone and be told ‘not sure’, but would the US FDA, EMA, Medicines and Healthcare products Regulatory Agency, US Environmental Protection Agency, Alcohol, Tobacco and Firearms (ATF) or Royal Automobile Club (RAC; well the ATF and the RAC may not need to be involved) accept this? Well of course they would: it is a validated certifiable assay system applicable to samples from discovery, toxicity and the clinic. That is why this issue is so important. Have I missed that everyone is doing it and did not tell me? Did a crucial validation step fail and end in tears? Or is it like I write? If so, I want you to spill blood and spot it and make this the sample system of this decade – NOW.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.FiguresReferencesRelatedDetailsCited ByNew bioanalytical technologies and concepts: worth the fuss?Dennis A Smith13 August 2013 | Bioanalysis, Vol. 5, No. 16A dried blood spot update: still an important bioanalytical technique?Neil Spooner16 April 2013 | Bioanalysis, Vol. 5, No. 8The best of Bioanalysis 2010Brian Booth & Howard Hill14 July 2011 | Bioanalysis, Vol. 3, No. 14 Vol. 2, No. 8 Follow us on social media for the latest updates Metrics History Published online 18 August 2010 Published in print August 2010 Information© Future Science LtdFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download