Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

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PDI Blog

What is PK Modeling?

Monday, November 21, 2011

Are you trying to figure out how to take advantage of Computer PK Models in drug development? Pharmacokinetics is not rocket science; it’s far more complex. So how well can they do at actually predicting drug delivery and disposition?

There are lots of skeptics and you can’t blame them for their opinions.  However the computer is not the limitation.  People need to feed them their information and interpret what comes out.  When it comes to modeling biological processes such as absorption, distribution, metabolism and excretion, people have to understand more than the mechanics of the model.  They have to understand how all these complex living processes interact.

Each of the factors affecting absorption from the GI tract have to be taken into account.  These may include stomach acid secretion, food and drink intake, gastric emptying rate, timing and level of pancreatic secretions, bile secretions, mucous thickness and viscosity, intestinal motility, pH, efflux pump expression, cellular damage, drug particle size, intrinsic dissolution, and the list goes on.  PK modeling software packages can address these processes and use disintegration, dissolution, and transcellular diffusion as inputs. But, is it good enough?

Take a look at our recent article “What is PK Modeling” in our Resource Center to get some in-depth answers.

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