You say ‘Tomato’, I say ‘Tomahto’
ACoP10 Session
Session
ACoP
The Case of the Crisis of Confidence:
- Jim Rogers sued Eric Jordie for improperly labelling prediction intervals in his VPC as confidence intervals. Judge Kowalski found Dr. Jordie guilty with extenuating circumstances, given that the ISoP guidance on model evaluation is what steered him wrong! Eric was held in contempt of court for attitude problems
The Case of the Pharmacometrician’s Pitiful Planning:
- France Mentre sued Jin Jin for not providing pharmacometric input into the sample size of a clinical trial for which PK was a key component. This case was decided by a jury, the members of which were randomly selected from the audience. While the jury (led by Matt Zierhut) found Jin not guilty, they suggested that she visit a clinical site participating in the Pop PK substudy to help her appreciate the challenges sites face, and to attend a seminar on persuasive presentations with Pete Bonate to help her convince the team to get the necessary samples next time.
The Case of the Extrapolated Prediction:
- Lei Nei sued Chao Liu for making drug development decisions based solely on extrapolated predictions. Specifically, Chao had recommended a clinical dose for Formulation Y based on an exposure-response model for Formulation X and a PK model for Formulations X and Y. Judge Kowalski dismissed the case given then the Chao was using well-established pharmacometric approaches. However, he reminded Chao to explicitly acknowledge his assumptions when making extrapolated predictions.
The Case of the Not So Confirmatory Conclusion:
- Brian Smith sued Nag Chematuri for overstating the significance of covariate effects in a population pharmacokinetic analysis (using p-values for exploratory analysis). Nag had tested 34 covariates on all of the structural parameters in his PK model, without any adjustment for multiple testing. Judge Kowalski found Nag guilty, but the case was appealed to the Supreme Court where Justice Brian Corrigan overruled with a resounding GUILTY verdict…. When Judge Kowalski pointed out that his verdict was actually the same, Justice Corrigan got a big laugh by saying “I know, but I’ve been wanting to overrule you for 25 years!!”