Topic 7: Preclinical PK studies Flashcards

1
Q

Data needed to predict the likely PK profile

A
  • LogP
  • Caco-2 cell line permeability
  • microsomal stability assay
  • plasma protein binding drug transport

PK profile from this data is predicted using a series of scaling factors of the PBPK approach which assumes the body is made up of a series of compartments connected by blood flow that corresponds to organ systems

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2
Q

Design of a pre-clinical trial

A
  • CT curve needs 10-15 data points
  • high in frequency soon after dosing, concentrated around CMAX
  • 3 points in the absorption phase
  • Samples should be ranged in a way to provide the most information from each mouse
  • Data used to determine cMax, Cl and AUC
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3
Q

Principles of allometry

A
  • anatomical and physiological parameters between species can be correlated as a power function of body weight
  • found by plotting body mass vs metabolic rate on a log scale and taking the slope
  • Cl human = Clmouse*(weight human/weight mouse)^0.75
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