Pharmacokinetic

Early phase studies are for learning a new drug’s safety profile, dose, route of administration, dosing frequency to optimize the efficacy potential of the molecule. Pharmacokinetic (PK) data, that is, information on what the body does to the drug, drive key decisions for the development process at this stage. We, at Inference, specialize in these early development studies. These studies require optimal collection of PK data and appropriate modeling for reaching key decisions.

• Protocol Review – We can provide both strategic and tactical suggestions on the PK section of the protocol. The collection of PK data, for plasma or urine or both, not only must be such that the trial objectives can be addressed, but also they need to be looked at with a view of the eventual regulatory submission where additional questions about the drug’s absorption, distribution, metabolism and excretion are well documented.
• Non-compartmental Analysis – We have resources with deep experience in PK analysis. Our pharmacokineticist uses WinNonlin to derive the pharmacokinetic parameters according to the methodology specified in the Pharmacokinetics plan or Statistical Analysis Plan (SAP).
• PK/PD Modeling – Often dosing and go/no-go decisions depend on a favorable relationship between clinical outcomes and a compound’s PK profile. We have extensive experience in modeling this relationship – with biomarker, efficacy and safety data.
• POP PK analysis and other Modeling – We also have experience in performing non-linear modeling for Population PK analysis. Our software of choice is Phoenix NLME.