Pharmacokinetic (PK) analysis is the study of how a drug reacts to or interacts with the human body. Analyses can be produced from looking at:

• Absorption
• Distribution
• Elimination
• Metabolism
• The relationship between time and plasma drug concentration
• The impact of other covariates on drug concentrations

PK studies can inform investigators of optimal dose selection or the need for dose adjustment, as well as therapeutic drug monitoring.

PK analysis can be provided in the context of a full clinical study, integrating with in-house statistics and programming teams developing and delivering in line with all pre-planned and PK-specific deliveries. PK support can also be delivered as a stand-alone service, where our team will work with external stakeholders to deliver to a high-quality standard using MAC’s and/or external processes.   MAC’s PK specialists derive relevant PK parameters using non-compartmental data analysis in industry-standard software (Phoenix WinNonlin), and (if required) will work with statistical programming to develop high quality outputs and analyses. Individual stand-alone PK analyses and reports can also be produced.

Pharmacodynamic (PD) analysis quantifies the relationship between drug exposure and pharmacologic or toxicologic responses. MAC’s statistics team can work to incorporate all PK and PD parameters for your product, compound, or study, exploring the effect of different dose levels on individual PD parameters over time.

MAC provides the following as standalone services or within the context of a full clinical study:

• Input into study design
• Non-compartmental data analysis
• Interim PK reports and summaries, both blinded and unblinded, to support early-phase research
• End-to-end PK input, from protocol development to final case study report (CSR)
• Statistical analyses, including:
  
  • PK/PD linear and non-linear mixed modelling approaches
  • Simulation techniques
  • Bioequivalence
  • Bioavailability
  • Dose-proportionality
  • Food-effect
  • Analysis of the relationship between PK and PD