Seda Pharmaceutical Development Service

Seda Pharmaceutical Development Service

Block 21, Alderley ParkAlderley EdgeCheshireSK10 4TG

Pharmacokinetic Modelling

Pharmacokinetic Modelling

Understanding what the concentration of a compound in the body is and how the concentration varies with time (pharmacokinetics) is an essential foundation of modern drug discovery and development. Taking this further and developing an understanding of how these concentrations are driving in vivo effects (biomarkers/efficacy/toxicity) and the time that these concentrations need to be maintained for a positive outcome starts to allow rational decisions to be made about the dose and pharmacokinetics (PK) profile required in patients. This allows a drug developer to answer questions such as:

Do I understand my compound’s in vivo activity? If not, what are the sources uncertainty and how does this affect my development strategy?

What PK profile do I require?

What is my likely therapeutic margin?

What is the best dosing regimen?

What are the optimal (and most cost efficient) designs for my in vivo efficacy studies?

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