Pharmacometrics - Pharmacokinetic and pharmacodynamic services

Pharmacokinetics (PK) and Pharmacodynamics (PD) explore the effects of drugs on organisms and vice versa. Pharmacokinetics describes the absorption, distribution, metabolism and excretion of a particular drug. Pharmacodynamics is the study of biochemical and physiological effects of drugs on the human body. Both provide insights for further drug development (dosing, benefits, adverse effects). Furthermore, these insights are used for guiding input and decision making by regulatory authorities.
BioNotus offers extensive pharmacometric services for groundbreaking drug development. Our services include:
• Non-compartmental analysis
• Population pharmacokinetics
• PKPD modelling
• Physiology-based pharmacokinetic (PBPK) modelling
• Mechanistic modelling

Non-compartmental analysis

In contrast to compartmental methods - which describe the body as interconnected, homogeneous compartments – non-compartmental analysis (NCA) methods are model-independent.
Non-compartmental analysis (NCA) methods do not assume the existence of body compartments. A NCA implies the use of algebraic equations to estimate pharmacokinetic parameters, resulting in a more straight-forward analysis.
As compared to compartmental model-based analysis, NCA’s generally allow for more rapid analysis, implying cost efficiency.

Population Pharmacokinetics (popPK)

Population pharmacokinetics allows to gain insight into the factors (i.e. covariates) explaining inter-individual differences in exposure to equal doses of a specific drug. PopPK models consist of differential equations describing the rates at which concentrations in various body compartments are changing. Such models thus allow estimating population values for key PK parameters along with patient-specific deviations from these population means. Population pharmacokinetic modelling enables key decisions across all phases of drug development. PopPK represents a crucial technique for the further development of personalized medicine.

PK/PD modelling

PK/PD modelling (pharmacokinetic/pharmacodynamic modelling) combines the key disciplines of pharmacokinetics and pharmacodynamics. It integrates PK and PD aspects of drug behavior into a single model of mathematical equations. This eventually implies describing the time course of effect intensity in response to the administration of a clinically relevant drug dose.

Physiology-based pharmacokinetic (PBPK) modelling

During the last decade, physiology-based pharmacokinetic modelling has emerged as a key decision tool in pharmaceutical research and drug development. PBPK implies the mathematical implementation of the body as a set of physiological compartments with defined blood supply to the various compartments. Along with high-resolution and compound-specific in vitro ADME data, PBPK modelling allows for ‘true’ bottom-up prediction of the absorption, distribution, metabolism and excretion of a given drug (candidate).
BioNotus has extensive expertise in physiologically-based pharmacokinetic (PBPK) modelling. Contact us for more information.

Pharmacometrics services

BioNotus offers extensive expertise in various domains of pharmacokinetics, pharmacodynamics as well as modelling and simulation:

+ Non-compartmental analysis
+ Population pharmacokinetics
+ PKPD modelling

+ Physiology-based pharmacokinetic modelling
+ Mechanistic modelling

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