Pharmacokinetic/Pharmacodynamic Studies in Drug Product Development

Rooibos™: Automated schedule broadcast software for clinical pharmacology studies

“…PK studies are intended to define the time course of a drug and, where appropriate, its major metabolite concentrations in blood and other body compartments. [3] These studies should be performed according to procedural directions at precise times to ensure high reliability. When both PK and pharmacodynamic (PD) data are to be obtained during a clinical pharmacology study, the sampling strategy should be optimized for both PK and PD measures.…”

Recommendations for the development and validation of flow cytometry‐based receptor occupancy assays

“…When combined with pharmacokinetic (PK) data, RO measurements can be used in mechanism-based PK/PD modeling to establish minimal drug thresholds and guide dosing decisions in pre-clinical and early clinical biopharmaceutical development (1). In later stage development, RO assays can be used to verify and monitor the PK/PD relationship in response to changes in the target populations, compound formulation or route of administration.…”

Population Pharmacokinetics of Therapeutic Monoclonal Antibodies: Examples and Estimation Method Performance Differences

“…Even after adjusting for body size, gender was identified as a predictor of CL L , CL T , and V 1 in a small number of studies (Table 1- 5). The effect of gender on the PK of ustekinumab and infliximab was relatively small and not considered to be clinically relevant (36,47).…”

“…One likely reason for the continued success of the clinical development of mAbs is the application and integration of pharmacokinetic (PK) and pharmacodynamic (PD) concepts in all stages of pre-clinical and clinical drug development (3,4). Such implementation of PK/PD modeling and simulation in drug product development provides a rational, scientifically based framework for efficient decision making regarding the selection of potential drug candidates, for maximum information gain from the performed experiments and studies, and for conducting fewer, more focused clinical trials with improved efficiency and cost effectiveness (5). One application of PK/PD concepts in drug development is population PK, which attempts to quantify the typical disposition characteristics and sources of PK variability (such as between-subject, withinsubject, and inter-occasion) within study populations.…”

“…Common practice in the mAb population PK analyses was to evaluate different size covariates during the covariate modeling process to identify which, if any, were the most influential and should remain in the model. Of the different measures of body size, WGT was the most common size covariate included in the final population PK model (Table 1- 5). In most studies, the effect of body size on a PK parameter was modeled using a power function and the exponent in the function was treated as an estimable parameter.…”