Streamlining and Supporting Drug Development

Rosa’s PK/PD and Clinical Pharmacology Services include:

• PK/PD modeling, including small molecules and biologics or special populations
• Mechanistic PK/PD modeling, using both PK/PD and PhysioPD™ models
• Analysis of unusual properties; e.g., autoinduction or target-mediated disposition
• Simulations to define the best study design and proper dose for a successful outcome
• Study design, protocol and report writing, IND and NDA submissions
• NCA Analyses, model documentation, and related regulatory correspondence

PK/PD Applications

Pharmacokinetic/pharmacodynamic (PK/PD) models represent the mathematical and statistical relationships between dose and dose regimen, plasma drug concentration, and drug effect

In silico PK/PD simulations are the industry standard for (1) exploring future trial designs, (2) weighing alternative hypotheses for pharmacokinetics, drug effects, and population variability, and (3) designing both informative exploratory trials and conclusive confirmatory trials.

PK/PD models are well-suited to inform key scientific questions and program decisions, like:

• Doses and regimens in trials, ranging from First-in-Man to Phase III
• Number of study arms, study group sizes, and patient inclusion/exclusion criteria
• Comparators, endpoints, and measurement intervals
• Measures for quantifying and improving the probability of trial success
• In vivo studies that can materially reduce the risk of costly decisions
• Go/no-go decisions

See our cases for actual applications.