Embedded Files
The FDA has launched Project Optimus for oncology drug products
Clinical pharmacology is a vital discipline in drug development, and it involves the study of pharmacokinetics (PK), which explores how drugs are absorbed, distributed, metabolized, and eliminated within the body (ADME), providing insights into the drug's concentration-time profile and bioavailability. Clinical pharmacology also encompasses pharmacodynamics (PD), which investigates the relationship between drug concentration and its effects on biological systems, including target engagement, biomarker responses, and therapeutic outcomes.
Through pharmacokinetic-pharmacodynamic (PK-PD) modeling, clinical pharmacologists can predict drug responses, optimize dosing regimens, and tailor treatments to individual patient characteristics, maximizing therapeutic benefits while minimizing adverse effects.
Regulatory agencies rely on clinical pharmacology data to evaluate the pharmacokinetic and pharmacodynamic profiles of new drugs, assess their benefit-risk profiles, and make informed decisions regarding drug approval, labeling, and post-marketing requirements.
AreteVolo's offers,
First-in-Human (FIH) study design including starting dose selection and enabling concentration-QTc prolongation assessment
Protocol concepts for Phase 1 studies evaluating drug-drug interaction, food-effect, effect of renal/hepatic impairment, ADME, TQT, BE/BA study, etc.
Review Phase 2/3 clinical trials where PKPD samples are utilized for dose optimization
Pediatric Study Plans (PSP)
Noncompartmental analysis of pharmacokinetics data from Phase 1 studies
Overall strategy of clinical pharmacology study planning (Must-know vs. good-to-know)
Report abuse