Clinical Pharmacology Studies

• First-in-human (FIH)
• Single ascending dose (SAD)
• Multiple ascending doses (MAD)
• Proof-of-Concept
• Bioequivalence
• Relative bioavailability
• Food effects
• Drug-drug interactions (DDI)
• Thorough QT/QTc (TQT)
• Pediatric PK/PD bridging
• PK in hepatic-impaired subjects
• PK in renal-impaired subjects
• Radio-labeled mass balance
• Large Registrational Safety and Efficacy, to establish population PK and exposure-response (PK/PD)
• Pediatric and Elderly

Clinical pharmacology studies are necessary to characterize your drug’s pharmacokinetics (PK) and pharmacodynamics (PD) properties and for dosing instructions on the label. XP Pharma Consulting works with you to identify the necessary clinical pharmacology studies based on available nonclinical, DMPK, pharmacokinetic, pharmacodynamic, clinical data, and industry standards.  We are confident in our recommendations to ensure you have what you need to achieve regulatory success for your drug development and registration.  XP Pharma Consulting has extensive experience in clinical pharmacology plan, study design, protocol authoring, PK/PD data analysis, study monitoring, and study reporting for various clinical pharmacology study types.