Clinical Pharmacology Studies

Clinical pharmacology studies are necessary for characterizing the PK and PD properties of your drug and needed for dosing instruction in the label. XP Pharma Consulting works with you to identify the necessary studies based on available clinical and non-clinical data according to industry guidance documents. XP Pharma Consulting can assist in study design, protocol authoring, PK/PD data analysis, study monitoring, and study reporting for trials of following types:

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

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11 Coventry Ln,
Stoneham, MA 02180

Clinical Pharmacology Studies

Clinical Pharmacology Studies