Xp Pharma Consulting, Llc

XP Pharma Consulting is a service provider specializing in the design and implementation of clinical pharmacology-guided and model-informed drug development across the drug development spectrum and through registration. Our Expert Services: Noncompartmental PK Analysis (NCA) • NCA analysis with validated software tools • NCA analysis results (tables, listings, and figures) • PK-dose proportionality assessment • NCA results interpretation and authoring reports Pharmacometrics Modeling & Simulation • Population PK analysis • PK exposure-response (E-R) analysis • Concentration-QT analysis and modeling • Dose selection and justification • NONMEM data set preparation • Identify intrinsic and extrinsic factors impacting PK exposure • Dose simulations for different populations and formulations • Author submission-ready reports • Clinical Pharmacology Strategy and Writing • Clinical pharmacology plan • Regulation document preparation (PK/PD) • Responses to regulatory questions • Gap analyses and mitigation strategy • Author clinical study protocols and reports • Dose rationale and justification • PK/PD design in protocols • DDI waiver justifications • TQT waiver justification • PIP and PSP for EU and US regulatory Clinical Pharmacology Studies • First-in-human (FIH) • Single ascending dose (SAD) • Multiple ascending doses (MAD) • Bioequivalence /Relative bioavailability • Food effects • Drug-drug interactions (DDI) • Thorough QT/QTc (TQT) • Special populations • Radio-labeled mass balance and ADME NDA and BLA Filing • Authoring CTD m.2.7.1, m.2.7.2 and contributes to other modules • USPI and SmPC PK and PD sections • Integrated PK and PK/PD analyses • Integrated immunogenicity analyses • Regulatory representation • Ad hoc PK/PD analyses