11 Coventry Ln,
Stoneham, MA 02180

Services

Pre-IND to IND

XP Pharma Consulting works with you to estimate starting doses and dose ranges for the first-in-human trials. We offer following services:

Noncompartmental PK Analysis (NCA)

  • NCA analysis with validated software tools
  • NCA analysis results (tables, listings, and figures)
  • PK-dose proportionality
  • NCA analysis results interpretation
  • Submission ready reports

Population PK/PD Modeling & Simulation

  • Allometric scaling
  • Dose selection and justificatio
  • Study design simulations
  • Human exposure prediction
  • Human PK/PD simulation

Clinical Pharmacology Strategy & Writing

  • Gap analyses/Question Based Review (QBR)
  • Clinical pharmacology plans
  • Clinical study designs
  • Study protocols (in full or in part) and reviews
  • Study reports (in full or in part) and reviews
  • Regulation documents preparation (PK/PD)
  • IND study protocol authoring (in full or in part) and reviews
  • Clinical development plans (in full or in part) and reviews
  • Responses to regulatory questions (in full or in part) and reviews
  • Comparator PK/PD data analyses

Early Phase

XP Pharma Consulting works with you to create plans to ensure that each study fits with your overall drug development program and facilitates efficient and timely data generation, analysis, and reporting. We offer the following services:

Noncompartmental PK Analysis (NCA)

  • NCA analysis with validated software tools
  • NCA analysis results (tables, listings, and figures)
  • PK-dose proportionality
  • NCA analysis results interpretation
  • Submission ready reports

Population PK/PD Modeling & Simulation

  • Population PK analysis
  • PK exposure-response (E-R) analysis
  • oncentration -QT analysis and modeling
  • Dose selection and justification
  • Study design simulations

Clinical Pharmacology Strategy & Writing

  • Gap analyses/Question Based Review (QBR)
  • Clinical pharmacology plans
  • Clinical study designs
  • Study protocols (in full or in part) and reviews
  • Study reports (in full or in part) and reviews
  • Regulation documents preparation (PK/PD)
  • Regulatory meeting representations
  • Comparator PK/PD data analysis
  • Clinical Pharmacology Studies

Late Phase

You have successfully completed several early phase studies. Now XP Pharma Consulting works with you utilizing quantitative tools and strategies that facilitate successful data interpretation and reporting. We help you design pivotal studies that will generate the PK/PD data required to secure a successful clinical pharmacology package for NDA/BLA filing. We employ innovative modeling and simulation techniques to justify the doses in the labeling, avoid certain late-phase studies, build a bridge strategy to pediatricpopulations, simulate clinical studies under different scenarios, and more:

Clinical Pharmacology Strategy & Writing

  • Gap analyses/Question Based Review (QBR)
  • Clinical pharmacology plans
  • Clinical study designs
  • Study protocols (in full or in part) and reviews
  • Study reports (in full or in part) and reviews
  • Regulation documents preparation (PK/PD)
  • Regulatory meeting representations
  • Comparator PK/PD data analysis
  • Clinical Pharmacology Studies

Noncompartmental PK Analysis (NCA)

  • NCA analysis with validated software tools
  • NCA analysis results (tables, listings, and figures)
  • PK-dose proportionality
  • NCA analysis results interpretation
  • Submission ready reports

Population PK/PD Modeling & Simulation

  • Population PK analysis
  • PK exposure-response (E-R) analysis
  • oncentration -QT analysis and modeling
  • Dose selection and justification
  • Study design simulations
  • Comparator PK/PD analyses

Clinical Pharmacology Studies

Clinical pharmacology studies are necessary for understanding the PK and PD properties of your drug. XP Pharma Consulting works with you to evaluate regulatory feedback and available data to identify the necessary studies. XP Pharma Consulting can assist in generating the study design, synopsis, and protocol for trials of following types:

  • First-in-human (FIH)
  • Single ascending dose (SAD)
  • Multiple ascending doses (MAD)
  • Bioequivalence
  • Relative bioavailability
  • Food effects
  • Drug-drug interactions (DDI)
  • Thorough QT (TQT)
  • Pediatric PK/PD bridging to adult dose study
  • PK in hepatic-impaired subjects
  • PK in renal-impaired subjects
  • Radio-labeled mass balance (ADME and metabolic profiling)

NDA/BLA Filing

You have successfully completed early-phase and late-phase clinical studies after significant investment. Now XP Pharma Consulting works with you to prepare NDA/BLA submissions and ancillary materials and documentation.

Regulatory Writing & Strategy

  • Integrated PK and PK/PD analyses and reports
  • NDA/BLA (CTD modules 2.7.1 and 2.7.2)
  • PK and PD sections of the label
  • Integrated immunogenicity analyses and reports
  • Responses to questions in the review period
  • Regulatory representation
  • Ad hoc PK/PD analyses
  • Manuscripts, posters, conference presentations